Chronic pain health needs assessment report version 0 3 by Jammi N Rao

Health Needs Assessment for Chronic Pain Jammi Rao, Editor with support and contribution of Sadia Janjua, Janine Dretzke, Daniel Eayres, Chris Chiswell, Version History Document Title Version

0.3

Author

West Midlands Commissioning Support Unit

Publication Date

12 November 2012

Review Date Supersedes/New

Version 0.2

Comments

This version incorporates changes agreed at meetings between EA, DE, AFS, CC and SJ. Major review and rewrite of the evidence review section; evidence tables recast and moved to the appendix with a commentary on each SR in the main text; DEâ&#x20AC;&#x2122;s sestion on epidemiology and prevalence of the major subtypes of chronic pain, CCâ&#x20AC;&#x2122;s new section on cli nical pathway for chronic pain and specialised services definitions for chronic pain treatments delivered as part of the specialised services commissioning process

Previous versions Version

Date Changes

0.1

21.08.2012

First draft sent to EA for comments re style , layout and outline content

0.2

14.09.2012

Planned changes including a) exec summary; b) Corporate needs assessment chapter out in, c) some editorial and technical tidying up of content including Table and chart references, bibliographic references, and spellings and typographic errors. This version was sent to the Black Country Clinical Senate in time for 36.09 meeting agenda. There was not the time before his deadline to address the comments made by EA to version 0.1

Chronic pain health needs assessment

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Contents Executive summary................................................................................................5 1

Introduction ........................................................................................................ 8

Background ......................................................................................................... 9 Health needs assessment ............................................................................................ 9 The national context .................................................................................................. 10 The Nature of Chronic Pain........................................................................................ 12

Epidemiology of chronic pain............................................................................. 14 Definitions .................................................................................................................. 14 Sub-classification of chronic pain .............................................................................. 15 Most common sites of chronic pain .......................................................................... 19 Incidence and prevalence of chronic pain conditions ............................................... 19 The natural history of chronic pain ........................................................................... 37

The economic costs of chronic pain ................................................................... 38 NHS Expenditure on chronic pain .............................................................................. 38 NHS chronic pain expenditure in the West Midlands ............................................... 43 Notes on Programme Budget data quality and limitations ....................................... 47

Health service utilisation - outpatient activity .................................................... 52 Commissioner perspective ........................................................................................ 52 out-patient activity – provider perspective ............................................................... 58

Health service utilisation – inpatient and day case procedures ........................... 61 Data sources and methods ........................................................................................ 61 Results........................................................................................................................ 62 Trends in Specific Procedures in pain management ................................................. 69 Analysis by provider Trusts ........................................................................................ 72

Stakeholder and Corporate needs Assessment................................................... 74 Chronic Pain – Stakeholders ...................................................................................... 74 Chronic Pain – Service Delivery ................................................................................. 79 Commissioning chronic pain services ........................................................................ 82 Measuring Outcomes ................................................................................................ 84 Recommended Core Outcome Measures in Research .............................................. 85

Chronic pain health needs assessment

Taxonomy of Chronic Pain Services ........................................................................... 86 Pathways for Chronic Pain Patients ........................................................................... 90 8

Rapid evidence review of the effectiveness of interventions for chronic pain. .... 96 Objective .................................................................................................................... 96 Methods ..................................................................................................................... 96 Search methods for identification of studies ............................................................ 96 Data collection and analysis ...................................................................................... 97 Results........................................................................................................................ 98 Manual therapy ......................................................................................................... 98 Pharmacological procedures ..................................................................................... 98 Patient education. ................................................................................................... 100 Physical treatments ................................................................................................. 100 Behavioural (BT) and cognitive behavioural therapy (CBT) .................................... 102 Invasive procedures ................................................................................................. 103 Multi-disciplinary interventions (MDI) .................................................................... 108 Appendix I â&#x20AC;&#x201C; Admitted Patient Commissioning Data Set (CDS) data request specifications ........................................................................................................... 111 Appendix II â&#x20AC;&#x201C; Pain management procedure codes.................................................. 114 Appendix nn ............................................................................................................. 118 Appendix nn ............................................................................................................. 120

Chronic Pain Health Needs Assessment

EXECUTIVE SUMMARY 



Chronic pain is widely prevalent, affecting an estimated 7.8 million people in England. It is not one specific disease entity, rather it is a syndrome that usually involves more than self reported pain in a particular anatomic location. Estimates of the prevalence of chronic pain vary between surveys, depending on the definition used, whether disability and interference with normal function is taken into account, the country location of the study and the method of epidemiological enquiry. In the UK the prevalence is probably between 11 and 13% of the adult population. Referrals to pain management clinics are growing across the West Midlands. Total outpatient attendances rose from 44,700 5 years ago to 51,587 in 2011/12. Just under a third of these attendances are first appointments. The crude rate of pain clinic attendances as 11.7 per 1000 population, suggesting that a substantial proportion of the estimated cases that are prevalent in the population are either self-managed or managed in the primary care setting. There is wide variation between PCTs and between PCT clusters. In keeping with the rise in out-patient attendances, clinical interventions and procedures in hospital for the management of chronic pain also show a rise in recent years – from 27,694 5 years ago to 32,444 in 2011/12. Joint injections (43%), spinal operations (19%) and epidural injections (17%) make up almost 80% of all procedures. The majority of interventions (86%) are carried out as day cases. There is a paucity of high quality research evidence to support the use of the many treatments and interventions that are commonly deployed in the management of chronic pain. Many of the published clinical trials suffer from methodological problems such as small sample size, inadequate description of the intervention, short duration of follow up, failure to achieve blinded assessment of outcomes, high rates of losses to follow-up and failure to use validated measures of outcome. Systematic reviews of the available clinical trials are available but they are necessarily limited by the lack of quality in the underlying clinical trials.

In the case of chronic low back pain,    



the evidence does not support the routine use of MRI as a diagnostic aid. Surgical treatment based exclusively on MRI findings is not supported by the evidence. Facet joint injections are of little proven value in chronic low back pain. Spinal cord stimulation in cases of failed back surgery syndrome may confer pain relief more effectively than either conventional medical management or re-operation, but the risk of complications needs carefully to be considered. Surgical operations on the spine when performed in carefully selected patients with lumbar intervertebral disc prolapse may provide faster pain relief than conservative management but the effect on longer term outcomes is uncertain. The risk of complications needs

Chronic Pain Health Needs Assessment



 

carefully to be considered and set against the risk of progression when neurological symptoms are present. There are several interventional procedure guidance documents produced by NICEThese include laser decompression, mechanical decompression, coblation, endoscopic laser discectomy and endoscopic laser foraminoplasty. In all these instances the data on safety and efficacy are not robust enough to allow them to be done without special arrangements for consent for audit and research. Cognitive behavioural therapy and other psychological therapies may offer short term benefit but the quality of research evidence on longer term outcomes is much weaker. Multi-disciplinary pain management programmes show promise of effectiveness with moderately strong evidence from systematic reviews; but the underlying clinical trials are of variable quality, with weak evidence for long term outcomes. There is support for such programmes in the various guidelines that are available.

In the case of chronic pain other than chronic low back pain: 



  

   



The available evidence does not support the use of electrotherapy, auriculotherapy and acupuncture, low level laser therapy for neck pain and for carpal tunnel syndrome. The generally poor quality of the trials makes it difficult reliably to draw conclusions without the risk of bias. Injections of Botulinum toxin-A may show some short term benefits in some cases, but the quality of the trials lead to a conclusion of insufficient evidence for long term benefit in neck pain, shoulder pain, myofascial pain, chronic musculoskeletal pain, or the pain of lateral epicondylitis (tennis elbow) Interlaminar epidural injections may confer some short term benefit in chronic neck and upper limb pain but the trials were small and the quality of evidence was poor. Intra-articular steroid injection in osteoarthritis was shown to confer significant clinical benefit in but the effect disappears in 3-4 weeks. Repeated injections of hyaluronic acid in knee osteo-arthritis was shown to confer short term symptom relief but the evidence of disease modification in the long term is at best speculative. Manipulation or mobilisation in subacute or chronic neck pain produces short term benefit but long term data are lacking. Mechanical tyraction for chronic neck pain with or without radiculopathy is not statistically significantly different from placebo. Manual therapy and exercise in neck pain significanlt reduces pain and improves quality of life, though the effect on radiculopathy is uncertain. Gabapentin and pregabalin are effective in reducing pain in neuropathic pain and fibromyalgia. Some studies suggest that the effect may extend to other outcomes such as a return to work. Carbamazepine is also effective in reducing pain in chronic neuropathic pain but side effects may limit its use. Lamotrigine is not effective in treating chronic pain. Valproic acid is probably not effective in neuropathic pain and fibromyalgia.

Chronic Pain Health Needs Assessment



  

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The evidence base for opioids is mixed. Patients able to continue long term opioids experience significant clinical benefit, even though the evidence for quality of life and functional improvement is inconclusive. Cannabinoids are safe and effective in neuropathioc pain and probably also in fibrimyalgia and rheumatoid arthritis. Antidepressants are effective in improving pain scores in the treatment of neuropathic pain. Surgical interventions such as sympathectomy (whether done surgically, chemically or by radiofrequency ablation) may achieve significant reduction in pain score but the trials were small and did not include a placebo arm. Intrathecal delivery of drugs using implantable devices is supported only by low quality evidence; they are associated with high rates on reversal and infrequent but serious complications. Multi-disciplinary interventions in chronic pain offer a safe and effective option for many chronic pain syndromes. It remains unclear which of the components are critical for patient benefit. Patient education programmes have not been shown to be effective. Behavioural and psychological therapies in isolation have weak effects in improving pain.

Chronic Pain Health Needs Assessment

1 INTRODUCTION 1.1

Chronic pain is a common and universal condition that has a major impact on the lives of the many millions of people affected by it. Widely quoted estimates of its prevalence suggest that as many as 7.8 million people in the UK may be affected by chronic pain of at least moderate severity.

1.2 Chronic pain may be both a symptom of an underlying disease and, more commonly, an illness or syndrome in its own right. In the latter situation, it can have a substantial adverse effect on quality of life and well-being due to unemployment, sleeplessness and depression. However it is relatively recently that chronic pain has come to be recognised as a public health problem that calls for a different approach to the traditional one based on regarding pain as a symptom for which there must be a pathological cause that is amenable to diagnosis and treatment. Concepts are evolving for the assessment of chronic pain in people without an underlying cause based on an understanding of chronic pain as a distinct condition that merits a different approach to management. 1.3 While the majority of cases of chronic pain in population based epidemiologic studies are accounted for by three categories â&#x20AC;&#x201C; pain following trauma, low back pain, and arthritis and osteoarthritis â&#x20AC;&#x201C; there are some disease entities that present major diagnostic and management challenges. Fibromyalgia or chronic widespread pain is an example of such a condition where the experience of pain and the consequent effects on daily life itself leads to further pain and disability. Because of their chronicity and the lack of effective curative treatments such cases tend to take up a disproportionate amount of time from both primary care and specialist services. 1.4

There is a close inter-relationship between work, the experience of pain and the availability of welfare payments for those deemed unfit for work. The initial experience of pain leads to a prescription of rest and abstention from work and activity; this in turn leads to deterioration of the original problem which, coupled with welfare payments, acts as a disincentive to an early return to work. Acute pain is often the trigger for a prescription of time off work, leading to chronicity, welfare dependency and continuing chronic pain.

1.5 It is timely therefore to carry out a health needs assessment for chronic pain. In the following pages this report will consider The nature and patho-physiology of chronic pain Estimates of the prevalence of chronic pain The use of specialist hospital services for the treatment and management of patients with chronic pain; and the trends in the use of selected surgical procedures Trends in the use of pharmacological agents The effectiveness of treatment and management options available for the management of chronic pain.

Chronic Pain Health Needs Assessment

2 BACKGROUND HEALTH NEEDS ASSESSMENT 2.1 Health needs assessment (HNA) is a formal and structured method to understand the need for health care and related services and support in a defined population, usually in respect of a specified health or disease based topic. While individuals can also go through a process of assessment as to their health and/or healthcare needs, HNA is usually applied to whole populations or large subgroups thereof. HNA makes clear the distinctions between need, demand and supply. 2.2 Need is defined as the capacity to benefit. It therefore follows that need can exist only when there is an effective intervention to ameliorate the condition and resources are available with which to procure the intervention. 2.3 Demand is what patients ask for, based on their lived experiences, what they know and understand of their condition, and their knowledge and experience of the services and treatments they expect to be available. It can be more or less than normative need, and is often influenced by many factors including the media, advertising by suppliers and anecdotal accounts of their peers. In health care, supply of services often generates its own demand. 2.4 Supply refers to the health care that is provided; it is determined by the interests and priorities of professionals, the political process and the resources that are made available. Newer treatments are often supplied with the expectation that it will generate its own demand and before the need for them has been fully and unarguably established by high quality research. 2.5 HNA has the potential to tease out these conflicting and overlapping concepts and make explicit the choices available to commissioners together with a clearer understanding of likely impacts of their decisions. Seen in this light, HNA is not an isolated activity but an integral part of the process of commissioning health care. 2.6 The traditional model of HNA is a composite of 3 separate but interlinked exercises: Epidemiological needs assessment consists of the use of available data and information from whatever sources may be available to draw a picture of the scale of the condition or disease in question; its distribution among segments of the population defined by age, gender, ethnicity, social class, deprivation, and geographic location. Comparative needs assessment sets the local findings in the context of the region and the country. Comparisons are also possible with other areas of the country that share the same or similar socio-demographic, economic and cultural characteristics. Corporate needs assessment takes account of the views of key stakeholders involved in the provision of current services. 2.7

A distinction is also often drawn between healthcare needs and health needs assessment. In practice the term HNA is often loosely used to include both; it is helpful however to be clear of the distinction. Healthcare needs assessment confines itself to the clinical and other curative and/or professionally delivered support and services that

Chronic Pain Health Needs Assessment

can be delivered. Health needs assessment takes a broader, more holistic approach and considers also the wider determinants of health that can often make a big difference to the outcomes that people and communities experience and value. This report will confine itself to healthcare needs of people with chronic pain.

THE NATIONAL CONTEXT 2.8 Chronic pain is not formally identified in any national service framework or policy document as a priority for the health service. It is implicitly included in policy statements and guidance documents that relate to the underlying diseases that give rise to chronic pain. 2.9 In March 2000 the Clinical Standards Advisory Group (CSAG) produced a report (1), ‘Services for Patients with Pain’, at the request of Ministers ‘to advise on standards of clinical care for patients with acute and chronic pain and on access to and availability of services.’ A part of their report was based on a study carried out by a team from Manchester and Leicester Universities in 1997 in 12 acute hospital trusts. The report found that there was wide variation in the provision of services, with acute pain better catered for than chronic pain. Some hospital services were poorly organised with lack of dedicated time from consultants and an agreed role for specialist nurses. Among other findings: An estimated 7% of the population suffers chronic pain at any one time. A quarter of the population suffers from bouts of musculoskeletal pain, especially in the back. Most people treat themselves or seek help from their general practice. In most areas, pain services were ‘part of the package’. There were few explicit contracts for pain relief and not much by way of needs assessment. Local guidelines where they existed were of poor quality. Chronic pain services were poorly resourced and were unable to cope with the demands placed on them. Shortages of staff trained in psychology, occupational therapy, physiotherapy and of dedicated pharmacist support prevented a multi-disciplinary approach to management. Routine data and information systems did not record activity and outcomes in a systematic and meaningful way to allow evaluation of the services that were offered. Professionals thought that chronic pain as an issue had less of a profile than palliative care and it was difficult to attract investment in services. There was little by way of integration between different parts of the service either between general practice and specialist pain clinics or between pain specialists and other medical specialties. Specialist pain services often discharged fewer patients than they took on, building up a backlog of referrals and leaving patents feeling that their condition was not taken seriously. 2.10 In 2008 the Chief Medical Officer, Sir Liam Donaldson highlighted the problem of chronic pain in his Annual Report (2). He stated that ‘...millions of people experience chronic pain... imposing a heavy burden on them, their families and the economy at large. Although we now have effective means of tackling both pain and the consequences of pain, services have not kept up with demand and too many people struggle to cope with their symptoms.’ The report concluded:

Chronic Pain Health Needs Assessment

Pain is the most common symptoms and affects 7.8 million people in England. Chronic pain is more prevalent now than it was 40 years ago. All age groups are affected: a quarter of school age children reported pain lasting on average more than 3 years; most elderly residents of nursing homes experienced frequent moderate to severe pain. Pain and its effects are costly. Back pain alone is estimated to cost the economy ÂŁ12.3 billion each year. Not enough is being done to implement programmes to treat pain early and effectively and thus stop pain becoming persistent. Specialist services are inadequate and unable to cope with the demand. Only 14% of people with pain have seen a pain specialist. 2.11 In Nov 2004 a research project by Dr Foster(3) reported on a survey of adult chronic pain management in primary care. This survey was carried out in association with the Long Term Medical Conditions Alliance, a charity representing the voice of patients, carers and service users, and was funded by an educational grant from NAPP Pharmaceuticals, a company that makes and sells drugs used in pain management. Among the important conclusions of this survey are: Chronic pain management is not a healthcare priority in the UK. 64% of primary care organisations (PCOs) failed to allocate specific funding for services in a primary care setting. Only 20% reported having a formal or structured chronic pain management service delivered in primary care. Only 4% of PCOs reported having a practice based register of people with chronic pain. 69% of PCOs reported that they did not have specific guidelines or recommendations for the management of non-cancer chronic pain. Only 8% of PCOs allocate part of their education and training budget to GP training for in the management of chronic pain. The provision and organisation of primary care chronic pain management services varies across the country. There is acknowledgement that there is insufficient money allocated to chronic pain services; that staff is poorly equipped to manage chronic pain; and that prescribing and management guidelines are needed. 2.12 In 2011 the Healthcare Quality Improvement Partnership, Dr Foster Intelligence and the British Pain Society reported on the first phase of the National Pain Audit(4) â&#x20AC;&#x201C; a three year study set up in October 2009 that aims to establish a national data collection system to monitor performance of pain services. The audit covers all specialist pain services in England and Wales and reports organisational performance against a wide range of standards set by the faculty of Pain medicine, British Pain Society and the International Association for the Study of Pain. The results of this first phase of the audit showed: A total of 214 services were identified in England and Wales. Most PCTs reported between 1 and 3 specialist services for their populations. The poorest returns were for the Midlands and the South East. Most services reported meeting the NHS waiting time targets. The extent to which this also met the needs of patients is not known

Chronic Pain Health Needs Assessment

64% of Services in England assessed themselves as â&#x20AC;&#x2DC;multi-disciplinaryâ&#x20AC;&#x2122;. But using stricter criteria to define the label in terms of the presence of key personnel, only 40% would meet this standard. Services claiming to offer specialist treatments and interventions often lacked the appropriate staff (as assessed by their own data returns). Training for staff was not available for the majority of services.

THE NATURE OF CHRONIC PAIN 2.13 Pain is the oldest affliction known to man. In traditional medical practice pain is traditionally seen as an important and useful symptom of an underlying disease. Its severity, nature, fluctuation and how it responds to or is exacerbated by physical stimuli are all useful pointers to an underlying pathology or disease process and therefore to a therapeutically useful clinical diagnosis. When successful and effective treatment of the underlying condition relieves the pain it provides comfort to the patient and satisfaction to the doctor that the diagnosis was correct. 2.14 While this concept is helpful in acute short lived pain, it is less so when the pain continues for more than a few days or weeks, or when the presumed underlying diagnosis and its treatment fail to relieve the pain. Should pain therefore be regarded as a disease or syndrome in its own right, quite independent from any presumed causative disease process? 2.15 Croft (5) presents a compelling argument that chronic pain fits the criteria for a condition independent of any underlying disease and one that merits definition by reference to the subjective experience of pain, its severity, and duration. Clinical experience amply demonstrates individual variation in the experience of pain following equivalent tissue injury. At population level, variations of the prevalence of chronic pain with social class, income levels and gender suggest the existence of risk factors that would allow a public health approach to chronic pain. Physiological evidence from neuro-imaging studies (PET, functional MRI, EEG and magnetoencephalography) points to distinct and identifiable structural and functional changes in the brains of patients with chronic pain (6,7). There remains uncertainty whether these changes lead to or result from the chronic pain. 2.16 These ideas have led to the emergence of the concept of chronic pain as a condition or disease or syndrome in its own right. The trigger for the initial experience of pain may be an external injury or disease but other factors such as an underlying propensity to chronicity, the availability or lack of fast effective treatment, the presence or lack of a supportive environment for recovery, and a range of social and economic factors that determine the level of motivation of the individual come together to determine whether the end-result is chronic pain. 2.17 The distinction between the traditional biomedical view of pain-as-symptom-of-disease and the emerging view of pain as a biopsychosocial condition (i.e. with a biological basis at origin but with psycholigical and sociological determinants that justify viewing chronic pain as a distinct disease entity) has practical implications . By viewing pain as a symptom it is tempting for the patient to seek, and for the doctor to provide, extensive

Chronic Pain Health Needs Assessment

diagnostic work-up and repeated trials of therapeutic interventions in the search for a cure that may not in reality be possible. Indeed the pursuit of such diagnostic and therapeutic interventions perpetuates in the mind of the patient the notion that the pain is a symptom and acts as a barrier to consideration of the alternative model. In contrast, the model of chronic pain as a specific disease allows alternative and potentially more effective interventions to be considered and found acceptable.

Chronic Pain Health Needs Assessment

3 EPIDEMIOLOGY OF CHRONIC PAIN DEFINITIONS 3.1

From a clinical perspective, chronic pain exists when the patient feels that the pain is not improving with readily available routine treatments. Pain itself is a subjective symptom that the patient relates and therefore any distinction between acute and chronic pain must also be led by the patient. However, for the purpose of epidemiological study of the prevalence of chronic pain in the population, we need a clear definition even if its use in questionnaires is dependent upon the subjective experience of patients.

3.2

The International Association for the Study of Pain (IASP) has defined pain as: "An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage" (8)

3.3

Pain is classified by its chronicity (acute / chronic) and by whether the original underlying tissue damage occurred within the nervous system or elsewhere (neuropathic / nociceptive).

3.4

Acute pain is pain that is caused by occurrences such as traumatic injury, surgical procedures, or medical disorders and which is short-lived, resolving during an appropriate healing period.

3.5

Chronic pain is used to describe pain that is continuous, long-term or enduring beyond the expected healing time. Pain itself is a subjective symptom that the patient relates and therefore any distinction between acute and chronic pain must also be led by the patient. However, for the purpose of epidemiological study of the prevalence of chronic pain in the population, we need a clear definition even if its use in questionnaires is dependent upon the subjective experience of patients. The IASP defines chronic pain as: â&#x20AC;&#x153;Pain without apparent biological value that has persisted beyond the normal tissue healing time (usually taken to be 3 months)â&#x20AC;? [Citation needed]

3.6

With chronic pain the patientâ&#x20AC;&#x2122;s presentation becomes more complex. There may be psychological features, including complaints of poor or non-refreshing sleep, tiredness, depression and poor concentration. Please note that this definition does not exclude the presence of an underlying pathology.

3.7

The stated duration of 3 months is somewhat arbitrary but has come to be regarded as the standard by most pain experts. In clinical practice some patients may approach doctors for help sooner or later than the 3-month cut off period; some clinicians too may be inclined to refer patients for help at an earlier stage; however, the IASP definition serves as a useful, simple and practical definition to use in studying the population prevalence of chronic pain.

3.8

For many underlying diseases and for many patients, pain is not constantly present; and when it is constant the intensity often fluctuates. This variability in the experience of pain is captured by the World Health Organisation (WHO) definition of chronic pain as [Citation needed]:

Chronic Pain Health Needs Assessment

“Current and persistent pain that has been present most of the time for 6 months or more” 3.9

Other definitions that have been used in studies include: [IASR 2003] “Recurrent or continuous pain for more than 3 months” “Pain on most days for more than 3 months” “Pain every day for more than 6 months” “Pain or discomfort, continuous or intermittent, for more than 3 months”

3.10

There are other pain syndromes where there is enough known about the natural history of the underlying disease process to allow a definition that is not so dependent on duration alone. For example, post herpetic pain and the pain of trigeminal neuralgia follow very different courses in the ‘average’ case. An exceptional situation is that of fibromyalgia, an ill-defined condition that has become prominent in recent years and differs from other pain syndromes in its lack of definition in terms of the site of the pain and in many cases by its widespread nature. The term fibromyalgia is seen as unhelpfully suggesting the tissues involved with little or no evidence in support. Pain experts prefer the term Chronic Widespread Pain (CWP). The American College of Rheumatology (9) defined CWP as pain that has lasted for more than 3 months in at least two contra-lateral quadrants of the body together with pain in the axial skeleton. This leads to some loss of specificity for the most severe cases and a group from Manchester proposed what is known as modification that has come to be known as the Manchester definition (10): pain that has persisted for more than 3 months in at least two sections of two contra-lateral limbs together with pain in the axial skeleton.

3.11

Pain can be classified clinically as either nociceptive or neuropathic, although in practice these can co-exist (mixed).

3.12

Nociceptive pain (tissue damage pain) arises from mechanical, chemical or thermal stimulation of nociceptors (e.g. after surgery, trauma or associated with degenerative processes such as osteoarthritis). It is important to realise that pain may persist long after the nociceptive process has ended and that other factors, e.g. psychosocial features, may need to be considered.

3.13

Neuropathic pain (nerve damage pain) is initiated or caused by a primary lesion, dysfunction, disease or pathological change in the central or peripheral nervous system (e.g. in conditions such as diabetic neuropathy or spinal cord injury). It has quite different clinical features from nociceptive pain. It is less well localised and often is described as burning or shooting. It can occur in areas that are numb and where there is no tissue damage. It commonly presents in primary care and can be difficult to diagnose.

SUB-CLASSIFICATION OF CHRONIC PAIN

Chronic Pain Health Needs Assessment

3.14

For the purpose of health needs assessment pain needs to be described in terms of subcategories of need. McQuay et al describe such a categorisation based on an audit of demand at a pain clinic over a one month period. (11) The categorisation does not use the mechanism of pain, apart from the generic grouping of neuropathic pain, giving the following categories:       

Musculoskeletal Cancer MUPS (medically unexplainable painful syndromes) Face/head Neuropathic Vascular Chronic postoperative pain.

Examples of conditions under each of these categories is given in Table 1. 3.15

The rationale given for including cancer as a category was that pain clinics commonly provide invasive options for cancer pain at the behest of the palliative care team. [Text here on whether/why we are excluding/ including cancer in the remit of this report]

Table 1 :Sub-classification of chronic pain Musculoskeletal

Back

Neck Fibromyalgia/myofascial Arthritis Cancer

Breakthrough cancer pain

MUPS (medically unexplained painful syndromes)

Face/head pain

Neuropathic

degenerative disc disease osteoporotic collapse stenosis facet joint post-trauma/surgery ankylosing spondylitis no clear pathology degenerative disc disease whiplash polymyalgia rheumatica osteoarthritis, rheumatoid neuropathic, movement related, poor control with oral morphine non-cardiac chest pain abdominal pelvic chest pain

Migraine Headache Trigeminal neuralgia Dental

atypical facial diabetic neuropathy postherpetic neuralgia multiple sclerosis

Chronic Pain Health Needs Assessment

post stroke repetitive strain injury reflex sympathetic dystrophy (CRPS1) traumatic Vascular

Peripheral Central

Chronic postoperative pain

claudication/Raynaudâ&#x20AC;&#x2122;s angina pain after amputation (phantom and stump) chronic postoperative breast pain chronic postoperative thoracotomy pain chronic postoperative cholecystectomy pain

Source: McQuay et al, 2007(11) Musculoskeletal pain 3.16

Musculoskeletal pain is pain that arises in or affects the muscles, bones, joints, ligaments and/or tendons. It may be caused by degenerative diseases such as arthritis or degenerative disc disease, by a specific trauma or injury, by overuse, underuse (immobilisation), repetitive actions, poor body alignment, or may have no clear pathology.

3.17

Approximately half of this category is due to back pain. Back pain itself can be classified into neck pain (cervical), upper back pain (thoracic) and lower back pain (lumbo-sacral). Lower back pain is the commonest back problem.

Medically unexplained pain syndromes (MUPS) 3.18

These are conditions where the patient has symptoms for which no medical cause can be found. That is not to say that there is no physical cause, only that such a cause is uncertain, not determined or in dispute.

3.19

Conditions included in this category include chronic fatigue syndrome (CFS), myalgic encephalomyelitis (ME), and unexplained chest, abdominal, and pelvic pain. Symptoms of CFS and ME often include widespread muscle and joint pain and headaches. [Query overlap between CFS/ME and fibromyalgia/CWP in musculo-skeletal pain]

Face/head pain 3.20

This category included any chronic pain conditions occurring in the face or head. Examples are migraine, headache, trigeminal neuralgia, atypical facial pain and dental pain.

Neuropathic pain 3.21

As described above neuropathic pain is caused by a lesion, disease or pathological change in the central or peripheral nervous system. It may be caused by several, often overlapping, disease processes and represents a varying set of conditions rather than a single diagnosis. There is no universally accepted sub-classification but four broad classes of disease based on aetiology and anatomy are recognised: (12) ď&#x201A;ˇ focal and multifocal lesions of the peripheral nervous system ď&#x201A;ˇ generalised polyneuropathies of the peripheral nervous system

Chronic Pain Health Needs Assessment

 lesions in the central nervous system  complex neuropathic disorders Examples of conditions in each of these classes are given in Table 2.(13) 3.22

Neuropathic pain commonly presents in primary care, can be difficult to diagnose and is often unrecognised. Diagnosis is based on characteristic symptoms, altered sensation, and a clinical history that matches a neuroanatomical or dermatomal pattern.

Table 2: Neuropathic pain syndromes Sub-category Peripheral nervous system focal and multifocal lesions

Peripheral nervous system generalised polyneuropathies

Central nervous system lesions

Complex neuropathic disorders

Conditions Post-herpetic neuralgia Diabetic mononeuropathy Nerve entrapment syndromes Plexopathy from malignancy or radiation Phantom limb pain Post-traumatic neuralgia (such as nerve root compression, post-thoracotomy) Ischaemic neuropathy Metabolic/nutritional conditions: diabetes mellitus amyloid pellagra, beriberi multiple nutritional deficiency, hypothyroidism Toxic conditions: alcohol platinum or taxane based chemotherapy isoniazid antiretroviral drugs Infective/autoimmune conditions: HIV acute inflammatory polyneuropathy (Guillain-Barré syndrome) neuroborreliosis (Bannwarth’s syndrome) Heriditary conditions: Fabry’s disease Malignant conditions: Carcinomatosis Other: idiopathic small fibre neuropathy Spinal cord injury Prolapsed disc Stroke (brain infarction, spinal infarction) Multiple sclerosis Parkinson’s disease Surgical lesions (such as rhizotomy, cordotomy) Complex regional pain syndrome types I and II

Chronic Pain Health Needs Assessment

Sub-category Conditions Source: Freynhagen et al, 2009. (13) Vascular pain 3.23

Vascular pain is the pain resulting from central and /or peripheral vascular conditions such as coronary artery disease and atherosclerosis. Constriction or blockages of blood vessels restrict blood flow and starve the muscles of oxygen resulting in cramps and/or pain. This usually occurs under exertion or stress and is relieved by rest. Examples include claudication, ischaemic rest pain, Raynaud’s phenomenon and angina.

Chronic postoperative pain 3.24

Chronic postoperative pain is pain that persists after the expected healing time for surgery. It is usually focussed around the wound but may also radiate out to other parts of the body. Specific causes include damage to peripheral nerves or body tissue during surgery, scarring, and infection or inflammation at the site of the wound. Examples include pain following amputation (phantom limb pain, stump pain) , mastectomy, thoracotomy, and cholecystectomy, other postoperative abdominal and spinal pain; and failed back surgery syndrome.

MOST COMMON SITES OF CHRONIC PAIN 3.25

A WHO survey of chronic care in primary care across 15 centres in Europe, Asia, Africa and the Americas reported a prevalence of 22% of patients reporting ‘persistent’ pain.(14) The most common anatomical sites where the pain occurred are given in table C. Back pain was the most frequent affecting just under half of all those reporting pain. More than twothirds of patients reported pain in two or more sites.

Table 3: Anatomical site of pain Anatomical site Subjects reporting pain (%) Backpain 47.8 Headache 45.2 Joint Pain 41.7 Arm or leg pain 34.3 Chest Pain 28.9 Abdominal Pain 24.9 Pain Elsewhere 11.7 Number of anatomical sites 1 32.1 2 27.5 3 22.8 4+ 17.5 Source: Gureje et al, 1998. (14)

INCIDENCE AND PREVALENCE OF CHRONIC PAIN CONDITIONS

Chronic Pain Health Needs Assessment

3.26

A large number of studies have been carried out in many countries over many years to estimate the population prevalence of chronic pain conditions. The results are influenced greatly by a variety of factors, of which the most important are the definition of chronic pain used, the type of study undertaken (population survey or analysis of health records), method of interview (whether by telephone or face to face), the non-response rate, specific demographic characteristics of the population studied, the method by which the sample was drawn, and the specification of the sampling frame.

3.27

Given the intermittent, recurrent, episodic nature of chronic pain, careful consideration must also be given to the choice of measure of the disease frequency, particularly for the purposes of health needs assessment. The most commonly reported measures of incidence of new patients or the point prevalence of patients with chronic pain conditions provide limited information of the need faced by services. Ideally what is required is a measure of the frequency over a given period of time. A common measure reported by population surveys is the lifetime prevalence of a condition, i.e. what proportion of the population have ever experienced the condition at any point in their life thus far. This too is difficult to use for needs assessment. In most cases the best measure is period prevalence, i.e. the proportion of people who have experienced an episode of the condition during a defined time period, usually one year.

3.28

It is not the purpose of this report to review this vast literature in detail, rather it is to present reasonable estimates of the incidence and/or prevalence of the various chronic pain conditions to help quantify the burden of disease.

Chronic pain overall

3.29

The Chief Medical Officerâ&#x20AC;&#x2122;s report 2008 estimated that 7.8 million people in the UK live with chronic pain defined as â&#x20AC;&#x2DC;moderate to severe pain that has lasted over 6 monthsâ&#x20AC;&#x2122;, approximately 13% of the population.(2)

3.30

A European-wide pain survey in 2004 reported a similar prevalence figure of 18% in Scotland with only 3% of people accessing specialist pain clinics.(15) However in a 2007 health needs assessment for chronic pain McQuay et al reviewed a number of European and Canadian studies which mostly reported much a higher prevalence of up to 50% of the population.(11)These are summarised in

Chronic Pain Health Needs Assessment

3.31

Table 4.

3.32

These studies suggest that chronic pain increases in frequency with age and is more prevalent amongst women than men. Chronic pain may be particularly common in older people in nursing homes or long-term care institutions. (16) Musculoskeletal pain is the predominant sub-category. Two of the studies reported that for approximately half of those with chronic pain the pain was severe.

3.33

McQuay et al estimated a typical Primary Care Trust population to have a prevalence rate of patients with severe chronic pain of 5-10%.(11)

Chronic Pain Health Needs Assessment

Table 4: Studies of chronic pain prevalence Study

Location

Definition of chronic pain

Age group 25-74

Andersson 1993 (17)

Sweden

Duration > 3 months

Brattberg et al 1989 (18)

Sweden

Obvious pain Duration > 6 months

18-84

Birse & Lander 1998 (19)

Canada

Recurrent or persistent pain Duration > 6 months

18+

Bowsher et al 1991 (20)

Chronic pain lasting on or off Duration > 3months

15+

Chrubasik et al 1998

Germany

Prolonged pain in the previous 6 months

18-80

Elliott et al 1999 (21)

Scotland

Continuous or persistent pain Duration > 3 months

25+

Arnow 2006

USA

Currently troubled by pain all the time or on an d off Duration > 6 months

21-75

Prevalence findings Men: 50% Women: 50% Musculoskeletal pain most common. Prevalence increased with age. Men: 38% Women: 42% Musculoskeletal pain most common. Peak prevalence in 45-64 years olds. Men: 35% Women: 66% Musculoskeletal pain most common. Peak prevalence in older age group and young women. Persons: 11.5% Prevalence increased with age. Higher prevalence in women than men (1.5:1). Persons: 47% Of which: 87% > 1 year duration; 50% had severe pain; 29% severe and > 1year duration. Musculoskeletal pain most common. Persons: 47% Of which half had severe pain or disability. Musculoskeletal pain most common. Prevalence increased with age. Persons: 45% 33% reported non-disabling chronic pain. 13% reported disabling chronic pain. Persons with chronic pain were 5 times more likely to be suffering a major depressive disorder.

Chronic Pain Health Needs Assessment

Study

Location

Definition of chronic pain

Croft 2010

Various

SjĂ&#x2DC;gren 2009

Denmark

Chronic/long-lasting pain Duration > 6 months

Age group Adults

Prevalence findings Crude estimates based on a review of studies: Persons: 40% 25% prevalence for chronic pain interfering with life 10% prevalence for chronic disabling pain. Persons: 20% Higher in females and increasing age. Higher prevalence associated with divorce, separation or widowed, <10 years of education and high BMI. 66.6% of chronic pain due to musculoskeletal diseases.

Musculoskeletal pain 3.34

Musculoskeletal disorders are the most common cause of chronic pain. Parsons et al undertook a review of the literature for the incidence and prevalence of musculoskeletal conditions for the period 1999-2010.(22) They identified two studies providing population prevalence estimates for musculoskeletal pain overall: The Tameside Musculoskeletal Project reported a prevalence of self-reported musculoskeletal pain of 11% in adult men and 14% in women (13% for persons); the General Household survey 2006 reported similar figures for long-standing musculoskeletal conditions of 12.6% for adult men and 18.3% for women (15.6% for persons).(23,24)

Back Pain 3.35

Back pain is one of the commonest causes of disability and absence from work, particularly during the productive middle years of adult life.(25) Low back pain probably affects around one-third of the UK adult population each year. Of these, around 20% will consult their GP about their back pain.(26) From this we can estimate 2.9 million people in England (1 in 15 of the population) will seek advice about back pain from their GP each year.

3.36

The data for quantifying how much of this is chronic pain is less reliable. One of the reasons for this is the lack of agreement about definitions of chronic back pain, the different time periods used and its intermittent nature.

3.37

A 1997 low back pain health needs assessment by Croft et al identified two UK surveys reporting low back pain prevalence.(27) For both studies the one- year period prevalence for low back pain lasting more than one day was 38% of adults.(28,29) Rates did not vary much with age or gender. The OPCS study provided a breakdown by the number of days of pain experience during the year. It reported that 10% of adults had pain for more than 12 weeks and 6% for more than a year.

Chronic Pain Health Needs Assessment

3.38

A UK-based survey carried out by Webb et al in 1996, using a very broad case definition of self-reported ‘back pain lasting more than one day in the past 12 months’, found an annual period prevalence rate of 40% in adults. Using a more clinically relevant definition of pain reported as ‘lasting for the whole year’, adult prevalence was estimated as 15%.(30)

3.39

Hillman et al, in a two-phase survey carried out in Bradford, reported a one-year prevalence of low back pain of 39% in adults aged 25-64 years. A quarter of these were classed as chronic, lasting over 3 months (10%). For 62% of those with chronic low back pain, the condition was a long-standing problem with a history of five or more years.(31)

3.40

The COST European guidelines for the management of chronic nonspecific low back pain identified a number of reviews and studies of back pain prevalence.(32) One systematic review of 30 population prevalence studies of low back pain reported point prevalence of low back pain ranging from 12-33%, 1-year prevalence from 22-65% and lifetime prevalence from 11-84%.(33) A further study carried out in Sweden reported a prevalence of chronic low back pain lasting longer than 3months of 23%.(17)

3.41

The one year period prevalence of low back pain which radiates to the legs below the knees was 11% and is consistent with other studies reporting figures of 12 to 15% of all adults.(34,35)

3.42

The prevalence of true sciatica has been estimated at 5%.(36)

3.43

The OPCs study reported 10% of adults reported at least one day of moderate or severe disability, for 8% this was of more than 12 weeks duration. For 5% of adults disability was both severe and longer than 12 weeks duration. Scandinavian and Canadian studies have reported 10-12% of the adult population having low back problems that result in impairment of daily activities or high disability.(36,37,38)

3.44

The 2007 General Household Survey found 3.7% of men and 3.4% of women reported longstanding illness as a result of back pain.(24)

Table 5: One year period prevalence of low back pain by category and duration Category

By total days in pain in past year <12 weeks 12 weeks – All Year 1 year 28% 4% 6% 5% 2% 4%

Prevalence of low back pain (%) Prevalence of low back pain with leg pain (%) Prevalence of severe sciatica (%) 0.2% 0.3% Prevalence of moderate and severe 2% 3% disability (%) Prevalence of severe disability (%) 1% 2% The category ‘low back pain with leg pain’ includes severe sciatica. Source: Croft et al, 1997.(27)

Total

38% 11%

1.5% 5%

2% 10%

Chronic Pain Health Needs Assessment

3.45

Hillman et al reported an overall annual incidence rate for the onset of new back problems during the year, based on self-report from a questionnaire, of 4.7 per 100 (4.1 per 100 among men and 5.4 per 100 among women).(31)

3.46

The South Manchester Back Pain Study estimated a one year cumulative incidence for new ‘consulting’ episodes of 3.1 per 100 for men and 4.7 per 100 for women, and for new nonconsulting’episodes of 30.7 per 100 for men and 32.1 per 100 for women.(39)

3.47

In a German study of patients with chronic lower back pain, Freynhagen et al found 37% to have predominantly neuropathic pain. These patients showed higher ratings of pain intensity, with more numerous and more severe co-morbidities such as depression, panic/anxiety and sleep disorders. The study estimated that 14.5% of all female and 11.4% of all male Germans suffer from LBP with a predominant neuropathic pain component.(40)

Ankylosing spondylitis 3.48

Ankylosing spondylitis is a form of arthritis that mainly affects the lower back but may also include other joints or parts of the body. The ligaments of lower spine become inflamed and may stimulate bone growth resulting in vertebrae in the spine fusing together.

3.49

Studies have reported annual incidence rates for primary and secondary AS of 7.3 per 100,000 in the USA (41) and 8.7 per 100,000 in Norway.(42)

3.50

The Norway study reported point and period prevalence figures of 0.26% and 0.31% respectively. This compares to another Norwegian study that reported a point prevalence of 1,100-1,400 per 100,000.(43) A German study reported a point prevalence of 900 per 100,000 among blood donors in Berlin.(44) All studies report incidence/prevalence rates 3 to 6 times higher in men than in women.

3.51

The point prevalence of AS in the UK has been estimated at 1-2% of the population.(45) Although dated, this figure is consistent with the second Norwegian and the Berlin studies. The 4th RCGP survey (1991–92) reported an annual period prevalence for primary care consultations for AS in the UK of 40 per 100,000 (60 per 100,000 among men and 10 per 100,000 among women).(46)

3.52

McQuay et al’s Chronic Pain HNA reviewed pain prevalence in patients with AS and estimated 25-50% of AS sufferers experience chronic pain.(11) We estimate a point prevalence of 250 to 1000 AS patients with chronic pain per 100,000 population.

Neck pain 3.53

McQuay et al’s chronic pain health needs assessment identified seven studies reporting the prevalence of neck pain. Figures ranged from 5,000 to 20,000 per 100,000 population with most estimates a round 10,000. They concluded that in a PCT population of 100 000 people there would be about 5000 cases.(11)

Whiplash 3.54

Whiplash describes a type of neck injury caused by sudden acceleration then deceleration of the head resulting in spraining of the neck ligaments. It most commonly occurs as a result of a road traffic accident, usually a collision from behind.

Chronic Pain Health Needs Assessment

3.55

The Association of British Insurers states that 570,000 claims are made a year for whiplash injuries in the UK, an incidence rate of approximately 900 per 100,000 population.(47) This figure will be exaggerated by the inclusion of fraudulent claims. In a 2002 paper Galasko estimates the number of new cases per year in the UK at 250,000 or 400 per 100,000 population.(48)

3.56

A study of whiplash attendances to an emergency department in Southampton found that 1 in 125 new patients had a whiplash associated disorder (WAD) following a road traffic accident (RTA), and that two thirds of these are likely to have some degree of disability four to six weeks after injury. Just over half of all the RTA attendances met the inclusion criteria for WAD.(49)

3.57

In a previous study Galasko et al reported 46% patients attending an emergency department following injuries sustained in an RTA, were diagnosed with neck sprain.(50)

Osteoarthritis

3.58

Osteoarthritis is an inflammatory disease of the joints that results from the degeneration of cartilage. It is the most common form of arthritis and commonly affects the hands, feet, spine, hips and/or knees. Primary osteoarthritis is mostly the result of aging. Secondary osteoarthritis may also occur as a consequence of other disease or conditions such as obesity, congenital abnormalities, gout and diabetes.

3.59

It is difficult to determine the exact incidence and prevalence of OA as the structural changes, usually identified by radiography, do not always correspond with the clinical syndrome of joint pain and stiffness. The clinical syndrome is more common than radiographically confirmed osteoarthritis and much radiographic osteoarthritis occurs in the absence of symptoms. For the purposes of a chronic pain health needs assessment it is the clinical syndrome that is of relevance.

3.60

Parsons et al have undertaken a review of studies on incidence and prevalence for a number of musculoskeletal conditions including osteoarthritis.(22) They found incidence figures reported by the Royal College of General Practitioners Research Surveillance Centre and the General Practice Research Database. The RCGP RSC reported incidence rates of patients consulting for the first time with GP diagnosed OA. In 2001, the rate was 700 per 100,000 men and 1,200 per 100,000 women. Incidence increased with age, peaking in the 75+ age group (2,900 per 100,000 men and 3,600 per 100,000 women). Incidence was higher among women than men in all age groups over 25 years. The GPRD found the annual incidence of OA to be 1,290 per 100,000 in men and 1,860 per 100,000 among women aged 40 or over. The same source data sets also provided estimates of period prevalence. The RCGP RSC reported an annual consulting prevalence in 2001 of 1,800 per 100,000 men and 3,200 per 100,000 women. The GPRD data was used to calculate agestandardised prevalence rates of 1,200 per 100,000 men and 2,000 per 100,000 women.

3.61

The GP-based prevalence figures from the RCGP RSC and the GPRD are much lower than those reported in population-based surveys. This suggests that many people with OA do not consult their GPs.

Chronic Pain Health Needs Assessment

3.62

In a 2012 review Suri et al report symptomatic prevalence figures for osteoarthritis from two studies set in the US. The prevalence in the over 45s for osteoarthritis of the knee ranged rom 7 to 17%; in the hip 10%; and in the hand 11%.(51)

3.63

A Canadian study using routine administrative health data for British Columbia found a point all-age prevalence of OA of 10.8% (8.9% for men and 12.6% for women). Prevalence increased with age from around 10% in 45-49 year olds to over a third in those age d 70-74 years. The overall incidence rate of new cases was reported as 1,170 per 100,000 (1,000 in men and 1340 in women).(52)

Rheumatoid Arthritis 3.64

Early figures for rheumatoid arthritis prevalence were published in 1961 for a study in Leigh and Wenslydale. It reported a population prevalence of 1.1%.(53) More recent figures have been published by the Norfolk Arthritis Register based on primary care consultations. In 1990 this register reported an annual incidence of new cases of RA of 27 per 100,000 men, and 56 per 100,000 women.(54) The same register has also been used to produce adult prevalence estimates extrapolated to the UK of 0.8% (0.4% among men and 1.1% among women). The prevalence was higher among women than men for all groups.(55)

3.65

Similar figures were produced by the RCGP RSC for the year 2001 with one year period prevalence for primary care consultation for RA of 0.2% among men and 0.6% among women.(22)

Psoriatic arthritis 3.66

Psoratic arthritis is a type of inflammatory arthritis that occurs in patients with psoriasis. It causes pain and swelling in the joints and may also affect tendons and ligaments.

3.67

The Norfolk Arthritis Register provides an estimate of psoriatic arthritis incidence for the UK. In 1990-93 it reported an age adjusted incidence of 3.5 per 100,000 in adult males and 3.4 per 100,000 in adult females. Cases were defined as co-occurring psoriasis and peripheral inflammatory polyarthritis.(56)

3.68

A study in Minnesota estimated the age and sex adjusted annual incidence of psoriatic arthritis among adults to be 7.2 per 100,000 (9.1 per 100,000 in men and 5.4 per 100,000 in women).(57) A 2007 review by Cimmino reported incidence from four of studies in the USA and Europe with rates ranging from 3 to 23 per 100,000.(58)

3.69

In the Minnesota study, the point prevalence of PsA in adults in 2000 was reported as 158 per 100,000 (193 per 100,000 men and 127 per 100,000 women).(59) Cimminoâ&#x20AC;&#x2122;s review also included prevalence figures and reported point prevalence figures from six studies in Europe and the USA ranging from 0.06% to 0.42%.(58)

Polymyalgia rheumatic 3.70

Polymyalgia rheumatic is an inflammatory condition that causes pain and stiffness in the shoulders, neck and pelvis. Other systemic symptoms include lethargy, weight loss and depression.

Chronic Pain Health Needs Assessment

3.71

A 2008 review of the disease in the BMJ characterised its epidemiology as follows:(60)  The incidence of the disease in patients aged over 50 is about 100 per 100,000.  The average age of onset is just over 70 years of age. It is seldom diagnosed in

people younger than 50 years of age.  Polymyalgia rheumatica (PMR) is seen mainly in people of north European ancestry,

although it can occur in any ethnic group.  Women are more frequently affected than men with a female:male ratio of

approximately 3:1. 3.72

Defining a prevalent case of PMR is difficult, as the disease may be completely suppressed by successful treatment with steroids. This may help to explain McQuay et al’s finding that prevalence figures found in their review varied greatly, ranging from 30 per 100,000 to 2,000 per 100,000.(11)

3.73

Parson et al’s review reported prevalence figures from a UK community based study of 1,090 per 100,000 persons aged over 50 years; and annual period consultation prevalence rates from the RCGP RSC of 140 per 100,000 men and 311 per 100,000 women.(22)

3.74

For their health needs assessment McQuay et al estimated an incidence rate of 50 per 100,000 person years and a point prevalence of 500 per 100,000 persons in a typical PCT population. (11)

Chronic Widespread Pain (CWP) and Fibromyalgia

3.75

Chronic widespread pain (CWP) is a musculoskeletal disorder characterised by fatigue and widespread chronic pain in the muscles and fibrous tissues of the body which can be described as burning, throbbing, shooting, or stabbing. The cause is uncertain and there is currently no generally accepted cure. The term fibromyalgia is often used as a pseudonym but which in strict definition terms is a sub-set of CWP. The American College of Rheumatology (ACR) diagnosis criteria used for fibromyalgia requires the presence on examination of at least 11 of 18 specific tender points. Only about 20% of patients with chronic widespread pain will meet these criteria, the remaining 80% are likely to have pain that is similarly ‘central’ in nature, i.e. pain that is not due to inflammation or trauma.(61)

3.76

Parsons et al reviewed three UK studies looking at the prevalence of CWP in adults. The point prevalence figures ranged from 7.9 to 9.4% in men and 10.5 to 15.6% in women. They found no recent UK figures for the prevalence of fibromyalgia but did report two North American studies with figures of 0.5% and 1.6% for men and 3.4% and 4.9% in women.(22)

3.77

A single study was reported that investigated the incidence of GP-diagnosed fibromyalgia based on data from the GPRD. The consulting incidence of fibromyalgia in 2001 was estimated to be 35 per 100,000 person years. The incidence was reported to be 4 times higher in women than in men.(62) CWP and fibromyalgia can occur at any age but peak incidence and prevalence occurs around 50-64 years.(22,63)

Chronic Pain Health Needs Assessment

3.78

McQuay et al estimate that in a primary care trust population of 100 000 people there would be about 10,000 cases of chronic widespread pain, with about 200 to1000 of those being defined as fibromyalgia.(11)

Knee pain 3.79

In older age groups osteoarthritis is responsible for most cases of knee pain but as discussed above the epidemiology of joint pain and radiologically confirmed OA is not the same. Parsons et al identified four studies of the prevalence of knee pain using GP populations as the sampling frame. Figures reported include a point prevalence of 28.7% of 40-79 year olds in Nottingham, and 19% of over 18s in the south east; a one month prevalence of 19% of over 16s in Tameside; and one year period prevalence of 51% of over 50s in Staffordshire.(22,64)

3.80

A review by Peat et al identified five studies in England measuring the prevalence of knee pain in older adults (various definitions but minimum age was 40 years) with figures ranging from 13% to 28%.(65)

Shoulder pain 3.81

The prevalence of shoulder pain in the adult population is high. The Parson et al review reports figures of 7–20% from population based surveys. Surveys in Tameside, Manchester and South East England all reported prevalence rates of 14% in men and 17% in women.(22)

3.82

A UK study using the IMS primary care consultation database, reported an incidence rate of 1.47% for adults aged over 18 for all shoulder conditions (1.45% for men, 1.49% for women). The same study recorded a prevalence of 2.36% (2.28% for men, 2.43% for women). Only 17% of these shoulder conditions were coded as ‘shoulder joint pain’ or ‘arthralgia – shoulder’, corresponding to a prevalence of 0.24%. Comparison to the population survey based figures suggests that many people suffering shoulder pain do not consult their GPs.

Medically unexplained pain syndromes (MUPS) [Query Overlap with musculo-skeletal symptoms particularly CWP / fibromyalgia] 3.83

There is very little literature on the incidence and prevalence of medically unexplained pain as a distinct condition. Two Dutch have attempted to quantify the presentation of such symptoms in general practice. Verhaak et al looked at the consultations for medically unexplained physical conditions, including a ‘cluster’ of pain conditions. Between 25 to 50% of all the GP consultations were medically unexplained but they included as cases only those that had a persistent condition, defined by presenting at least 4 times during the year of the study. Of all patients over 18 years of age who consulted with a GP during the year, 2.45% had persistent medically unexplained physical symptoms, nearly half of these (1.2%) had symptoms in the pain cluster.(66)

3.84

The aim of the second study by Kerssens et al was to estimate the prevalence of unexplained severe chronic pain (USCP) in general practice. Patients were included if they were aged between 18 and 75 years; and had pain which had lasted at least 6 months, was

Chronic Pain Health Needs Assessment

the most prominent aspect in the clinical presentation, was serious enough to justify clinical attention, and had led to obvious discomfort and disability in their daily life for at least for 1 month. The overall prevalence was 7.91 per 1000 enlisted patients, ranging from 1.87 in the youngest to 13.50 in the oldest patients.(67) Face/head Migraine 3.85

The reported prevalence rates for migraine vary greatly and depend largely on the case definition used and age and sex structure of the study population. McQuay et al report prevalence figures of 5 to 8% of men and 14 to 22% of women in a review of 10 studies.(11)

3.86

Rates were highest for both men and women in the 30-45 age group. The findings are consistent with those reported in a meta-analysis of 18 studies of all ages and from all countries.(68) Only about one in five or six people who suffer from migraine will seek medical care.(69)

3.87

McQuay et al estimate that a primary care trust of 100 000 people will have about 10 000 women and 2000 men who suffer from migraine.(11)

Headache 3.88

Tension type headaches are the most common form of headache. McQuay et al identified 5 studies of chronic tension type headache â&#x20AC;&#x201C;i.e. where a tension type headache occurs on 15 or more days per month. All of the studies used validated methods such as clinical examination, telephone interview or self-assessed questionnaires. Four of these studies reported one-year prevalence figures of between 1 and 3%, with higher rates in women than in men.(11)

3.89

Cluster headaches are rare, extremely painful and debilitating headaches that occur in groups or clusters. A review of the limited epidemiological studies by Torelli et al identified 5 studies with prevalence rates ranging from 56 to 326 per 100,000. There own study in Parma reported a rate of 279 per 100,000 population aged over 14 years (338 per 100,000 men and 227 per 100,000 women).(70)

Trigeminal neuralgia

3.90

Trigeminal neuralgia is rare and there are very few epidemiological studies reporting its incidence or prevalence. A Minnesota study reported an annual incidence rate of a first episode of trigeminal neuralgia of 4.7 per 100,000 (3.4 per 100,000men and 5.9 per 100,000 women). The incidence rate rose with age with a peak in the 50-70 years age group. The authors estimated a prevalence rate for current or recent attack in the 50-70 year age group of 400 per 100,000.(71)

3.91

A large study in Carlisle in the 1950s reported an incidence rate of 2.1 per 100,000 but the authors noted that this was likely to be an underestimate as data from local ENT hospitals were not included.(72)

Chronic Pain Health Needs Assessment

Neuropathic pain 3.92

The overall prevalence of neuropathic pain in the general population is difficult to quantify, due to the large number of underlying causes and the lack of standardised measurement methods. However, two surveys suggest a prevalence rate of 6-8% of the general population report chronic neuropathic pain.(73,74)

3.93

It has been estimated that half of such patients will require medication and regular support to manage their pain.(75)

3.94

A study of primary care records from the Netherlands estimated the annual incidence of neuropathic pain in the general population to be almost 1%.(76)

Diabetic neuropathy 3.95

In a community-based study from northwest England of 15,692 patients with diabetes, the prevalence of clinical neuropathy was 49%, the prevalence of painful neuropathic symptoms was 34% and the prevalence of painful neuropathy symptoms accompanied by clinical neuropathy was 21%. The risk of painful neuropathy was increased in patients with type 2 diabetes, women, and those of South Asian ethnicity.(77) studies have estimated the prevalence of painful diabetic neuropathy in persons with diabetes to be between 16% and 26%.(78,79,80)

3.96

The prevalence of diabetes in England in 2011 was 5.5%.(81) From these figures we estimates that in a typical PCT population of 100,000 there are in the region of 5,500 people with diabetes, of whom approximately 1,850 have painful neuropathic symptoms and of those 1,100 have clinical diabetic neuropathy.

3.97

Hall and colleagues have undertaken two studies of the incidence of painful diabetic neuropathy using similar methods but two different UK primary care databases. They reported incidence rates of 15.3 and 26.7 per 100 000 person years.(82,83)

Postherpetic neuralgia 3.98

Studies identified by McQuay et al estimate that Herpes zoster occurs in the general population at a rate of about 340 per 100,000 person years. Postherpetic neuralgia (PHN) is a common complication of herpes zoster, occurring in about 13â&#x20AC;&#x201C;26% of cases. In the studies reviewed, painful neuropathy in over 40% of people with herpes zoster aged over 50 was a common finding.(11)

3.99

A review of neuropathic pain epidemiology studies by Smith et al (84) found incidence figures of 3, 27.3 and 40.2 per 100,000 person years. (85,86,87) A further study reported an incidence rate for primary care consultation for postherpetic neuralgia of 34 per 100,000 person years.(88)

Multiple sclerosis (MS) 3.100 The crude incidence rate of MS in the UK has been estimated at 3.4 per 100,000 person years for men and 7.4 for women.(89)

Chronic Pain Health Needs Assessment

3.101 Based on a review of prevalence studies Richards et al estimated the prevalence rate of MS in England & Wales for 2000 to be between 107 and 117 per 100,000 population.(90) 3.102 McQuay et al reviewed a number of studies examining the prevalence of chronic pain in patients with MS. The definitions of chronic pain differed and but in all studies pain was common, prevalence figures ranged from 29% to 65%.(11) 3.103 Based on the above figures we estimate a typical PCT population of 100,000 people in England or Wales could expect to have about 55 patients with multiple sclerosis and chronic pain and 3 new cases with pain each year. Chronic post-stroke pain 3.104 Estimates of the incidence of stroke from two studies in England varied from 116 to 152 per 100,000 person years for men and from 135 to 171 for women.(91,92) A third study reported a lower incidence of 104 per 100,000 person years for both genders combined.(93) 3.105 Estimates for the prevalence of stroke in England vary depending on the source. Estimates based on GP records suggest an all age prevalence of about 0.7%. (92),(93) Population survey-based and modelled estimates suggest a prevalence figure around 3 times higher at around 2 to 2.5%.(94,95) 3.106 In two studies identified by McQuay et al the prevalence of chronic pain in patients who had had a stroke varied from 2% to 8.4%.(11) 3.107 In a primary care trust of 100 000 people we estimate there could be as many as 40 to 200 people living with chronic post-stroke pain. Complex Regional Pain Syndrome (CRPS) 3.108 Complex regional pain syndrome (CRPS) is a type of chronic limb pain with clinical features that include sensory, sudo- and vasomotor disturbances, trophic changes and impaired motor function. The major characteristics are the presence of pain that is severe, diffuse, non-dermatomal, and associated with allodynia (pain response to a non-painful stimulus). The disease course varies from relatively mild and self-limiting to chronic disease with a high impact on daily functioning and quality of life. CRPS most commonly affects a single limb but involvement of other limbs by a spread of the process from the original affected limb is known to occur. 3.109 The International Association for the Study of Pain divides CRPS into two types based on the presence of nerve lesion following the original injury. ď&#x201A;ˇ Type I, also known as Sudeck's atrophy, reflex sympathetic dystrophy (RSD), reflex

neurovascular dystrophy (RND), or algoneurodystrophy, does not have demonstrable nerve lesions. ď&#x201A;ˇ Type II, also known as causalgia, has evidence of obvious nerve damage. 3.110 Two population based studies have attempted to measure the incidence and prevalence of CRPS in the general population. The first, set in Rochester, Minnesota over the period 1989-99 reported an incidence rate for CRPS I of 5.46 per 100,000 person years.(96) 32

Chronic Pain Health Needs Assessment

Women were much more likely to be affected than men with incidence rates of 8.57 and 2.16 per 100,000 respectively. One-year period prevalence was also reported with a figure of 20.57 per 100,000 population overall and 35.33 and 5.06 for males and females respectively. Onset could occur at any age but the incidence increased to a peak in the 5069 age groups and decreased again thereafter. Incidence and one-year period prevalence rates for CRPS II were found of 0.82 per 100,000 person years and 4.2 per 100,000 persons respectively with no significant difference observed between genders. The study also found that 74% of the CRPS cases underwent resolution, often spontaneously. 3.111 The second, more recent study was undertaken in the Netherlands over the period 19962005 using a primary care research database. (97) The estimated overall incidence rate of CRPS was over four times higher than the American study at 26.2 per 100,000 person years. Females were affected at least three times more often than males (ratio: 3.4). The highest incidence occurred in the 61-70 years age group. The study did not report prevalence. Vascular pain 3.112 There is substantial information on the incidence and prevalence of cardiovascular disease due to its high mortality and morbidity. There is limited information about the incidence and prevalence of painful symptoms associated with these conditions. Intermittent claudication 3.113 Population studies have found that about 20% of people aged over 60 years have some degree of PAD, and the most common initial symptom is pain in the leg on walking known as intermittent claudication.(98) 3.114 A Dutch study of the prevalence of intermittent claudication reported a point prevalence in an over 55 years population of 1.6% (2.2% of men and 1.2% of women). The same study undertook a review of a further 13 population based surveys for similar age groups with figures of the order of 1 to 2%.(99) A further Dutch study estimated the incidence rate of IC as 640 per 100,000 person years in the over 55s.(100) The Framingham Heart Study in Massachusetts reported a lower incidence of 225 per 100,000 person years in those aged over 40 during the 1990s.(101) 3.115

A typical primary care trust of 100 000 people might expect to have 529 400–800 people with intermittent claudication, and see 100-180 new cases a year.

Raynaud’s phenomenon 3.116 McQuay et als health needs assessment identified four population studies measuring the prevalence of Raynaud’s phenomenon. The figures ranged from 2% to 15% but depended to a large extent on the disease definition used.(11) 3.117 An additional 7-year study of Raynaud’s phenomenon based on the Framington Heart Study in Massachusetts showed baseline prevalence rates of 11% in women and 8% in men.(102)

Chronic Pain Health Needs Assessment

3.118 We estimate a typical PCT population of 100,00 might expect to have of the order of 1,800 to 13,000 people with Raynaudâ&#x20AC;&#x2122;s phenomenon but cannot quantify how many of these will be suffering from chronic pain. Angina 3.119 The British Heart Foundation (BHF) report lifetime prevalence (having ever been diagnosed with) angina in England 2009 based on data from the GPRD.(94) Male prevalence increases from 0.1% in 0-44 year olds to 16.7% in the over 75s with an all age prevalence of 2.0%. Female prevalence increases from 0.1% in 0-44 year olds to 11.5% in the over 75s with an all age prevalence of 21.2%. These GP-based prevalence figures are lower than those reported by population surveys. The Health Survey for England 2006 reports lifetime prevalence rates in males from 0.1% in 16-24 year olds to 22.7% in the over 75s with an all age proportion of 4.8%. For females, proportions increase from 0.1% in the 16-24 year olds to 15.9% in the over 75s, with an all age figure of 3.3%.(103) 3.120 McQuay et al identified 4 population survey based studies which provide reliable prevalence estimates for angina in the UK and estimated a figure of 5% in all adults.(11) 3.121 The BHF also report incidence rates for angina in England 2009 based on the same GPRD source. Male rates increase from 54 per 100,000 person years in the 45-54 age group to 194 in the 65-74 year olds. Female rates are lower and increase from 30 per 100,000 person years in the 45-54 age group to 128 in the 65-74 year olds. All age incidence rates are 45 per 100,000 person years for men and 25 for women. These incidence rates appear low compared to the prevalence levels reported. 3.122 Neither of the above measures reported above lifetime prevalence or incidence of angina provide information that readily quantifies the expected need for chronic pain services related to angina. 3.123 A primary care trust with a population of 100 000 might expect to have about 4000 people who have or have had angina.

Chronic postoperative pain 3.124 The lack of an accepted definition for chronic postoperative pain is a major barrier for quantifying its incidence and/or prevalence from the literature. Poor study design and variations in the definitions of time after surgery, severity of pain, and its effect on quality of life and function are largely responsible for the wide range in the published incidence figures for given procedures. However it is clear from the scale of the estimates that chronic postoperative pain is a significant problem. The best estimates for chronic pain following major surgery are of the order of 10 to 50% of which between 2 to 10% are likely to be severe.(104) 3.125 In most affected patients, postoperative chronic pain closely resembles neuropathic pain. Major nerves trespass the surgical field of most of the surgical procedures associated with chronic pain, and damage to these nerves is probably a prerequisite for the development of postoperative chronic pain. In a subset of patients, a continuous inflammatory

Chronic Pain Health Needs Assessment

response, such as after inguinal mesh hernia repair, can contribute to a maintained inflammatory pain. Differentiation of neuropathic from non-neuropathic causes of postsurgical pain is essential for the design of effective strategies to prevent and treat the conditions. 3.126 Table 6 summarises the incidence estimates for selected surgical procedures from a number of reviews and studies. In his review Macrae estimated a total incidence of new cases of postoperative chronic pain for his included procedures to be between 41,000 and 103,000 in the UK, based on the number of procedures being undertaken.(105)This is equivalent to 65 to 165 new cases per 100,000 population. Pain after amputation (phantom limb pain) 3.127 The reviews suggest anywhere from 10% to 85% of patients undergoing an amputation will suffer from chronic postoperative pain. 3.128 McQuay et alâ&#x20AC;&#x2122;s health needs assessment differentiates estimates for phantom limb pain and stump pain. They reported phantom limb pain occurring in half to three-quarters of amputees and that the pain can continue to persist long after the surgery (7 years). In one study 7.5% experienced constant pain in the phantom limb. Studies on stump pain reported rates of chronic pain from 49% to 62%.(11) 3.129 From data from a Dutch and a Finnish study McQuay et al estimates a prevalence of 25 amputees in a typical PCT population of 100,000 most of whom will have phantom limb and/or stump pain. 3.130 A UK primary care based study has reported an incidence rate of 0.8 per 100,000 person years for phantom limb pain.(106) Chronic postoperative breast pain 3.131 McQuay et al reviewed 8 studies reporting the occurrence of chronic pain after breast surgery. There was some variation because of time after surgery and whether the definition included lumpectomy or only full mastectomy, but typically 20 to 50% of patients reported chronic pain. Between 5 and 10% reported severe disabling pain.(11) A wider range for chronic pain prevalence of 13 to 69% was reported by a second review.(107) 3.132 Despite changes in surgical practice that have reduced the number of radical mastectomies and replaced them with less invasive techniques the rate of chronic postoperative pain remains high. A 2007 study of sentinel lymph node biopsy or axillary lymph node dissection reported a prevalence of 22% and 55% respectively for numbness at 5 years after surgery. (108) Chronic postoperative thoracotomy pain 3.133 Chronic pain after thoracotomy was common occurring in 5 to 65% of patients. Estimates for the occurrence of severe pain ranged from 10% to 15% to 25%.(11,109) It is difficult to quantify the number of thoracotomy procedures performed in England as the routine HES

Chronic Pain Health Needs Assessment

statistics report on the main procedure in an episode. Thoracotomy is unlikely to be recorded as the main procedure. Chronic postoperative cholecystectomy pain 3.134 McQuay et al reported two prospective studies investigating the occurrence of chronic scar pain following open cholecystectomy. At 12 months occurrence of chronic pain at the incision site was 27%, and at 24 months 21%. Two further studies attempted to compare the occurrence of chronic pain after between open and laparoscopic cholecystectomy. Stiff et al. reported a occurrence of 3.4% after laparoscopic compared with 9.7% after open procedure. Wilson and Macintyre found a similar occurrence of 7% in both groups.(110,111) Other postoperative pain 3.135 Poobalan et al’s review of pain following inguinal hernia repair concluded that 30% of patients report chronic pain of which a third (10%) are moderate to severe. The reported pain was predominantly neuropathic in character.(112) A second inguinal hernia review by Aasvang and Kehlet estimated 12% of patients will suffer from chronic postoperative pain.(113) 3.136 Studies investigating postoperative pain following orthopaedic surgery have reported an incidence of chronic pain between 8 and 28% for hip replacement with pain limiting daily activities to a moderate, severe or very severe degree in 12.1%.(114,115) An incidence of 35% has been reported for knee replacement.(116) 3.137 There have been very few studies of chronic pain following minor orthopaedic surgery. One study in France has reported chronic postoperative pain incidence of 22% in patients undergoing surgery for Carpal Tunnel Syndrome, a rate similar to those reported above for major surgeries.(117)

Table 6: Estimated incidence of chronic postoperative pain and disability after selected surgical procedures Procedure

Kehlet 2006 (118)

Macrae 2008 (120)

McQuay 2007 (11)

Selected Other (121,122, 123)

Main procedure episodes England 2011/12 (124,125)

Chronic pain

Severe (disabling) pain

Amputation

30-50%

5-10%

30-85%

50–85%

51-85%

15,000

Breast surgery (lumpectomy and mastectomy) Thoracotomy

20-30%

5-10%

11-57%

20–50%

25-50%

58,000

30-40%

10%

5-67%

5–65%

14-67%

3-56%

5–50%

3-27%

0-63%

5–35%

Cholecystectomy Inguinal hernia repair

NHS QI Scotland 2006 (119)

10%

2-4%

69,000 30%

81,000

Chronic Pain Health Needs Assessment

Caesarean section

10%

Cardiac surgery Coronary artery bypass surgery Hip replacement

30-50%

166,000

30â&#x20AC;&#x201C;55%

41,000

5-10%

Knee replacement

20,000 12%

8-22%

83,000

35%

79,000

THE NATURAL HISTORY OF CHRONIC PAIN 3.138 Chronic pain is not yet formally recognised as a separate disease entity and therefore not recorded as such. Clinical data systems record the underlying disease and therefore there is not much readily available information on the course of chronic pain over time. There is therefore a paucity of good data on which to base robust conclusions about the natural history of chronic pain. Research studies too are scarce since chronic pain is a field that has only recently been opened up to epidemiological investigations. 3.139 One of the few good follow-up studies is that by Elliott(126), who reported a 4 year followup study based on the original cohort that was assembled in 1996 for their prevalence study reported earlier(127). They achieved a response rate of 83% of the original respondents. 79% of those with chronic pain at baseline still had it at follow-up with an average annual recovery rate of 5.4%. Older people (aged 45-74) with chronic pain were less likely to recover than those aged 25-34. 3.140 The course of chronic widespread pain (CWP) has been reported in a follow-up study from Manchester(128). A postal survey was carried out of 2334 adults registered with 2 general practices and repeated again 7 years later with those of the initial responders who were still registered with the same practices. While CWP prevalence was broadly similar on both occasions (11% and 10% respectively), the interesting finding was of the persistence of CWP. Of those with CWP initially, a third recorded CWP on the follow-up survey, while only 2% of subjects with no initial pain recorded CWP on the subsequent survey. Age was an important factor in the persistence of CWP. Among subjects with CWP in the initial survey who were aged over 50, 77% reported CWP 7 years later. Pain once established is likely to persist or recur and older age appears to be a risk factor. 3.141

In a one year follow-up study of subjects with CWP identified in a survey of people sampled from a population-based register, researchers from the same unit in Manchester found that CWP persisted in 56% of patients at 1 year. This is a useful finding since the impression gained from clinic based cohorts is that the persistence of pain is much more frequent. Persistence of pain symptoms was also found to be associated with a pattern of illness behaviour characterised by frequent visits to the doctor and high baseline test scores for psychological distress and fatigue.

Chronic Pain Health Needs Assessment

4 THE ECONOMIC COSTS OF CHRONIC PAIN 4.1

The CMO report of 2008(2) reported a figure of £12.3 billion as the total cost of back pain alone. This figure included not only the direct costs of investigating and treating the underlying disease and the pain itself but also the indirect costs incurred due to lost productivity arising from sickness absence, compensation payments, and welfare benefits. Of the direct costs of chronic pain, prescriptions of pain relieving drugs account for an expenditure of £584 million each year.

4.2

Phillips(129) provides a concise summary of the available research from different countries into the economic impacts of pain. For the UK, the indirect (lost productivity) cost of back pain was estimated to be between £5 billion and £10.7 billion in 1998 depending on the assumptions made.

4.3

The link between a health related problem and employment was explored exhaustively in the report by Dame Carol Black(130). Back pain is the fourth most common cause of short duration sickness absence (up to one week), after colds, flu and diarrhoea and sickness. Back pain and other pain related ‘problems with joints or muscles’ each accounted for 10% of absences of between 1 and 4 weeks.

4.4

A clear distinction is necessary between painful conditions (injury, joint and muscle pain, low back pain) and chronic pain. Specialist pain services see the most severe cases of chronic pain; these are difficult to treat and rehabilitate and so they may have the impression that a return to work is not the norm. However, more systematic studies show that 85% of those off work due to musculoskeletal injuries and 83% of those with back pain actually return to work after and absence of 4 weeks or more.

4.5

Of the 4 leading causes of long term sickness absence, two (musculo-skeletal conditions, and back pain) are related to chronic pain. The other two are stress/anxiety/depression, and cancer-related illnesses, where too there may be an overlay of pain as a leading cause of loss of functional ability.

NHS EXPENDITURE ON CHRONIC PAIN

4.6

The Department of Health’s Programme Budget project provides a source of information on where the NHS is spending its budget. Since 2003/4 annual data have been supplied by Primary Care Trusts detailing their expenditure by specific healthcare conditions or categories. The programme budgeting collection for 2010/11 comprised 23 categories, most of which are based on the World Health Organization’s International Classification of Disease version 10 chapter headings. Examples include: Cancers & Tumours, Mental Health Disorders, and Problems of Circulation. Each of the categories is further divided down into more specific sub-categories. Budgets spent on chronic pain are assigned to the category 7-Neurological Problems and the sub-category 7A-Chronic Pain.

4.7

In addition the data set for 2010/11 also saw the introduction, for the first time, of a breakdown of the programme budget category data by 12 care settings.(131) These settings are described in Table 7.

Chronic Pain Health Needs Assessment

Table 7: Programme Budget care settings Care setting name Prevention & health promotion

Primary care

Primary prescribing Inpatient: Elective & Daycase Inpatient: Non-elective Outpatient Other secondary care

Ambulance A&E Community care

Care provided in other setting

Non health / social care

Description Primary & secondary prevention, health promotion, family planning, school health services, national screening programmes, public health programmes for communicable and non-communicable disease, epidemiological surveillance and public health administration. Primary care costs relating to services provided by GPs, primary dental services and primary ophthalmic services excluding those which relate to prevention/health promotion. Primary care activity relating to prescribing or pharmaceutical services, excluding those which relate to prevention/health promotion. Admitted patient care activity which takes place in a hospital setting where the admission was elective or as a day-case. Admitted patient care activity which takes place in a hospital setting where the admission was as an emergency/non-elective. Outpatient attendances or procedures. Activity included with this setting will include direct access services, unbundled services (excluding critical care) and secondary care services which cannot be allocated to more specific settings. Mental Health secondary care services should also be included within this care setting. Urgent and emergency transport, i.e. Ambulance activity and 111 expenditure. All activity which takes place within A&E departments and minor injury units. Care delivered outside of a hospital and within local communities. Inpatient and outpatient activity carried out within community hospitals should be classified as secondary care activity. All other activity carried out in community hospitals should be classified as community care. All other health and social care services which are not included within the other health settings. Includes prison healthcare, nursing homes, hospice care. Continuing care, intermediate care, respite care, free nursing care should be included within this setting. Social care and learning disability services should be included within this setting unless otherwise specified by the mappings. Expenditure which is not related to the commissioning or provision of health/social care services (e.g. costs relating to facilities & estates).

4.8

Mapping activity and budget data to programme budget categories and care settings is a detailed process. Guidance documentation is provided to PCTs by the Department of Health (131) and PCTs are encouraged to adhere to the outlined mappings even where local knowledge may enable more accurate allocations. If uniform allocation is achieved then variation of expenditure between PCTs is less likely to reflect coding and calculation differences.

4.9

Spend and activity mapping to sub-category 7A-Chronic Pain for the main care settings of primary prescribing, outpatient and inpatient settings data are outlined below:

Primary prescribing

Chronic Pain Health Needs Assessment

4.10

The mapping of the spend on drugs prescribed in primary care to Programme Budget subcategory is not undertaken at the patient or script level, i.e. it is not possible to assign individual scripts to a sub-category based on the indication for which it was written. Instead, British National Formulary classifications are used to map the total PCT spend on each type of drug to the sub-categories. Where drugs have indications from across more than one sub-category, the expenditure is allocated to those categories on a defined split basis.

4.11

Table 8 lists those drugs from BNF classification section 4.7 – Central Nervous system: Analgesics that are allocated to 7A–Chronic pain, together with their splits.

Table 8: Primary care prescribing – drugs mapped to Programme Budgeting sub-category 7AChronic Pain BNF Section

Sub-section

Chemical substance

4 Central nervous system 4.7: Analgesics 4.7.1 Non-opioid analgesics 4.7.2 Opioid analgesics

Buprenorphine Codeine phosphate Dihydrocodeine tartrate Tramadol hydrochloride

4.7.3 Neuropathic pain

Programme Budget Subcategory (% split) 7A/15X/16X (5:75:20) 7A/2X (50:50) 7A/13B/15X/16X (50:5:35:10) 7A/15X/16X (50:40:10) 7A/15X/16X (50:40:10) 7A

Source: Programme Budgeting mappings and definitions, Department of Health.(132)

4.12

The spend on primary care prescribed drugs for chronic pain includes 5% of all non-opioid analgesics; 50% of the opioid analgesics buprenorphine, codeine phosphate, dihydrocodeine tartrate and tramadol hydrochloride; and all neuropathic pain drugs (though many of these preparations share additional indications).

Outpatients - attendances 4.13 Outpatient activity is mapped to Programme Budgeting sub-category at the level of individual attendance based on its treatment function code (clinic or specialty code). Two treatment function codes are mapped to 7A Chronic Pain and these are 191 Pain Management and 241 Paediatric Pain Management. 4.14

Mandatory national tariffs apply for Pain Management attendances as outlined in Table 9. The actual local tariff will include a local market forces factor. Paediatric Pain Management

Chronic Pain Health Needs Assessment

attendances are excluded from the national tariffs and prices are agreed locally. Table 9: Pain Management outpatient attendance tariffs Attendance type First Attendance - Single Professional

2010/11 £ 160

2011/12 £ 156

First Attendance - Multi Professional 231 220 Follow Up Attendance - Single Professional 84 83 Follow Up Attendance - Multi Professional 95 98 Source: NHS Payment by Results 2010-11 National Tariff Information, Department of Health.(133)

Outpatients - Procedures 4.15 Spends associated with certain procedures performed in outpatients are also mapped to Programme Budget sub-categories. These are assigned at the individual activity level based on the Health Resource Group (HRG) code to which the procedure is mapped. There are 2 HRG codes mapped to 7A-Chronic Pain: 4.16

AB05Z - Intermediate Pain Procedures

4.17

AB06Z - Minor Pain Procedures

4.18

The procedures that are mapped to these two HRG codes are listed in appendix I.

4.19

Both of these HRG codes are allocated a cost of £202 (FY 2010/11) and £229 (FY2011/12) within the national tariff. (133)

Inpatient spells 4.20 Inpatient activity is mapped to Programme Budgeting sub-category at the level of individual spell based on the spell’s primary diagnosis code. There are 90 ICD10 diagnosis codes identified by the guidance that are mapped to 07A Chronic Pain (Table 10).(132) Unlike for outpatient activity, it is not possible to provide a simple list of costs associated with the inpatient spells that are assigned to Chronic Pain. The cost of each spell is assigned according to the spell’s HRG code and whether the activity was undertaken as an elective or emergency admission. HRG codes are assigned primarily on the basis of the procedure(s) undertaken, and not on the diagnosis. Consequently there is no direct mapping of HRG and associated cost to programme budgeting categories. 4.21

There are a number of HRG codes that relate specifically to the care of pain and the tariffs for these give an idea of the cost involved in individual treatments. Not all of the activity assigned with these HRG codes will be assigned to Chronic Pain Programme Budget subcategory (e.g. some might be assigned to 15-Problems of the musculoskeletal system or 04A Diabetes) but a significant proportion of the Chronic Pain sub-category is likely to consist of these HRG codes. The codes and their associated costs are given in Table 11. [Are these HRGs likely to be used in the management of Acute Pain?]. For example, in 2011/12, a complex major pain procedure carries a tariff of £708 for a daycase/elective admission and £5,025 for a non-elective admission. For both elective and non-elective

Chronic Pain Health Needs Assessment

admissions for this HRG, a trim point of 5 days is assigned after which a further ÂŁ227 per day is costed. (133)

Table 10: Inpatient primary diagnosis codes mapped to Programme Budget sub-category 07A Chronic Pain ICD10

ICD Text

ICD10

ICD Text

B330 G440

Epidemic myalgia Cluster headache syndrome

G636 G638

G441 G442 G443 G444 G448 G500 G501 G521 G546 G564 G570 G571 G572 G573 G574 G575 G576 G578 G579 G580 G587 G588 G589 G600 G601 G602 G603 G608 G609 G610 G611 G618 G619 G620 G621 G622

Vascular headache Tension-type headache Chronic post-traumatic headache Drug-induced headache Other specified headache syndromes Trigeminal neuralgia Atypical facial pain Disorders of glossopharyngeal nerve Phantom limb syndrome with pain Causalgia Lesion of sciatic nerve Meralgia paraesthetica Lesion of femoral nerve Lesion of lateral popliteal nerve Lesion of medial popliteal nerve Tarsal tunnel syndrome Lesion of plantar nerve Other mononeuropathies of lower limb Mononeuropathy of lower limb Intercostal neuropathy Mononeuritis multiplex Other specified mononeuropathies Mononeuropathy Hereditary motor and sensory neuropathy Refsum's disease Neuropathy in association with hereditary ataxia Idiopathic progressive neuropathy Other hereditary and idiopathic neuropathies Hereditary and idiopathic neuropathy Guillain-Barrâ&#x20AC;° syndrome Serum neuropathy Other inflammatory polyneuropathies Inflammatory polyneuropathy Drug-induced polyneuropathy Alcoholic polyneuropathy Polyneuropathy due to other toxic agents

G64X H571 H920 K146 M255 M315 M353 M541 M542 M543 M544 M545 M546 M548 M549 M774 M791 M792 M796 M913 N644 N940 R070 R071 R072 R073 R074 R101 R102 R103 R104 R200 R201 R202 R203 R208

G628 G629 G630

Other specified polyneuropathies Polyneuropathy Polyneuropathy in infectious and parasitic diseases EC Diabetic polyneuropathy Polyneuropathy in other endocrine and metabolic diseases Polyneuropathy in nutritional deficiency Polyneuropathy in systemic connective tissue disorders

R300 R309 R51X

Polyneuropathy in other musculoskeletal disorders Polyneuropathy in other diseases classified elsewhere Other disorders of peripheral nervous system Ocular pain Otalgia Glossodynia Pain in joint-Site unspec Giant cell arteritis with polymyalgia rheumatica Polymyalgia rheumatica Radiculopathy-Site unspe Cervicalgia-Site unspe Sciatica-Site unspe Lumbago with sciatica-Site unspe Low back pain-Site unspe Pain in thoracic spine-Site unspe Other dorsalgia-Site unspe Dorsalgia Metatarsalgia-Site unspec Myalgia-Site unspec Neuralgia and neuritis Pain in limb-Site unspec Pseudocoxalgia-Site unspec Mastodynia Mittelschmerz Pain in throat Chest pain on breathing Precordial pain Other chest pain Chest pain Pain localized to upper abdomen Pelvic and perineal pain Pain localized to other parts of lower abdomen Other and unspecified abdominal pain Anaesthesia of skin Hypoaesthesia of skin Paraesthesia of skin Hyperaesthesia Other and unspecified disturbances of skin sensation Dysuria Painful micturition Headache

R520 R521

Acute pain Chronic intractable pain

R522 R529

Other chronic pain Pain

G632 G633 G634 G635

Source: Programme Budgeting mappings and definitions, Department of Health.(132)

Chronic Pain Health Needs Assessment

4.22

One clear characteristic of the tariffs is the difference between elective and non-elective costs. For the 2011/12 financial year the non-elective costs are between 2 and 7 times higher than the equivalent daycase/elective.

Table 11: Pain related HRG codes and national tariffs, FYs 2010/11 and 2011/12 HRG code

HRG name

National Tariff 2010/11 AB01Z Complex Neurosurgical Pain Procedures AB02Z Complex Major Pain Procedures AB03Z Complex Pain Procedures AB04Z Major Pain Procedures AB05Z AB06Z

Intermediate Pain Procedures Minor Pain Procedures

National Tariff 2011/12 AB01Z Complex Neurosurgical Pain Procedures AB02Z Complex Major Pain Procedures AB03Z Complex Pain Procedures AB04Z Major Pain Procedures AB05Z AB06Z

Intermediate Pain Procedures Minor Pain Procedures

Combined Daycase / Elective tariff (£)

Elective long stay trim point (days)

Nonelective spell tariff (£)

Nonelective long stay trim point (days)

Per day long stay payment (for days exceeding trim point) (£)

Eligible for Specialist Top-up

1,980

5,940

307

Yes

743

4,355

231

Yes

668

3,661

227

Yes

643

2,475

222

Yes

544

2,079

202

Yes

463

1,449

239

Yes

2,503

5,574

209

Yes

708

5,025

209

Yes

636

4,225

209

Yes

612

2,856

209

Yes

518

2,400

209

Yes

229

1,672

209

Yes

Source: NHS Payment by Results 2010-11 National Tariff Information, Department of Health.(133)

4.23

A full list of the individual procedures allocated to each of the pain management HRG codes is given in Appendix I.

NHS CHRONIC PAIN EXPENDITURE IN THE WEST MIDLANDS 4.24

Data from the 2010/11 Programme Budgeting PCT benchmarking tool (134) reported a total expenditure by PCTs in England of £92 billion, of which £1.2 billion were spent on the 7A-Chronic Pain sub-category. The equivalent figures for the PCTs in the West Midlands were a total spend of £9.7 billion of which £119 million (1.2%) were spent on chronic pain.

Chronic Pain Health Needs Assessment

4.25

Table 12 provides the breakdown of the West Midlands spend on chronic pain in 2010/11 by PCT and care setting. Within the West Midlands as a whole the care setting with the largest spend was the inpatient non-elective setting with £55.8 million (47%), followed by inpatient elective and daycase with £29.5 million (25%), primary care prescribing £8.2 million (7%) and outpatients £7.3 million (6%). There was also significant expenditure in community care, ambulance, non-health and social care settings and health and social care provided in other settings. Prevention and health promotion, GP, dental and ophthalmic, and accident and emergency settings recorded no or miniscule expenditure.

4.26

The population of the West Midlands is approximately one-tenth of that of England. In order to compare in expenditure in the West Midlands to that across the country as a whole the figures need to be presented on a per capita basis. Table 13 presents the expenditure per 100,000 unified weighted population, which takes into account the population’s need for hospital and community health services, prescribing and primary medical services. The total expenditure on chronic pain for West Midlands was £2.1 million per 100,000 compared to the national average of £2.4 million. The West Midlands expenditure was lower than national in all care settings other than ambulance, community care, and health and social care. West Midlands expenditure was particularly low in the prevention and health promotion, GP, dental and ophthalmic, outpatient, and other secondary care settings.

4.27

There are marked variations in the expenditure on chronic pain between the West Midlands PCTs, both in terms of the total amounts and the splits between the care settings. Total expenditure varied from £2.6 million in Herefordshire PCT to £14.8 million in South Staffordshire PCT (Figure 1). The variation persists even after expressing the expenditure per 100,000 population weighted for need for hospital and community services. Herefordshire PCT’s spend was the lowest in the region at £1.5 million per 100,000 unified weighted population. Stoke on Trent PCT had the highest spend of £2.7 million per 100,000 - nearly twice that of Herefordshire. The regional average is £2.1 million per 100,000 (Figure 2).

4.28

All of the 17 West Midlands PCTs allocated expenditure for chronic pain to the key care settings, i.e. primary care prescribing, elective and non-elective inpatients, outpatients and ambulance settings. Only 10 PCTs allocated spend to other secondary care, 12 to community care and 6 to health and social care provided in another setting. The percentage splits for each PCT are illustrated in Figure 3.

Chronic Pain Health Needs Assessment

Figure 1: Total expenditure on Programme Budget sub-category 7A-Chronic Pain, West Midlands PCTs, FY 2010/11 South Staffordshire PCT Warwickshire PCT Worcestershire PCT Birmingham East and North PCT Stoke On Trent Teaching PCT

Coventry Teaching PCT Sandwell PCT

PCT

Shropshire County PCT South Birmingham PCT Dudley PCT Wolverhampton City PCT

Heart of Birmingham Teaching PCT Solihull Care Trust North Staffordshire PCT Walsall Teaching PCT Telford and Wrekin PCT Herefordshire PCT 0

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000

Expenditure (£ thousands) Source: Programme Budgeting benchmarking tool 2010/11, Department of Health

Figure 2: Total expenditure per 100,000 unified weighted population on Programme Budget subcategory 7A-Chronic Pain, West Midlands PCTs, FY 2010/11 England West Midlands Stoke On Trent Teaching PCT South Staffordshire PCT Shropshire County PCT Solihull Care Trust Warwickshire PCT Telford and Wrekin PCT PCT

Coventry Teaching PCT Wolverhampton City PCT North Staffordshire PCT Dudley PCT Worcestershire PCT Sandwell PCT Birmingham East and North PCT South Birmingham PCT Heart of Birmingham Teaching PCT Walsall Teaching PCT

Herefordshire PCT 0

500,000

1,000,000

1,500,000

2,000,000

2,500,000

3,000,000

Expenditure (£s) per 100,000 unifed weighted population Source: Programme Budgeting benchmarking tool 2010/11, Department of Health.

Chronic Pain Health Needs Assessment

4.29

Notable variations in the proportional split between the care settings include:  Telford and Wrekin PCT spent a negligible proportion of its chronic pain expenditure on non-elective inpatient care (1% vs. a regional average of 47%) but a very large proportion on inpatient elective care (77% vs. a regional average of 25%).  Solihull PCT spent 16% of its expenditure on health and social care provided in other setting (compared to a regional average of 3%).  Shropshire County PCT allocated 25% of its expenditure to community service compared to a regional average of 4%.  Stoke on Trent Teaching PCT allocated 14% and 26% of its expenditure to community care and health and social care in other settings respectively, compared to regional averages of 4% and 3%.  Sandwell spent virtually nothing in the community and other settings compared to a regional average of 10%.

Figure 3: Proportion of expenditure on Programme Budget sub-category 7A Chronic Pain by care setting, West Midlands PCTs, FY 2010/11 Total West Midlands PCTs South Staffordshire PCT

Warwickshire PCT Worcestershire PCT Birmingham East and North PCT Stoke On Trent Teaching PCT Coventry Teaching PCT Sandwell PCT

PCT

Shropshire County PCT South Birmingham PCT Dudley PCT Wolverhampton City PCT Heart of Birmingham Teaching PCT Solihull Care Trust North Staffordshire PCT Walsall Teaching PCT Telford and Wrekin PCT Herefordshire PCT 0% Prevention & Health Promotion Inpatient: Elective and Daycase Other secondary care Community Care

10%

20%

30%

40%

50%

GP, dental & ophthalmic Inpatient: Non-elective Ambulance Health & social care provided in other setting

60%

70%

80%

90%

100%

Primary prescribing & pharma services Outpatient A&E (inc. MIU & WIC) Non-health / social care

Source: Programme Budgeting benchmarking tool 2010/11, Department of Health.

4.30

Table 13 shows how the total expenditure and the proportional split by care setting for each PCT translate into actual spend in each setting per weighted population. Additional variations highlighted by this table include: 

Low primary care prescribing expenditure in Heart of Birmingham Teaching PCT.

Chronic Pain Health Needs Assessment

 High primary care prescribing expenditure in Stoke on Trent Teaching PCT.  High elective inpatient expenditure in South Staffordshire PCT.  Low elective inpatient expenditure in Birmingham East and North, Heart of Birmingham, South Birmingham, Stoke on Trent and Walsall PCTs.  Low outpatient expenditure in North Staffordshire, South Staffordshire, Walsall and Wolverhampton PCTs.  An expenditure on ambulances three times the regional average in South Staffordshire PCT.

NOTES ON PROGRAMME BUDGET DATA QUALITY AND LIMITATIONS 4.31

There are concerns as to how well the data collected and published by the Programme Budget project accurately reflect the true allocation of expenditure. It is unclear how much of the variation described above reflects real differences in activity or service models and how much is an artefact of differential coding or erroneous reporting. The Audit Commission has identified and described issues with NHS data definitions and how they are implemented by local providers and commissioners. (135). These issues affect the collection of data for Payment by Results (PbR) but are also a concern for secondary uses of data such as for the Programme Budget project. Two key problems are:  Defining short stay activity as a daycase admission or an outpatient attendance  Defining a short period of observation as a non-elective admission or a ward attendance (which is treated as an outpatient attendance).

4.32

The existing commissioning data sets do not allow the recording of information in the same manner in different settings and do not necessarily reflect the current delivery of care. When activity takes place in inpatients the data recorded is exhaustive. If this activity moves to outpatients much of this detail disappears, including that on diagnosis. If this activity then moves to a community or primary care setting it can vanish completely, and without detailed local knowledge it would appear this activity no longer takes place. The difference in tariff between elective, non-elective and outpatient settings for what may be the same activity can also act as a disincentive to record activity accurately and to properly align costs with activity.

4.33

The majority of activity carried out by Pain Management specialists is delivered in outpatients. However, the focus for clinical coding in the NHS has been concentrated on admitted patients, because there are both time and resource implications in coding significant amounts of outpatient activity. Pain Management services need to understand if and how their data is coded and ensure that their activity is correctly recorded on their patient administration system (PAS).(136) The NHS Information Centre (NHSIC) report that their Expert Working Group for Pain Management have reviewed national patient activity and found that some Pain Management services are unaware that their activity could and should be captured in a more appropriate way. This could be due to a lack of awareness of

Chronic Pain Health Needs Assessment

the coding systems and the reasons why coding is important. This inaccuracy can lead to underreporting of the actual total costs submitted for calculating the PbR tariffs as well underreporting and misclassification of expenditure for the Programme Budget project.

Chronic Pain Health Needs Assessment

Table 12: Expenditure (ÂŁ thousands) on Programme Budget sub-category 7A-Chronic Pain by care setting, West Midlands PCTs, FY 2010/11 PCT

PCT Name

Care setting Prevention & health Promotion

5PG

Primary care

Secondary care

GP, dental & ophthalmic

Primary prescribing & pharma services

Inpatient: elective and daycase

Inpatient: nonelective

Urgent / emergency care

Outpatient

547

1,287

5,403

808

5MD

Birmingham East and North PCT Coventry Teaching PCT

513

2,184

4,057

5PE

Dudley PCT

473

1,409

3,568

5MX

287

674

5CN

Heart of Birmingham Teaching PCT Herefordshire PCT

189

5PH

North Staffordshire PCT

5PF

Sandwell PCT

5M2

Shropshire County PCT

TAM

Solihull Care Trust

5M1

Other secondary care

Ambulance

A&E (inc. MIU & WIC)

255

349

207

460

160

3,261

471

243

523

1,343

178

115

370

1,399

2,134

104

124

587

1,721

3,510

645

449

198

407

1,029

2,722

246

378

182

249

732

2,182

411

117

South Birmingham PCT

477

1,071

4,040

762

219

5PK

South Staffordshire PCT

961

5,884

6,027

244

952

5PJ

615

652

2,892

568

174

5MK

Stoke On Trent Teaching PCT Telford and Wrekin PCT

247

2,793

278

101

5M3

Walsall Teaching PCT

477

832

2,476

176

164

5PM

Warwickshire PCT

734

3,271

4,729

520

524

302

5MV

Wolverhampton City PCT

387

806

3,363

195

232

166

5PL

Worcestershire PCT

675

3,227

4,076

850

334

Q34

West Midlands

Eng

England

8,195

29,494

55,803

7,265

1,802

4,013

187

475

78,647

296,341

610,377

103,453

53,350

29,585

Source: 2010-11 Programme budgeting PCT benchmarking tool, Department of Health. (134)

Chronic pain health needs assessment 49

Table 13: Expenditure (ÂŁ) per 100,000 unified weighted population on Programme Budget subcategory 7A-Chronic Pain by care setting, West Midlands PCTs, FY 2010/11 PCT

PCT Name

Care setting Prevention & health Promotion

5PG

Primary care

Secondary care

GP, dental & ophthalmic

Primary prescribing & pharma services

Inpatient: elective and daycase

Inpatient: nonelective

Outpatient

Urgent / emergency care Other secondary care

Ambulance

120,929

284,526

1,194,479

178,630

56,375

5MD

Birmingham East and North PCT Coventry Teaching PCT

147,589

628,331

1,167,188

100,406

59,553

5PE

Dudley PCT

150,516

448,367

1,135,395

146,379

7,319

50,915

5MX

92,500

217,229

1,051,016

151,803

25,139

78,319

5CN

Heart of Birmingham Teaching PCT Herefordshire PCT

109,334

302,549

776,909

102,971

5,206

66,526

5PH

North Staffordshire PCT

172,968

654,005

997,603

48,618

57,968

5PF

Sandwell PCT

162,210

475,577

969,944

178,238

124,076

54,715

5M2

Shropshire County PCT

144,331

364,906

965,282

87,237

134,047

64,541

TAM

Solihull Care Trust

129,921

381,935

1,138,501

214,447

61,047

5M1

South Birmingham PCT

124,393

279,297

1,053,557

198,715

57,111

5PK

South Staffordshire PCT

166,525

1,019,597

1,044,376

42,281

164,965

5PJ

195,923

207,710

921,317

180,950

55,432

5MK

Stoke On Trent Teaching PCT Telford and Wrekin PCT

1,213

4,852

149,811

1,694,015

12,130

168,613

2,426

61,259

5M3

Walsall Teaching PCT

167,741

292,579

870,705

61,892

7,033

57,672

5PM

Warwickshire PCT

148,637

662,385

957,633

105,301

106,111

61,156

5MV

Wolverhampton City PCT

141,127

293,923

1,226,382

71,110

84,603

60,535

5PL

Worcestershire PCT

129,968

621,344

784,815

163,664

16,366

64,310

Q34

West Midlands

141

144,843

521,295

986,296

128,406

31,850

70,928

Eng

England

357

907

150,177

565,865

1,165,519

197,544

101,872

56,493

Source: 2010-11 Programme budgeting PCT benchmarking tool, Department of Health. (134)

A&E (inc. MIU & WIC)

Chronic Pain Health Needs Assessment

5 HEALTH SERVICE UTILISATION - OUTPATIENT ACTIVITY COMMISSIONER PERSPECTIVE 5.1 This section describes the growth in out-patient activity in pain services provided by secondary care facilities. Outpatient commissioning data sets (CDS) for the financial years 2007/8 to 2011/12, accessed via Healthcare Commissioning Services, Dudley. The Outpatient CDS carries the data for an outpatient attendance or a cancelled/missed appointment. It covers all NHS and private outpatient activity taking place under the care of a consultant, midwife or nurse in any: Acute, community or mental health NHS Trust Primary Care Trust Other NHS hospital Non-NHS hospitals or institutions where the care delivered is NHS-funded. 5.2 Providers of NHS commissioned care must submit and make available the CDSs to commissioners. Within the West Midlands the data sets are submitted to, stored and accessed via a data warehouse managed by Healthcare Commissioning Services (HCS), based in Dudley. Two outpatient data requests were submitted to HCS for counts of attendances of adults aged 16 years and over to pain management clinics where the patient attended and was seen for the financial years 2007/8 to 2011/12. 5.3 For patients resident in West Midlands PCTS: counts were broken down by financial year, gender, first attendance status and PCT. For patients attending the West Midlands providers: counts broken down by financial year, gender, first attendance status and Provider Trust. The resulting outputs included counts where the first attendance status was for first or follow-up tele-consultations. These counts were excluded from the further analysis â&#x20AC;&#x201C; only first and follow-up face to face consultations were included. 5.4 There were a total of 245,331 attendances at outpatient pain management clinics for adults resident in the West Midlands and treated by any provider during the 5-year period 2007/8 to 2011/12 (Table 14 ). Of these 76,830 (31%) were first attendances and 168,501 (69%) were follow-up attendances. The total number of attendances increased from 44,700 in 2007/8 to 51,587 in 2011/12, a rise of 15%. The rate of increase over the period was greater for first attendances (35%) compared to follow-up attendances (8%) (figure 2). Consequently the proportion of first attendances also increased over the 5 years, from 29% in 2007/8 to 33% in 2011/12.

Chronic Pain Health Needs Assessment

Table 14. Pain management outpatient clinic attendances for residents in West Midlands aged 16+ years by gender by attendance type, FYs 2007/08 to 2011/12. Gender

Attendance type

Financial year 2007/08

2008/09

2009/10

Total all years 2010/11

2011/12

Male

First attendance face to face

4,563

5,090

5,548

5,956

5,977

27,134

Male

Follow-up attendance face to face

10,467

10,608

11,115

11,332

11,085

54,607

Male

Total

15,030

15,698

16,663

17,288

17,062

81,741

Female

First attendance face to face

8,228

8,986

10,266

10,949

11,267

49,696

Female

Follow-up attendance face to face

21,442

21,628

23,633

23,933

23,258

113,894

Female

Total

29,670

30,614

33,899

34,882

34,525

163,590

Persons

First attendance face to face

12,791

14,076

15,814

16,905

17,244

76,830

Persons

Follow-up attendance face to face

31,909

32,236

34,748

35,265

34,343

168,501

Persons

Total

44,700

46,312

50,562

52,170

51,587

245,331

Persons

Percentage of first attendances

28.6%

30.4%

31.3%

32.4%

33.4%

31.3%

Persons

95% confidence interval lower limit [1]

28.2%

30.0%

30.9%

32.0%

33.0%

31.1%

Persons

95% confidence interval upper limit [1]

29.0%

30.8%

31.7%

32.8%

33.8%

31.5%

Source: Outpatient Commissioning Data Set, Healthcare Commissioning Services Notes: [1] based on the Wilson score method.

Count of attendances (thousands)

40.0% 35.0%

30.0%

25.0%

20.0% 15.0%

10.0%

5.0%

0.0%

2007/08

2008/09

2009/10 2010/11 Financial year

2011/12

Source: Outpatient Commissioning Data Set, Figure 4. Pain management outpatient clinic attendances for residents in West Midlands aged 16+ by attendance type, FYs 2007/8 to 2011/12. The blue line shows first attendances, the red line shows follow-up attendances and the green line shows the total attendances. The black dotted line shows the % of the total that are first attendances (right hand axis)

Chronic Pain Health Needs Assessment

Table 15: Pain management outpatient clinic attendances for West Midlands residents aged 16+ by Primary Care Trust and attendance type, FYs 2007/8 to 20011/12. Primary Care Trust / Cluster

Population years at risk [1]

First attendance face to face

Follow-up attendance face to face

Total

Percentage of first attendances

Crude first attendance rate [2]

Percent

Rate

95% CI limits [3] Lower

5PG 5MD 5PE 5MX 5CN 5PH 5PF 5M2 5QW 5M1 5PK 5PJ 5MK 5M3 5PM 5MV 5PL

Upper

95% CI limits [4] Lower

Crude total attendance rate [2] Rate

Upper

95% CI limits [4] Lower

Upper

Birmingham East and North PCT Coventry Teaching PCT Dudley PCT Heart of Birmingham Teaching PCT Herefordshire PCT North Staffordshire PCT Sandwell PCT Shropshire County PCT Solihull PCT South Birmingham PCT South Staffordshire PCT Stoke On Trent PCT Telford and Wrekin PCT Walsall Teaching PCT Warwickshire PCT Wolverhampton City PCT Worcestershire PCT

1,565,426 1,256,540 1,244,319 1,051,302 739,725 878,079 1,146,991 1,197,926 827,616 1,381,884 2,486,734 1,000,465 643,451 1,011,340 2,180,531 959,676 2,273,231

7,732 5,084 4,729 5,299 1,695 1,218 7,784 3,596 4,746 6,551 2,716 2,351 2,543 921 6,483 2,767 10,615

19,545 7,795 11,654 13,821 3,225 1,965 19,675 6,897 11,275 23,290 4,993 3,212 4,781 1,965 11,767 4,204 18,437

27,277 12,879 16,383 19,120 4,920 3,183 27,459 10,493 16,021 29,841 7,709 5,563 7,324 2,886 18,250 6,971 29,052

28.3% 39.5% 28.9% 27.7% 34.5% 38.3% 28.3% 34.3% 29.6% 22.0% 35.2% 42.3% 34.7% 31.9% 35.5% 39.7% 36.5%

27.8% 38.6% 28.2% 27.1% 33.1% 36.6% 27.8% 33.4% 28.9% 21.5% 34.2% 41.0% 33.6% 30.2% 34.8% 38.6% 36.0%

28.9% 40.3% 29.6% 28.4% 35.8% 40.0% 28.9% 35.2% 30.3% 22.4% 36.3% 43.6% 35.8% 33.6% 36.2% 40.8% 37.1%

4.9 4.0 3.8 5.0 2.3 1.4 6.8 3.0 5.7 4.7 1.1 2.3 4.0 0.9 3.0 2.9 4.7

4.8 3.9 3.7 4.9 2.2 1.3 6.6 2.9 5.6 4.6 1.1 2.3 3.8 0.9 2.9 2.8 4.6

5.1 4.2 3.9 5.2 2.4 1.5 6.9 3.1 5.9 4.9 1.1 2.4 4.1 1.0 3.0 3.0 4.8

17.4 10.2 13.2 18.2 6.7 3.6 23.9 8.8 19.4 21.6 3.1 5.6 11.4 2.9 8.4 7.3 12.8

17.2 10.1 13.0 17.9 6.5 3.5 23.7 8.6 19.1 21.4 3.0 5.4 11.1 2.8 8.2 7.1 12.6

17.6 10.4 13.4 18.4 6.8 3.8 24.2 8.9 19.7 21.8 3.2 5.7 11.6 3.0 8.5 7.4 12.9

Arden Birmingham and Solihull Black Country Staffordshire West Mercia

3,437,071 4,826,227 4,362,326 4,365,277 4,854,333

11,567 24,328 16,201 6,285 18,449

19,562 67,931 37,498 10,170 33,340

31,129 92,259 53,699 16,455 51,789

37.2% 26.4% 30.2% 38.2% 35.6%

36.6% 26.1% 29.8% 37.5% 35.2%

37.7% 26.7% 30.6% 38.9% 36.0%

3.4 5.0 3.7 1.4 3.8

3.3 5.0 3.7 1.4 3.7

3.4 5.1 3.8 1.5 3.9

9.1 19.1 12.3 3.8 10.7

9.0 19.0 12.2 3.7 10.6

9.2 19.2 12.4 3.8 10.8

21,845,235

76,830

168,501

245,331

31.3%

31.1%

31.5%

3.5

11.2

11.3

Total All West Midlands PCOs

Source: Outpatient Commissioning Data Set, Healthcare Commissioning Services; Mid-year population estimates, Office for National Statistics. [1] Based on ONS mid-year population estimates for the years 2007 to 2010, current as of September 2011. Estimates for 2010 are also used as proxies for 2011 as data for this year are yet to be published. [2] Rates are expressed per 1,000 population years at risk. [3] Based on the Wilson score method(137). [4] Based on Byar's approximation to the Poisson distribution(138)

Chronic pain health needs assessment

5.5 Table 15 shows the detailed data on first and follow-up outpatient attendances and the crude attendance rate (per 1000 person- years) for each of the Primary Care Trusts in the West Midlands. Since we used 5 years of data to calculate the crude attendance rate, we used person-years at risk as the denominator. In effect this can be regarded as the rate per 1000 residents who are have sufficiently severe and disabling chronic pain to be seen in a secondary care pain clinic. There is considerable variation between PCTs. For first attendances it varies more than 7-fold from 0.9 per 1000 in Walsall to 6.8 per 1000 in Sandwell. We did not investigate the reasons for this variation but almost certainly it results from a combination of availability of services, ability of general practices to manage chronic pain, referral threshold and traditional referral practices. It appears unlikely that true variation in the incidence or prevalence of chronic pain accounts for more than a small part of this variation. 5.6 The trend in outpatient attendances by PCT Cluster, and crude attendance rate are shown in Table 16. Once again there is considerable variation between clusters, and this is shown in Figure 5; Birmingham and Black Country cluster have the highest rate, about 4 times the rate of Staffordshire. Table 16. Crude rate of all attendances to pain management outpatient clinics for West Midlands residents aged 16+ years by PCT Cluster, FYs 2007/08 to 2011/12. PCT Cluster 2007/08

Financial year 2008/09 2009/10 2010/11

2011/12

Total all years

Total attendances Arden 5,407 5,999 6,766 6,519 6,438 31,129 Birmingham and Solihull 17,638 17,565 19,341 19,537 18,178 92,259 Black Country 11,109 10,046 11,352 10,740 10,452 53,699 Staffordshire 2,451 2,936 3,479 3,877 3,712 16,455 West Mercia 8,095 9,766 9,624 11,497 12,807 51,789 Total West Midlands 44,700 46,312 50,562 52,170 51,587 245,331 residents Crude attendance rate Arden 8.0 8.8 9.8 9.4 9.3 9.1 Birmingham and Solihull 18.5 18.3 20.0 20.1 18.7 19.1 Black Country 12.8 11.5 13.0 12.3 11.9 12.3 Staffordshire 2.8 3.4 4.0 4.4 4.2 3.8 West Mercia 8.4 10.1 9.9 11.8 13.1 10.7 Total West Midlands 10.3 10.6 11.6 11.9 11.7 11.2 residents Source: Outpatient Commissioning Data Set, Healthcare Commissioning Services; Mid-year population estimates, Office for National Statistics.

Chronic pain health needs assessment 55

Crude rate per 1,000 population years at risk

5 Arden Staffordshire

0 2007/08

2008/09

Birmingham and Solihull West Mercia

2009/10

2010/11

Black Country West Midlands average

2011/12

Financial year Source: Outpatient Commissioning Data Set, Healthcare Commissioning Services. Figure 5. Crude rates of attendance at pain management clinics by residents in West Midlands aged 16+ by PCT Cluster, FYs 2007-8 to 2011-12.

5.7 The variation in rates of outpatient attendance between PCTs and Clusters is shown in the funnel plots (Figure 6, Figure 7 and Figure 8). These charts show the dispersion of PCT and cluster rates around the average rate for the West Midlands with the +/- 2 SD and +/- 3 SD control limits denoting the expected common cause variation due to statistical chance alone.

Chronic Pain Health Needs Assessment

West Midlands average 2SD limits

Crude rate per 1,000 population years at risk

3SD Limits PCTs PCT Clusters

0 0

1,000,000

2,000,000 3,000,000 4,000,000 Population years at risk

5,000,000

Source: Outpatient Commissioning Data Set, Healthcare Commissioning Services; Mid-year population

Figure 6. Funnel plot of crude rate of all attendances to pain management outpatient clinics , West Midlands residents aged 16+ by PCT and Cluster, FYs 2007/8 to 2011/12.

West Midlands average 2SD limits 3SD Limits PCTs PCT Clusters

Crude rate per 1,000 population years at risk

7 6 5 4 3 2 1 0 0

1,000,000

2,000,000 3,000,000 Population years at risk

4,000,000

5,000,000

Source: Outpatient Commissioning Data Set, Healthcare Commissioning Services; Mid-year population

Figure 7. Funnel plot of crude rte of first attendances to pain management outpatient clinics West Midlands residents aged 16+ by PCT and Cluster, FYs 2007/8 to 2011/12.

Chronic Pain Health Needs Assessment

Percentage of first attendances

35 30 25 20 15

West Midlands average 2SD limits 3SD Limits PCTs PCT Clusters

10 5 0 0

20,000

40,000 60,000 Number of attendances

80,000

100,000

Source: Outpatient Commissioning Data Set, Healthcare Commissioning Services.

Figure 8. Funnel plot of First attendances as a percentage of all attendances to Pain management outpatient clinics, West Midlands residents aged 16+ by PCT and PCT cluster, FYs 2007/8 to 2011/12. OUT-PATIENT ACTIVITY â&#x20AC;&#x201C; PROVIDER PERSPECTIVE

5.8 Table 17 shows the attendances to outpatient pain management clinics for each of the West Midlands Provider Trusts. It includes all patients treated at the Trusts, including those residents outside of the West Midlands region. There were a total of 229,736 attendances to the West Midlands providers. This is over 15,000 fewer attendances than reported for the West Midlands residents. This suggests a net flow of patients being treated by providers outside the region. Three Trusts undertook significantly larger volumes of activity: The Royal Orthopaedic Hospital NHS Trust in south Birmingham (47,514), Sandwell and West Birmingham Hospitals NHS Trust (39,889) and the Heart of England NHS Foundation Trust in east Birmingham and Solihull (32,245). 5.9 The average percentage of first attendances across the regional providers was 31.1%, which matches that seen for the West Midlands resident patients. Percentages varied from a low of 17.3% at the Royal Orthopaedic Hospital NHS Trust to 45.1% at the Worcestershire Acute Hospitals NHS Trust. The distribution of the percentage of first attendances by provider trust displays over-dispersion when compared to the control limits around the regional average (Figure 9).

Chronic Pain Health Needs Assessment

Table 17. Pain management outpatient clinic attendances for West Midlands provider patients aged 16+ years by Provider Trust by attendance type, FYs 2007/08 to 2011/12 Provider Trust

RJC

First Follow-up attendance attendance face to face face to face

Total

Percentage of first attendances Percent

95% CI limits [1] Lower Upper

2,410

3,339

5,749

41.9% 40.7% 43.2%

3,687

5,203

8,890

41.5% 40.5% 42.5%

6,158

8,075

14,233

43.3% 42.5% 44.1%

1,048

4,258

5,306

19.8% 18.7% 20.8%

3,301

4,669

7,970

41.4% 40.3% 42.5%

RLT

SOUTH WARWICKSHIRE NHS FOUNDATION TRUST UNIVERSITY HOSPITAL OF NORTH STAFFORDSHIRE NHS TRUST UNIVERSITY HOSPITALS COVENTRY AND WARWICKSHIRE NHS TRUST THE ROBERT JONES AND AGNES HUNT ORTHOPAEDIC HOSPITAL NHS FOUNDATION TRUST THE ROYAL WOLVERHAMPTON HOSPITALS NHS TRUST GEORGE ELIOT HOSPITAL NHS TRUST

1,996

6,000

7,996

25.0% 24.0% 25.9%

RNA

THE DUDLEY GROUP NHS FOUNDATION TRUST

5,700

13,289

18,989

30.0% 29.4% 30.7%

RR1

HEART OF ENGLAND NHS FOUNDATION TRUST

10,998

21,247

32,245

34.1% 33.6% 34.6%

RRJ

THE ROYAL ORTHOPAEDIC HOSPITAL NHS FOUNDATION TRUST UNIVERSITY HOSPITALS BIRMINGHAM NHS FOUNDATION TRUST WORCESTERSHIRE ACUTE HOSPITALS NHS TRUST

8,230

39,284

47,514

17.3% 17.0% 17.7%

5,281

7,829

13,110

40.3% 39.4% 41.1%

6,836

8,334

15,170

45.1% 44.3% 45.9%

SANDWELL AND WEST BIRMINGHAM HOSPITALS NHS TRUST SHREWSBURY AND TELFORD HOSPITAL NHS TRUST Total All West Midlands Providers

10,740

29,149

39,889

26.9% 26.5% 27.4%

5,033

7,642

12,675

39.7% 38.9% 40.6%

71,418

158,318

229,736

31.1% 30.9% 31.3%

RJE RKB RL1

RL4

RRK RWP RXK RXW

Source: Outpatient Commissioning Data Set, Healthcare Commissioning Services. Notes: [1] Based on the Wilson score method(137).

Chronic Pain Health Needs Assessment

Percentage of first attendances

45 40 35 30 25 20

West Midlands average 2SD limits 3SD Limits PCTs PCT Clusters

15 10 5 0 0

10,000

20,000 30,000 Number of attendances

40,000

50,000

Source: Outpatient Commissioning Data Set, Healthcare Commissioning Services.

Figure 9. Funnel plot of first attendances as a percentage of all attendances to pain management outpatient clinics West Midlands provider patients aged 16+ by provider Trust, FYs 2007/8 to 2011/12. 5.10 5.11 A note on over- dispersion. We have used funnel plots to show the extent of variation between PCTs and between provider units in this and the following sections. Funnel plots present control limits that display ‘common-cause’ or process variation. This is the variation that can be expected to occur in a process that is stable or ‘under control’. The limits are calculated under the assumption that the only source of common-cause variation in the process is that of random variation. Variation outside these limits is often called special-cause or extra-process variation and is the result of systematic or unusual deviations in the process. In the funnel plots above, the distributions show much greater variation than that of the expected ‘common-cause’. This is known as over-dispersion and often occurs when there are large numbers of events, and confounding factors that influence the process are not accounted for. Whether these factors are considered legitimate and should be included as source of common-cause variation or remain as special causes is a matter of judgement and will depend on the purpose of the monitoring. For example, in performance management the purpose is to identify differences in organisational performance and consequently it is usual to adjust the control limits or the data to eliminate potential sources of variation, such as casemix and demography. In public health the purpose is often to highlight the sources of such variation for their own sake so the control limits are left unaltered. The APHO monograph(139) on statistical process control charts gives more detail on the methodology and interpretation.

Chronic Pain Health Needs Assessment

6 HEALTH SERVICE UTILISATION â&#x20AC;&#x201C; INPATIENT AND DAY CASE PROCEDURES 6.1 This chapter describes the growth in hospital-based clinical activity for chronic pain. Surgical and other interventional procedures are carried out either as day cases or as inpatient episodes of care. The analysis presented here relates to clinical work undertaken on West Midlands residents (regardless of where it was done); and, separately, work done by West Midlands provider Trusts (regardless of the geographic residence of patients.

DATA SOURCES AND METHODS 6.2 The source of data was the Admitted Patient commissioning data sets (CDS) for the financial years 2007/8 to 2011/12, accessed via Healthcare Commissioning Services, Dudley. This data set records clinical details for every finished consultant episode. ). It covers all NHS and private inpatient activity taking place under the care of a consultant, midwife or nurse in any: Acute, community or mental health NHS Trust Primary Care Trust Other NHS hospital Non-NHS hospitals or institutions where the care delivered is NHS-funded. 6.3 Providers of NHS commissioned care must submit and make available the CDSs to commissioners. Within the West Midlands the data sets are submitted to, stored and accessed via a data warehouse managed by Healthcare Commissioning Services (HCS), based in Dudley. Four inpatient data requests were submitted to HCS for counts of FCEs of adults aged 16 years and over where the primary procedure recorded for the episode was a pain management procedure and the episode was completed during the financial years 2007/8 to 2011/12. Patients treated by the West Midlands providers: counts broken down by financial year, gender, admission method, patient classification and Provider Trust. Patients treated by the West Midlands providers: counts broken down by financial year, gender, primary procedure and Provider Trust. Patients resident in West Midlands PCTS: counts broken down by financial year, gender, admission method, patient classification and PCT. Patients resident in West Midlands PCTS: counts broken down by financial year, gender, primary procedure and PCT. 6.4 Full details of the specifications are given in Appendix I. The list of pain management procedures is given in Appendix II, specified by OPCS4 procedure codes at the 4-digit level. 6.5 Obvious data errors were found by inspection of the output counts. These related to the fields on patient classification and method of admission, where the codes clearly showed that the relevant FCE were maternity or delivery episodes. For the provider patients based output (output 1) this represented a total count of 206 out of 154,097 FCEs. For the resident based output (output 3) this represented a total count of 212 out

Chronic Pain Health Needs Assessment

of 161,782 FCEs. These categories were excluded from all further analyses of these outputs. Ideally the episodes with these methods of admission and/or patient classification would also be excluded from the corresponding outputs of counts broken down by procedure (outputs 2 and 4). This was not possible as these outputs do not contain the method of admission and patient classification breakdown needed to identify them. However, given the very small number of episodes involved the inclusion of these episodes in the procedure based analyses is negligible.

RESULTS 6.6 Pain management inpatient procedure episodes. There were a total of 161,570 inpatient episodes for pain management procedures for adults resident in the West Midlands and treated by any provider during the 5-year period 2007/8 to 2011/12 (Table 18). Of these, 86% were elective day cases, 8% were elective ordinary admissions, 2% elective regular attenders and 4% were emergency admissions (Figure 10). Women accounted for 62% of episodes compared to 38% for men. Elective episodes. The main interest of this report is elective activity. Over the five years a total of 154,478 (96%) of the episodes were for elective procedures. The episode count increased from 26, 523 in the year 2007/8 to 33, 583 in 2009/10 but since then has fallen again to 30,863 in 2011/12 (Table 18, Figure 11). Over the 5-year period, day cases accounted for 89.7% of the elective activity. This proportion slowly increased from 87.4% in 2007/8 to 92.0% in 2011/12. The trend in the number of day cases follows that described for all elective activity (Figure 11) 6.7 Table 18 also presents the volume of elective pain management procedure episodes as a rate against the denominator resident population. Overall there were 7.1 elective episodes for every 1,000 population years at risk. Over the five years the adult population of the West Midlands increased only marginally (by less than 2%). Consequently the annual trend in the rate over the five years mirrors that of the simple counts described in figure 3. The rate increased from 6.1 in 2007/8 to 7.7 in 20089/10 and has since fallen to 7.0 in 2011/12 (Figure 12).

Chronic Pain Health Needs Assessment

Table 18. Pain management inpatient procedure episodes for West Midlands residents aged 16+ years by gender, method of admission and patient classification, FYs 2007/08 to 2011/12 Gender

Method of Admission

Patient Classification

Male

Emergency

Total

Male Male Male Male

Elective Elective Elective Elective

Total Day case Ordinary admission Regular attender

Other and unspecified Male

Total

Female

Emergency

Total

Female Female Female Female

Elective Elective Elective Elective

Total Day case Ordinary admission Regular attender

Other and unspecified Female

Total

Persons

Emergency

Total

Persons Persons Persons Persons

Elective Elective Elective Elective

Total Day case Ordinary admission Regular attender

Other and unspecified

Financial year

Total all years

2007/08

2008/09

2009/10

2010/11

2011/12

499

588

767

777

790

3,421

9,666 8,291 1,144 231

11,373 9,722 1,197 454

12,454 11,112 982 360

11,933 10,722 988 223

11,470 10,382 1,029 59

56,896 50,229 5,340 1,327

376

10,235

12,018

13,302

12,792

12,346

60,693

531

580

594

606

642

2,953

16,856 14,877 1,544 435

19,991 17,551 1,593 847

21,102 19,172 1,293 637

20,204 18,671 1,156 377

19,390 18,007 1,286 97

97,543 88,278 6,872 2,393

342

17,458

20,640

21,768

20,877

20,095

100,838

1,030

1,168

1,361

1,383

1,432

6,374

26,523 23,169 2,688 666

31,366 27,275 2,790 1,301

33,583 30,311 2,275 997

32,143 29,399 2,144 600

30,863 28,392 2,315 156

154,478 138,546 12,212 3,720

141

126

153

149

718

27,694

32,660

35,097

33,675

32,444

161,570

4,325,91 1

4,353,75 0

4,374,39 3

4,395,59 1

21,845,23 5

7.7 7.6 7.8

7.3 7.2 7.4

7.0 6.9 7.1

7.1 7.0 7.1

90.3% 89.9% 90.6%

91.5% 91.2% 91.8%

92.0% 91.7% 92.3%

89.7% 89.5% 89.8%

Persons

Total

Persons

Populati on

Persons Persons Persons

Crude elective episode rate [1] 95% confidence interval lower limit [2] 95% confidence interval upper limit [2]

6.1 6.1 6.2

7.2 7.1 7.3

Persons Persons Persons

Day case as a % of all elective episodes 95% confidence interval lower limit [3] confidence interval upper 95% limit [3]

87.4% 86.9% 87.7%

87.0% 86.6% 87.3%

Source: Admitted Patient Commissioning Data Set, Healthcare Commissioning Services. Notes : [1] Rates are expressed per 1,000 population years at risk. (138) [2] Based on Byar's approximation to the Poisson distribution. [3] Based on the Wilson score method(137)

Chronic Pain Health Needs Assessment

Ordinary admission 12,212 8%

Day case 138,546 86%

Regular attender 3,720 2% Emergency 6,374 4% Other and unspecified 718 0%

Source: Admitted Patient Commissioning Data Set, Healthcare Figure 10. Pain management in-patient procedure episodes f0or West Midlands residents aged 16+ by method of admission and pat8ient classification, FYâ&#x20AC;&#x2122;s 2007/8 to 2011/12.

40 Count of episodes (thousands)

Elective - Total

Elective - day case

Elective - ordinary admission

35 30 25 20 15 10

5 0 2007/08

2008/09

2009/10 Financial year

2010/11

2011/12

Source: Admitted Patient Commissioning Data Set, Healthcare Commissioning Services.

Figure 11. Elective pain management in-patient procedure episodes for West Midlands residents aged 16+ by method of admission and patient classification, FYs 2007/8 to 2011/12.

Chronic pain health needs assessment 64

Crude rate per 1,000 population

9 8 7 6 5 4 3 2 1 0 2007/08

2008/09

2009/10 Financial year

2010/11

2011/12

I = 95% confidence interval

Source: Admitted Patient Commissioning Data Set, Healthcare Commissioning Services.

Figure 12. Crude episode rates for elective pain management in-patient procedures for West Midlands residents aged 16+ by FYs 2007/8 to 2011/12.

6.8 Table 19. Provides a breakdown of the episode count and crude population episode rate for the 5-year period by Primary Care Trust (PCT) and PCT Cluster. At PCT level, there is a large variation in the total number of elective episodes ranging from 2,712 in Telford & Wrekin PCT to 18,673 in Dudley PCT. This variation in the counts is not simply due to the different population sizes of the PCTs. When expressed as a crude rate per 1,000 population years at risk the crude elective admission rates for PCTs exhibit almost four-fold variation (from 4.1 in Heart of Birmingham PCT to 15.0 in Dudley PCT). 6.9

Figure 13. Displays these rates against a funnel plot of the control limits based on West Midlands average rate of 7.1 and the expected â&#x20AC;&#x2DC;common-causeâ&#x20AC;&#x2122; variation due to chance alone. The observed distribution shows clear over-dispersion beyond the control limits. Similar over-dispersion is seen at PCT Cluster level with rates ranging from 6.0 in Birmingham and Solihull cluster to 9.4 in the Black Country.

6.10 The proportion of elective episodes that are treated as day cases may highlight differences in practice for the care commissioned by the PCTs. For the West Midlands region as a whole, day cases comprised 89.7% of elective episodes. At PCT level this ranged from a low of 81.4% in Shropshire PCT to 95.0% in Warwickshire PCT. Cluster level values ranged from 86.5% in West Mercia to 94.4% in Arden. The PCT and Cluster distributions display over-dispersion when compared to the control limits around the West Midlands regional average (Figure 14)

Chronic Pain Health Needs Assessment

Table 19. Pain management inpatient procedure episodes for West Midlands residents aged 16+ years by Primary Care Trust by admission method and patient classification, FYs 2007/08 to 2011/12 Primary Care Trust \ Cluster

5PG 5MD 5PE 5MX 5CN 5PH 5PF 5M2 5QW 5M1 5PK 5PJ 5MK 5M3 5PM 5MV 5PL

Population years at risk [1]

Emergency episodes

1,565,426 1,256,540 1,244,319 1,051,302 739,725 878,079 1,146,991 1,197,926 827,616 1,381,884 2,486,734 1,000,465 643,451 1,011,340 2,180,531 959,676 2,273,231

310 424 547 340 341 190 343 369 147 401 709 262 146 470 456 270 649

Arden Birmingham and Solihull Black Country Staffordshire West Mercia

3,437,071 4,826,227 4,362,326 4,365,277 4,854,333 21,845,235

Total All West Midlands PCOs

Elective episodes Day cases

Total

Other and unspecifâ&#x20AC;&#x2122;d episodes

Total episodes

Day case as % of elective Percent

95% CI [3] LL UL

Crude elective rate [2] Rate 95% CI [4] LL UL

Ordinary

Regular

7,339 11,012 16,854 3,834 2,998 3,874 9,107 4,297 3,404 10,722 15,987 4,893 2,314 6,009 14,533 5,199 16,170

436 728 1,767 216 384 493 589 970 166 648 1,694 634 392 681 730 478 1,206

504 20 52 234 7 6 242 12 136 1,137 209 4 6 64 30 4 1,053

8,279 11,760 18,673 4,284 3,389 4,373 9,938 5,279 3,706 12,507 17,890 5,531 2,712 6,754 15,293 5,681 18,429

31 38 28 16 45 14 37 86 8 50 102 25 20 68 49 47 54

8,620 12,222 19,248 4,640 3,775 4,577 10,318 5,734 3,861 12,958 18,701 5,818 2,878 7,292 15,798 5,998 19,132

88.6% 93.6% 90.3% 89.5% 88.5% 88.6% 91.6% 81.4% 91.9% 85.7% 89.4% 88.5% 85.3% 89.0% 95.0% 91.5% 87.7%

87.9% 93.2% 89.8% 88.5% 87.3% 87.6% 91.1% 80.3% 90.9% 85.1% 88.9% 87.6% 83.9% 88.2% 94.7% 90.8% 87.3%

89.3% 94.1% 90.7% 90.4% 89.5% 89.5% 92.2% 82.4% 92.7% 86.3% 89.8% 89.3% 86.6% 89.7% 95.4% 92.2% 88.2%

5.3 9.4 15.0 4.1 4.6 5.0 8.7 4.4 4.5 9.1 7.2 5.5 4.2 6.7 7.0 5.9 8.1

5.2 9.2 14.8 4.0 4.4 4.8 8.5 4.3 4.3 8.9 7.1 5.4 4.1 6.5 6.9 5.8 8.0

5.4 9.5 15.2 4.2 4.7 5.1 8.8 4.5 4.6 9.2 7.3 5.7 4.4 6.8 7.1 6.1 8.2

880 1,198 1,630 1,161 1,505

25,545 25,299 37,169 24,754 25,779

1,458 1,466 3,515 2,821 2,952

50 2,011 362 219 1,078

27,053 28,776 41,046 27,794 29,809

87 105 180 141 205

28,020 30,079 42,856 29,096 31,519

94.4% 87.9% 90.6% 89.1% 86.5%

94.1% 87.5% 90.3% 88.7% 86.1%

94.7% 88.3% 90.8% 89.4% 86.9%

7.9 6.0 9.4 6.4 6.1

7.8 5.9 9.3 6.3 6.1

8.0 6.0 9.5 6.4 6.2

6,374

138,546

12,212

3,720

154,478

718

161,570

89.7%

89.5%

89.8%

7.1

7.0

7.1

Source: Admitted Patient Commissioning Data Set, Healthcare Commissioning Services; Mid-year population estimates, Office for National Statistics. Notes: [1] Based on ONS mid-year population estimates for the years 2007 to 2010, current as of September 2011. Estimates for 2010 are also used as proxies for 2011 as data for this year are yet to be published. [2] Rates are expressed per 1,000 population years at risk. [3] Based on the Wilson score method.(137) [4] Based on Byar's approximation to the Poisson distribution(138)

Chronic pain health needs assessment

West Midlands average 2SD limits 3SD Limits PCTs

Crude elective episode rate per 1,000 population years at risk

12 10 8 6 4 2 0 0

1,000,000

2,000,000

3,000,000

4,000,000

5,000,000

Population years at risk

Source: Admitted Patient Commissioning Data Set, Healthcare Commissioning Services; Mid-year population estimates, Office for National Statistics.

Figure 13. Funnel plot of crude episode rate for elective pain management in-patient procedures for West Midlands residents aged 16+ by PCT and PCT Cluster, FYs 2007/8 to 2011/12. 100

Percentage of day cases

West Midlands average 2SD limits 3SD Limits PCTs

75 0

5,000

10,000

15,000 20,000 25,000 30,000 Number of elective episodes

35,000

40,000

45,000

Source: Admitted Patient Commissioning Data Set, Healthcare Commissioning Services.

Figure 14. Funnel plot of day cases as percentage of all episodes for elective pain management inpatient procedures, West Midlands residents aged 16+ by PCT and PCT Cluster, FYs 2007/8 to 2011/12.

Chronic pain health needs assessment 67

6.11 Trends by PCT Cluster. Table 20 shows how the PCT Cluster level elective activity volumes and crude rates have changed over the five years. Arden, Birmingham and Solihull and Black Country Clusters have similar trends to that described above for the West Midlands as a whole, i.e. their episode counts and rates peaked in 2009/10 and have decreased since. This decrease has been most marked in Arden where the crude elective episode rate has dropped by a third over two years. Birmingham and Solihullâ&#x20AC;&#x2122;s rate has remained consistently above the regional average over the five years. Both Staffordshire and West Mercia have seen significant increase in their elective activity in the year 2011/12 (Figure 15).

Table 20. Crude episode rate for elective pain management inpatient procedures for West Midlands residents aged 16+ years by PCT Cluster, FYs 2007/08 to 2011/12 PCT Cluster 2007/08

Financial year 2008/09 2009/10 2010/11

2011/12

Total all years

Total elective episodes Arden Birmingham and Solihull Black Country Staffordshire West Mercia Total West Midlands residents

4,925 5,059 7,032 4,744 4,763 26,523

5,865 5,950 8,009 5,518 6,024 31,366

6,294 6,445 8,813 5,487 6,544 33,583

5,753 6,120 8,733 5,474 6,063 32,143

4,216 5,202 8,459 6,571 6,415 30,863

27,053 28,776 41,046 27,794 29,809 154,47 8

Crude elective episode rate Arden Birmingham and Solihull Black Country Staffordshire West Mercia Total West Midlands residents

7.3 5.3 8.1 5.5 4.9 6.1

8.6 6.2 9.2 6.3 6.2 7.2

9.1 6.7 10.1 6.3 6.7 7.7

8.3 6.3 10.0 6.2 6.2 7.3

6.1 5.3 9.7 7.5 6.6 7.0

7.9 6.0 9.4 6.4 6.1 7.1

Source: Admitted Patient Commissioning Data Set, Healthcare Commissioning Services; Mid-year population estimates, Office for National Statistics.

Chronic Pain Health Needs Assessment

Crude rate per 1,000 population years at risk

12 10 8 6 4 2

Arden

Birmingham and Solihull

Black Country

Staffordshire

West Mercia

West Midlands average

0 2007/08

2008/09

2009/10 Financial year

2010/11

2011/12

Source: Admitted Patient Commissioning Data Set, Healthcare Commissioning Services; Mid-year population estimates, Office for National Statistics.

Figure 15. Crude episode rate for elective pain management in-patient procedures, West Midlands residents aged 16+ by PCT Cluster, FYs 2007/8 to 2011/12.

TRENDS IN SPECIFIC PROCEDURES IN PAIN MANAGEMENT 6.12 There are a large number of specific procedures used in pain management. Using the 3digit OPCS4 codes there are 17 broad categories of operation. Data on the number of each of these procedures is shown in Table 21. The figures include all activity, i.e. for all methods of admission and all patient classifications. The vast majority of these episodes are elective activity (over 95%). The three most common procedures alone account for 80% of the activity undertaken (Figure 16). The most common procedure was a puncture of a joint with over 70,000 episodes or 43% of the activity. This includes aspiration and injection of a therapeutic substance into the joint. The second most frequent procedure was other operations on spine â&#x20AC;&#x201C; specifically these are all injections around spinal facet of spine â&#x20AC;&#x201C; with over 31,000 episodes (19%). Over 28,000 (17%) of episodes had a therapeutic epidural injection performed. The next most frequent procedures were operations on spinal nerve root (5.6%), neurostimulation of peripheral nerve (4.9%) and therapeutic spinal puncture (3.0%). 6.13 The trend in the 6 most common procedures over the 5 years is shown in Figure 17. The most notable feature is the steady increase in the frequency of puncture of the joint. Not only is it the most frequent procedure but it has increased from just under 12,000 episodes in 2007/8 to in excess of 15,000 in 2011/12, a rise of 29%.

Chronic Pain Health Needs Assessment

Table 21. Pain management inpatient procedure episodes for West Midlands residents aged 16+ years by 3-digit OPCS4 procedure code and year, FYs 2007/08 to 2011/12 OPCS4 Procedure code (3-digit) [1]

Financial year

Total all years

200708

200809

200910

201011

201112

Count

11,946

13,499

15,088

14,327

15,391

70,251

43.4%

W9 0 V54

Puncture of joint Other operations on spine

5,086

6,333

7,433

6,820

5,456

31,128

19.2%

A52

Therapeutic epidural injection

5,470

6,056

6,235

5,472

4,848

28,081

17.4%

A57

Operations on spinal nerve root

1,348

1,942

1,422

1,638

2,758

9,108

5.6%

A70

Neurostimulation of peripheral nerve Therapeutic spinal puncture

1,142

1,690

2,194

2,328

531

7,885

4.9%

847

900

1,027

1,045

1,017

4,836

3.0%

494

649

536

643

823

3,145

1.9%

504

710

470

576

674

2,934

1.8%

462

472

335

360

465

2,094

1.3%

115

465

0.3%

101

465

0.3%

Primary excision of cervical intervertebral disc Primary fusion of other joint of spine

121

428

0.3%

391

0.2%

Revisional decompression operations on lumbar spine Revisional excision of lumbar intervertebral disc Neurostimulation of brain

255

0.2%

201

0.1%

0.0%

27,738

32,706

35,141

33,705

32,492

161,782

100.0%

A54 V48 V25 V33 V52 A48 V29 V38 V26 V34 A09 V35

Denervation of spinal facet joint of vertebra Primary decompression operations on lumbar spine Primary excision of lumbar intervertebral disc Other operations on intervertebral disc Other operations on spinal cord

Excision of unspecified intervertebral disc Total all procedures

Source: Admitted Patient Commissioning Data Set, Healthcare Commissioning Services; Mid-year population estimates, Office for National Statistics. Notes: [1]

Recorded as the primary procedure within the episode.

Chronic Pain Health Needs Assessment

Operations on spinal nerve root (A57) 9108 6% Neurostimulation of peripheral nerve (A70) 7885 5% Therapeutic spinal puncture (A54) 4836 3% Other pain management procedures 10,493 7%

Therapeutic Other operations epidural injection on spine (V54) (A52) 31128 28081 19% 17%

Puncture of joint (W90) 70251 43%

Source: Admitted Patient Commissioning Data Set, Healthcare Commissioning

Figure 16. Most widely used pain management procedures (using 3-digit OPCS4 procedure code), West Midlands residents aged 16+, FYs 2007/8 to 2011/12.

W90 Puncture of joint

Count of episodes (thousands)

16 14

V54 Other operations on spine

12 10

A52 Therapeutic epidural injection

8 6

A57 Operations on spinal nerve root

4 2 0

2007/08

2008/09

2009/10 Financial year

2010/11

2011/12

A70 Neurostimulatio n of peripheral nerve

Source: Admitted Patient Commissioning Data Set, Healthcare Commissioning Services.

Figure 17. Trends in the most frequently used procedures, West Midlands residents aged 16+, FYs 2007/8 to 2011/12.

Chronic Pain Health Needs Assessment

ANALYSIS BY PROVIDER TRUSTS 6.14 Table 22 shows the pain management inpatient procedure episodes for each of the West Midlands Provider Trusts. It includes all patients treated at the Trusts, including those resident outside of the West Midlands region and excludes episodes classified as maternity and delivery episodes (as described in Methods above). There was a total of 153,891episodes to West Midlands providers of which 145,542 were elective episodes. This is nearly 9,000 fewer elective episodes than reported for West Midlands residents. This suggests a net flow of patients being treated as elective cases by providers outside the region. 6.15 Three Trusts undertook significantly larger volumes of elective activity: The Dudley Group NHS Foundation Trust (21,684), The Royal Orthopaedic Hospital NHS Trust in south Birmingham (21,921), University Hospitals Coventry and Warwickshire NHS Trust (20,811). 85.8% of elective activity across the region was done as day cases; this is slightly lower than the day case percentage for the West Midlands resident patients (89.7%). Day case percentage varied from a low of 41.5% at the University Hospitals Birmingham NHS Trust to 99.0% at South Warwickshire NHS Foundation Trust. Birmingham Womenâ&#x20AC;&#x2122;s NHS Foundation Trust had a rate of 5.3% but this was based on just 18 cases over 5 years. The distribution of the percentage of first attendances by provider trust displays over-dispersion when compared to the control limits around the regional average (Figure 14).

100 90

Percentage of day cases

80 70 60 50 40

West Midlands average 2SD limits 3SD Limits Provider Trusts

30 20 10

0 0

5,000

10,000 15,000 Number of elective episodes

20,000

25,000

Source: Admitted Patient Commissioning Data Set, Healthcare Commissioning Services.

Figure 18. Funnel plot of day cases as a percentage of all elective episodes for West Midlands provider trust patients aged 16+, FYs 2007/8 to 2011/12.

Chronic Pain Health Needs Assessment

Table 22: Pain management inpatient procedure episodes for West Midlands Provider patients aged 16+ years by Provider Trust by admission method and patient classification, FYs 2007/08 to 2011/12 Provider Trust

Emergency episodes Day cases

Elective episodes Ordinary Regular admissions attenders

Total

Other and unspecif’d episodes

Total episodes

Day case as % of elective Percent

95% CI limits [1] Lower

Upper

RNA THE DUDLEY GROUP NHS FOUNDATION TRUST

659

19,574

2,110

21,684

22,368

90.3%

89.9%

90.7%

RRJ

THE ROYAL ORTHOPAEDIC HOSPITAL NHS FOUNDATION TRUST

175

19,839

2,082

21,921

22,165

90.5%

90.1%

90.9%

RKB

UNIVERSITY HOSPITALS COVENTRY AND WARWICKSHIRE NHS TRUST

1,027

16,953

3,845

20,811

153

21,991

81.5%

80.9%

82.0%

RRK

UNIVERSITY HOSPITALS BIRMINGHAM NHS FOUNDATION TRUST

731

4,559

3,813

2,626

10,998

555

12,284

41.5%

40.5%

42.4%

RXK

SANDWELL AND WEST BIRMINGHAM HOSPITALS NHS TRUST

574

8,574

281

179

9,034

9,645

94.9%

94.4%

95.3%

RWP WORCESTERSHIRE ACUTE HOSPITALS NHS TRUST

519

8,175

175

8,363

8,900

97.8%

97.4%

98.0%

RJE

UNIVERSITY HOSPITAL OF NORTH STAFFORDSHIRE NHS TRUST

553

6,102

1,593

7,697

8,298

79.3%

78.4%

80.2%

RL4

THE ROYAL WOLVERHAMPTON HOSPITALS NHS TRUST

311

6,390

597

6,987

7,354

91.5%

90.8%

92.1%

RJD

MID STAFFORDSHIRE NHS FOUNDATION TRUST

291

6,393

349

102

6,844

7,161

93.4%

92.8%

94.0%

RR1

HEART OF ENGLAND NHS FOUNDATION TRUST

431

5,923

210

6,133

6,580

96.6%

96.1%

97.0%

RJC

SOUTH WARWICKSHIRE NHS FOUNDATION TRUST

193

5,948

6,011

6,215

99.0%

98.7%

99.2%

RBK

WALSALL HEALTHCARE NHS TRUST

487

4,724

618

5,342

5,886

88.4%

87.5%

89.3%

507

3,680

306

3,987

4,534

92.3%

91.4%

93.1%

2,730

1,264

4,002

4,138

68.2%

66.8%

69.6%

RXW SHREWSBURY AND TELFORD HOSPITAL NHS TRUST RL1 RLT

THE ROBERT JONES AND AGNES HUNT ORTHOPAEDIC HOSPITAL NHS FOUNDATION TRUST GEORGE ELIOT HOSPITAL NHS TRUST

2,877

2,956

3,042

97.3%

96.7%

97.9%

RLQ

WYE VALLEY NHS TRUST

359

2,129

206

2,335

2,737

91.2%

90.0%

92.3%

RJF

BURTON HOSPITALS NHS FOUNDATION TRUST

146

207

273

426

75.8%

70.4%

80.5%

RQ3 BIRMINGHAM CHILDREN'S HOSPITAL NHS FOUNDATION TRUST

140

145

147

96.6%

92.2%

98.5%

RLU

5.3%

0.9%

24.6%

7,093

124,918

17,680

2,944 145,542

1,256

153,891

85.8%

85.6%

86.0%

BIRMINGHAM WOMEN'S NHS FOUNDATION TRUST Total All West Midlands PCOs

Source: Admitted Patient Commissioning Data Set, Healthcare Commissioning Services. Notes: [1] Based on the Wilson score method(137).

Chronic pain health needs assessment

7 STAKEHOLDER AND CORPORATE NEEDS ASSESSMENT CHRONIC PAIN – STAKEHOLDERS The development of services for people affected by Chronic Pain is advocated by several professional, third sector and patient representative groups. 7.1 Chronic Pain Policy Coalition. Policy Connect host the Chronic Pain Policy Coalition (CPPC), a collaboration formed in 2006 with an aim to ‘unite patients, professionals and parliamentarians in a mission to develop an improved strategy for the prevention, treatment and management of chronic pain and its associated conditions’. The coalition currently lists the following organisations as its collaborators; 7.2 Medical & Nursing Colleges, and Other Societies         

The Royal College of Anaesthetists The Royal College of General Practitioners The Royal College of Nursing Royal College of Obstetricians and Gynaecologists The Royal College of Physicians British Society for Rheumatology The Faculty of Occupational Medicine The British Pain Society The British Medical Acupuncture Society

7.3 Patient Support and Representative Groups. These organisations have variable membership and scale. To assist in reviewing the likely impact of these groups, where a charitable income could be identified for 2010/11 or 2011/12, this has been indicated. (Note that this will not include income for any associated non-charitable companies).              

Action for ME - £689,333 Action on Pain - £26,929 BackCare (National Back Pain Association) - £496,521 The British Polio Fellowship - £874,232 Derbyshire Chronic Pain Support Group (COPING) – Not identified Empower – Not identified Endometriosis SHE Trust - £7,953 FibroAction - £30,512 Fibromyalgia Association UK - £45,697 The Migraine Trust - £497,752 National Lichen Sclerosus Support Group – Not identified Pain Association Scotland - £241,580 (Scottish Charitable Commission) Pain Concern - £34,917 (Scottish Charitable Commission) Pain Relief Foundation - £318,458

Chronic Pain Health Needs Assessment

     

Pelvic Pain Support Network - £12,966 Poole Endometriosis Support Group – Not identified Scleroderma Society - £194,337 Shingles Support Society - £100,941 Spinal Injuries Association - £2,164,274 Vulval Pain Society - £5,003

The coalition is funded from a variety of sources, including sponsorship from medical corporate sponsors, named as Astellas, Grunenthal, Lilly, Medtronic, Napp, Pfizer and Sanofi Pasteur MSD. The coalition campaigns against a five point manifesto which it established in 2007. It suggests that the effective approach to the management of chronic pain requires; 1. Education – integrating management of chronic pain in all professional training 2. Empowerment – to support people making decisions about their condition 3. Collaboration – to bring stakeholders together to deliver joined up patient strategy 4. Early Access – to prevent acute pain becoming chronic pain 5. Measurement – to see pain measured as a basic vital sign in patient management

CPPC hosted the first English ‘Pain Summit’ in November 2011, and published recommendations for future development of chronic pain services in July 2012(140). It made four overarching recommendations;

A. Clear standards and criteria must be agreed and implemented nationally for the identification, assessment and initial management of problematic pain. B. An awareness campaign should be run to explain the nature, extent, impact, prevention and treatment of chronic pain to the wider general and NHS community. C. Nationally-agreed commissioning guidance must be developed and agreed, describing best value care in chronic pain to reduce unwarranted variation D. A data strategy for chronic pain should be agreed through creation of an epidemiology of chronic pain working group.

The coalition identifies that, despite progress on information gathering, through the Health Survey for England and the National Pain Audit, commissioning practice varied widely, and suggested that although examples of best practice in areas from needs assessment to service delivery could be identified, there was a lack of consistency across England in the delivery of chronic pain services. 7.4 Other Organisations

Chronic Pain Health Needs Assessment

Many of the organisations within the CPPC also advocate independently for developments in services for patients with chronic pain; 7.5 British Pain Society The British Pain Society (BPS), a charitable professional organisation, represents a multidisciplinary body of doctors, nurses, physiotherapists, psychologists, occupational therapists and other healthcare and related research professionals involved in the treatment and management of pain. It delivers its charitable purposes through education and training, professional publications including treatment guidance, patient literature and participation and membership of chronic pain stakeholder groups, including those hosted by the National Institute for Health and Clinical Excellence.

The BPS has undertaken significant work on the development of pain management pathways, and has recently had two pathways published on the Map of Medicine  Initial assessment and early management of pain(141)  Spinal Pain(142) The society has also independently published draft pathways covering several other areas, and has a stated intention to progress these towards publication through Map of Medicine*. These cover neuropathic pain, chronic widespread pain and low back pain. The BPS publishes its own Pain Rating Scale, available in 17 languages, which assesses pain against intensity and distress at time of assessment and during the previous week on an 11 point scale, alongside the interference with normal everyday activities caused by pain (subjective single point assessment). 7.6 Royal College of Anaesthetists Many pain management services are led or supported by anaesthetists, and the professional college delivers the majority of its professional function to chronic pain services through the Faculty of Pain Medicine, which covers both the care of patients with acute pain and chronic pain. The Faculty publishes guidance on professional competencies for the Pain Management Specialist(143), and is supported by the college in publishing recommendations on the provision of services for Chronic Pain Management(144). The college guidance recommends that a good pain management service will offer;  Ready access for patients to a local, first class chronic pain service  A seamless service between primary and secondary care  A specialised chronic pain management services in each region for adult patients with complex pain problems *

When accessed on 25th October 2012, it was noted that the project deadline for this had elapsed. No information was identified on the future timeline for final publication of these additional pathways.

Chronic Pain Health Needs Assessment

 Specialised chronic pain management services in each region for children and young people with complex pain problems with a requirement to work with children and their families  Established links between acute and chronic pain management services within each hospital to enable patients with pain who present acutely and whose symptoms do not resolve to be managed appropriately as an outpatient  Co-operation between chronic pain management and palliative care services within hospitals and the community  Provision of appropriate time for direct clinical care for consultants in pain medicine, allied health professionals, managers and support staff  Appropriate accommodation, facilities and equipment in accordance with best practice recommendations  Formal links between hospitals on a regional basis so that a comprehensive range of treatments can be offered to all patients who need them  Provision of pain management programmes (PMP) that promote restoration of physical and psychological function, encourage self care and decrease use of healthcare resources  A robust 24/7 on-call system with support from other disciplines (e.g. spinal/ neurosurgery, radiology, microbiology) if neuro-modulation techniques are used  Sufficient funding to enable the service to achieve required targets and quality standards  Continuing professional development of all staff  Equity of access and service provision for all patients

The Royal College of Anaesthetists also includes Chronic Pain services within its audit criteria(145). These offer specific and substantial audit criteria against which Chronic Pain Services can be assessed. Standards include;  Management of patients with repeat admissions for chronic pain  Availability and resourcing of core chronic pain services  Long term use of opioid analgesia in chronic non-malignant pain

Each standard is accompanied by specific audit criteria and suggested data collection sources. For example, in the assessment of management of patients with repeat admissions, the college propose five standards;

    

Reduce re-admission rates for non surgical pain. Develop resources to manage non acute pain effectively. Reduce length of stay related to acute exacerbations of chronic pain. Development of shared care amongst specialties. Reduction of medication-related adverse events.

Standards and targets for best practice are also proposed.

Chronic Pain Health Needs Assessment

The priority focus of the college is in delivering training for anaesthetists in the techniques of managing chronic pain, including best practice guidance on specific procedures. Outside of its participation on policy and steering groups, and the above references, no further documents were identified on specific advocacy for future developments in chronic pain services. 7.7 Spinal Injuries Association The Spinal Injuries Association is, by charitable income, a major stakeholder. However, review of the online document archive did not demonstrate any relevant, contemporary publications outside of the association's contribution to the Chronic Pain Policy Coalition. 7.8 International Association for the Study of Pain (IASP) The IASP is one of the international bodies connected with chronic pain, that significantly contributes to UK practice and treatment. Three outputs are particularly relevant in the commissioning and delivery of chronic pain services; 1. The 'Desirable Characteristics of National Pain Strategies'(146). These are recommendations by the IASP to assist in the construction of overarching strategy documents linked to Chronic Pain. The critical recommendations are;  Access to pain education for health professionals and the general population  Coordination of the care system to ensure timely access to the right support  A quality improvement program to address access and standards of care  A reasonable proportion of direct and dedicated funding for pain research. The same guidance also identifies critical success factors around effective epidemiology, clear and available service descriptions, cross-stakeholder working, and strong timescales for delivery. 2. IASP also make 'Recommendations on Pain Treatment Services(147) ', which superseded specific guidance for pain treatment facilities(148) in 2009. This guidance provides broad behaviours for chronic pain services, including the need for interdisciplinary communication, co-ordinated and programmed care delivery, and a commitment to advancing and improving services. 3. Finally, IASP produces a detailed taxonomy(149) for the classification of pain by type and location. This taxonomy is not currently linked to the ICD-10 or NHS classification systems. 7.9 Patient Support Groups No standardised networks or central co-ordination of support groups for chronic pain services were identified. Specific subgroups of patients, such as those with Arthritis, Back pain or Fibromyalgia are served by established disease specific support networks, but chronic pain per se has no similar national coverage.

Chronic Pain Health Needs Assessment

Organisations such as Action for Pain, Action on Pain and Pain Concern maintain websites and discussion groups, but do not identify with a specific local footprint. There is no evidence of systematic professional support on these websites, with the dominant focus being on peer advice and information sharing. Pain Concern are identified as PPE representatives on the development of several national guidelines and strategies connected with pain services, but do not have clear advocacy aims listed within their charitable objectives. Neil Betteridge, an independent policy analyst and consultant, and previous chief executive of Arthritis Care, provides the patient and public representative on the CPPC executive committee. The CPPC does not include a clear single patient representative body within its membership. The West Midlands NHS Local website does not list any support groups provided outside the context of direct NHS care, and the West Midlands Commissioning Support Unit was not made aware of any local groups during the conduct on the needs assessment. Website and document review of the other organisations within the CPPC did not identify further relevant substantiated policy documents relevant to the advocacy and development of Chronic Pain services. The Patient Association, not directly connected with the CPPC, has also contributed to the chronic pain policy debate through the 2010 ‘Public Attitudes to Pain’ report(150). This patient focussed survey concluded with the Patient Association calling on the Government and healthcare professionals to take action to  Establish a clear care pathway for pain services in the NHS and recognise pain as a disease in its own right  Ensure that patients have access to all the information they require to make informed and complete decisions about the care pathway  Provide further education for healthcare professionals on pain services  Ensure that NICE guidelines on Medicines Adherence are followed by healthcare professionals

CHRONIC PAIN – SERVICE DELIVERY 7.10 A survey of NHS provider units in the West Midlands region was conducted by the West Midlands Commissioning Support Unit as part of the healthcare needs assessment. This included a standardised set of questions (shown in the Appendix), and was followed by an electronic reminder where no response was received. Nine sufficient responses were received, and these results can be seen summarised in Table 23. An original copy of the questionnaire is included within the appendices.

Chronic Pain Health Needs Assessment

7.11 All providers that responded offered a formal chronic pain management service, led by the department of Anaesthetics, and delivering a multi-disciplinary clinic. Some services have dedicated staff working full time for the chronic pain service, whilst others shared team members with the in-hospital acute pain service, or with wider multidisciplinary teams, particularly physiotherapy, psychology and occupational health. Some services used referral to other departments to complete the multi-disciplinary team The number of clinical sessions varied widely, as did the number of doctors and senior specialist nurses supporting the service. Where patient numbers were stated, these again showed substantial variation, and were not directly correlated with the number of clinical sessions held. An array of interventions were offered. Commonly offered interventions reported through the survey included;         

TENS Anticonvulsants (Gabapentin, Carbamazepine) Antidepressants Analgesic, Steroid and Anaesthetic Injections Back Injections Intra-articular injections Nerve Ablation Psychotherapy Cognitive Behavioural Therapy

Interventions mentioned infrequently included;             

Ultrasound Low Level Laser Therapy Facet Denervations Trigger Injections Percutaneous chordotomy Visco-supplementations Acupuncture Pain Management Programmes Spinal Cord Stimulation Sacral Nerve Stimulation Capsaicin Patch Therapy Intrathecal Drug Delivery and Injections Botulinum A Injections

Note that these were free text responses, and organisations may only have reported certain therapies, such as those seen as advanced, controversial, or essential to the delivery of a service. Individual Funding Requests were reported by four of the nine responders, and included applications for funding to out of region complex pain services.

Chronic Pain Health Needs Assessment

7.12 Summary of Service Design & Delivery by Trust Table 23: Summary of Questionnaire responses by trust Trust

HoE

ROH

SWBH

S Warks

UHCW

DGOH

RJAH

Burton

UHNS

Formalised Service

Yes

Service Specification

Yes

Some

Yes

Some

4.5

Consultants

Other Doctors

Nurses

2-3

Unknown

Psychology Support

Dedicated

By Referral

None Stated

Dedicated

None Stated

Dedicated

None Stated

Physiotherapy Support

Dedicated

Cross Cover

Through Main Dept

None Stated

Dedicated

None Stated

Dedicated

Dedicated*

3500

2075

2500

Unknown

1500

Unknown

600

Unknown

Yes

New Service

*0.1 WTE only

Clinical Sessions (approximate number)

Referrals (Approximate) NPA Contributor

Notes

Chronic Pain Health Needs Assessment

Nurses also cover acute pain service

SupraRegional 3o IFRs

COMMISSIONING CHRONIC PAIN SERVICES 7.13 Chronic pain services have previously been commissioned through Primary Care Trusts, with some particular services commissioned through the West Midlands Specialised Commissioning Team. The implementation of the Health and Social Care Bill means that the majority of commissioning responsibility for these services is being transferred to Clinical Commissioning Groups, with specialist services now becoming the responsibility of the National Commissioning Board. The West Midlands Commissioning Support Unit has encountered difficulties in identifying leads in either sender or receiver organisations, at both local and regional level, who have operational knowledge of the commissioning of these services, or with sufficient resource to support the unit in identifying the scope of the existing commissioned service. It is therefore only possible to present ‘cameos’ of the current chronic pain commissioning structure;  Service specifications, with varying degrees of detail, do exist for the majority of services. However, these largely focus on necessary targets, such as waiting times and routes of access, and do not provide precise descriptions of the scope of a chronic pain service.  Chronic pain services are largely accessed through General Practice services, although where community pain teams exist, there may be routes of direct referral to an acute provider service  Few commissioners or providers were aware of specific commissioned pathways. Where these were referenced, they were direct transcriptions or copies of national Map of Medicine pathways. No alternative pathways covering other chronic pain conditions were identified.  As well as routinely commissioned services, commissioners made reference to Individual Funding Requests, particularly around complex therapeutic interventions such as neurostimulators.  There was evidence that many commissioners currently included certain procedures used for the relief of pain within lists of procedures of limited clinical value, or for which specific eligibility criteria had to be met. This was most consistently applied in relation to certain joint injection procedures.  An example was identified within a public health pharmacy team of clear guidance on prescribing for chronic pain relief. However, work to connect this to referral pathways, and non-pharmacological interventions had been suspended whilst the new commissioning responsibilities were established.  Worcestershire was the only West Midlands area identified to have a localised pathway listed on Map of Medicine. This addressed both musculoskeletal and neuropathic pain, focussing on management prior to referral to the specialist pain clinic.  Providers reported varying qualifying criteria for access to their chronic pain service. Some reported pre-screening by primary care trusts, some used timeframe criteria (for example, at least three months of pain), and others triaged referrals on a case by case basis, either undertaken by medical or senior nursing staff.  Two Clinical Commissioning Groups (CCGs) stated that they were developing more community focussed pathways, particularly around low back pain, but

Chronic Pain Health Needs Assessment

this work was at draft stage, and further detail was not yet available. Four other CCGs contacted were as yet unable to provide a contact for commissioning of these services and referred back to their respective Primary Care Trusts. 7.14 The West Midlands Primary Care Trusts have also previously commissioned some complex services through the West Midlands Specialised Commissioning Team. These were defined by the Specialised Services National Definitions Set (SSNDS), specifically SSNDS 31(151) which established the scope of specialised services for Chronic Pain. These specifically relate to the commissioning of certain denervation and chordotomy procedures, both surgical and radiofrequency, and implantable neuro-stimulation techniques. 7.15 From April 1st, 2013, the responsibility for commissioning of these procedures will become the responsibility of the National Commissioning Board. Clinical Reference Groups (CRGs) have been established to construct and assure service specifications for identified services, including some chronic pain services. However, these service specifications have not yet been released into the public domain. The full list of CRGs can be viewed at http://specialisedcommissioning.com/clinical-reference-groups/ Key CRGs for the development of chronic pain services include;  Specialised Pain CRG  Complex Spinal Surgery CRG  Adult Neurosurgery CRG Final outputs from these CRGs are expected by April 2013, and will inform the commissioning pathways for more specialised interventions for patients with chronic pain. Draft consultation versions of the central service specifications, which will be used both within the National Commissioning Board and the NHS standard contract, are expected by December 2012. 7.16 The Specialised Pain CRG is still at an early stage of development, but the clinical panel has been established. It is chaired by Dr Andrew Baranowski, a pain specialist working at University College London Hospitals, with commissioning support led by Joan Ward from NHS South Central and public health input from John Harris, a public health practitioner in London. The group also has Regional Representatives from the four England 'old-SHA' sectors, and PPE Members from Pain Concern and the Chronic Pain Policy Coalition. Invited Members also attend the group, representing Psychology, Physiotherapy, Cancer Services, Academic Interests, British Pain Society, Faculty of Pain Medicine, the RCGP and the Chronic Pain Coalition.

Chronic Pain Health Needs Assessment

No information was available on the scope or timeline of potential products of this CRG(152). The WMCSU has however been able to review an early draft of the chronic pain service specification. This proposes the following commissioning model for chronic pain services. No detailed pathways have yet been proposed.

Community Care

Secondary

Tertiary

Contracted by CCGs Non-Specialised

Specialised Activity

Activity referred into the tertiary setting but not specifically specialised

Identified by using: •Specific clinic ID •OPD diagnostic code •Patient Register •Inpatients using OPCS/ICD 10. If not sensitive enough see following model

Contracted by CCGs

Contracted by NHS

The proposed pathway identifies that referrals will only be made from secondary or tertiary care services into very specialised interventions and conditions, of which the service specification identifies between six and ten that may already meet criteria to be considered very specialised. It was noted that the draft service specification did not yet provide detail on how tertiary activities would be identified in data streams from non-specialised activity delivered in a concurrent setting. The early draft specification proposes that minimum standards will be defined by the British Pain Society, Faculty of Pain Medicine, Royal College of Anaesthetists and International Association for the Study of Pain, with pathways parallel to those proposed by British Pain Society, and already discussed above.

MEASURING OUTCOMES 7.17 Prior discussions with local providers identified an array of assessment tools in use, including Visual Analogue Scores (Usually 0-10 range), Hospital Anxiety and Depression Scores, McGill questionnaire, 5th Vital Sign, and the Rowland Morris Scoring Systems. The draft service specification highlights a series of proposed

Chronic Pain Health Needs Assessment

metric for monitoring clinical progress and assessing clinical outcomes; again, these are unconfirmed and subject to further substantial consultation;     

Brief Pain Inventory (short form) SF-12 Quality of Life Score PHQ-9 Depression Assessment Monitoring of employment/education/training status Patient Global Impression of Change

Service monitoring metrics proposed include;  Percentage of patients assessed within 3 months from referral  Percentage of patients entering multi-disciplinary treatment pathways within 6 weeks following assessment  Percentage of patients discharge to primary care within 12 months from referral.

It should be noted that these proposed measures are not representative of those used in research methodologies. In particular, the Cochrane Collaboration Pain, Palliative and Supportive Care (PaPaS) review group have considered potential outcome measures for use in the evaluation of evidence for systematic review(153,154,155) and support the adoption of the IMMPACT assessments in this context. The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) provide a set of outcomes which it deems meaningful in research, and to patients. They also recommend certain scales for use in the assessment of pain.

RECOMMENDED CORE OUTCOME MEASURES IN RESEARCH 

    

Pain o o o

11 point (0-10) numerical rating scale of pain intensity Usage of rescue analgesics Categorical rating of pain intensity (none/mild/moderate/severe) where numerical ratings may be problematic Physical Functioning o Multidimensional Pain Inventory Interference Scale o Brief Pain Inventory interference items Emotional Functioning o Beck Depression Inventory o Profile of Mood States Participant ratings of global improvement and satisfaction with treatment o Patient Global Impression of Change Symptoms and adverse events - passive capture of spontaneously reported adverse events and symptoms and use of open-ended prompts Participant Disposition (in line with CONSORT guidance)

Chronic Pain Health Needs Assessment

The IMMPACT group identify that the following responses to pain interventions are significant within trial groups for Pain;   

At least 50% pain reduction* or At least 30% pain reduction Absolute score of 30/100 or less (no worse than mild pain) Patient Global Impression of very much improved

*In the latest update to IMMPACT it is suggested growing evidence favours an outcome of a 50% reduction in pain. No minimum level for improvements in function are set by the IMMPACT group.

TAXONOMY OF CHRONIC PAIN SERVICES 7.18 Based on the information that was received, and through the treatments identified in the epidemiological and literature reviews, taxonomy for the delivery of Chronic Pain services has been constructed. This hierarchy demonstrates that the majority of care is delivered through self care, and primary care services, but with increasingly complex investigations and interventions deployed through secondary care, and ultimately highly specialised tertiary or quarternary care, limited to a few specialist centres.

Chronic Pain Health Needs Assessment

7.19 Prior to the current NHS reconfiguration, the SSNDS defined the specialist pain interventions using the following ICD-10 and OPCS-4 codes; OPCS OPCS-4.5 Category OPCS-4.5 Sub-category

Yes Maybe Comments

A365 Other operation on Denervation of trigeminal nerve (v) cranial nerve

A472 Other destruction of Radiofrequency controlled thermal spinal cord destruction of spinothalamic tract

only in conjunction with a pain ICD code

A473 Other destruction of Percutaneous chordotomy of spinal spinal cord cord

only in conjunction with a pain ICD code

A483 Other operations on Insertion of neurostimulator adjacent x spinal cord to spinal cord

for tertiary treatment of neuropathic pain

A484 Other operations on Attention to neurostimulator adjacent x spinal cord to spinal cord NEC

for tertiary treatment of neuropathic pain

A543 Therapeutic spinal puncture

Implantation of intrathecal drug delivery device adjacent to spinal cord

only in conjunction with a pain ICD code

A544 Therapeutic spinal puncture

Attention to intrathecal drug delivery device adjacent to spinal cord

only in conjunction with a pain ICD code

A545 Therapeutic spinal puncture

Removal of intrathecal drug delivery device adjacent to spinal cord

only in conjunction with a pain ICD code

A701 Neurostimulation of Implantation of neurostimulator into peripheral nerve peripheral nerve

only in conjunction with a pain ICD code

A702 Neurostimulation of Maintenance of neurostimulator in peripheral nerve peripheral nerve

only in conjunction with a pain ICD code

A703 Neurostimulation of Removal of neurostimulator from peripheral nerve peripheral nerve

only in conjunction with a pain ICD code

A708 Neurostimulation of Other specified neurostimulation of peripheral nerve peripheral nerve

only in conjunction with a pain ICD code

Radiofrequency controlled thermal V481 Denervation of spinal facet joint of denervation of spinal facet joint of vertebra cervical vertebra

for tertiary treatment of spinal pain

Chronic Pain Health Needs Assessment

Denervation of spinal facet joint of V482 Denervation of spinal facet joint of cervical vertebra NEC vertebra

for tertiary treatment of spinal pain

Cognitive behavioural therapy by X662 Cognitive behavioural therapy multidisciplinary team

requires ICD 10 code : where CBT given as part of an intensive in-patient rehabilitation programme

ICD ICD Category

ICD Sub Category

Yes

Maybe

G441 Other headache syndromes

Vascular headache NOC

G521 Disorders of other cranial nerves

Disorders of glossopharyngeal nerve

G564 Mononeuropathies of upper limb

Causalgia

G570 Mononeuropathies of lower limb

Lesion of sciatic nerve

G572 Mononeuropathies of lower limb

Lesion of femoral nerve

G574 Mononeuropathies of lower limb

Lesion of medial popliteal nerve

G579 Mononeuropathies of lower limb

Mononeuropathy of lower limb, unspecified

G580 Other mononeuropathies

Intercostal neuropathy

G601 Hereditary and idiopathic neuropathy Refsum's disease

Neuropathy in association with G602 Hereditary and idiopathic neuropathy hereditary ataxia

G603 Hereditary and idiopathic neuropathy Idiopathic progressive neuropathy

Other hereditary and idiopathic G608 Hereditary and idiopathic neuropathy neuropathies

Hereditary and idiopathic G609 Hereditary and idiopathic neuropathy neuropathy, unspecified

G611 Inflammatory polyneuropathy

Serum neuropathy

G619 Inflammatory polyneuropathy

Inflammatory polyneuropathy, unspecified

Chronic Pain Health Needs Assessment

G620 Other polyneuropathies

Drug-induced polyneuropathy

G622 Other polyneuropathies

Polyneuropathy due to other toxic agents

Other disorders of peripheral nervous Other disorders of peripheral G64X system nervous system

R201 Disturbances of skin sensation

Hypoaesthesia of skin

R203 Disturbances of skin sensation

Hyperaesthesia

It should be noted that this classification system is known to have flaws. Specialised Services specifically note that; â&#x20AC;&#x153;As with other specialised services there are difficulties with the current ICD-10 classification system because it does not identify severity or extent of disability and hence cannot distinguish between complex cases of pain treated by specialist pain management centres services and those treated by local hospitals. The OPCS codes for pain management were extensively reviewed during 2003- 2005 and have continued to be refined since then. The use of flags and co-morbidity data has produced more refined HRGs which better distinguish between local nonspecialised and specialised services for ostensibly similar procedures. If new treatments for pain arise then new OPCS codes are sought.â&#x20AC;?

PATHWAYS FOR CHRONIC PAIN PATIENTS 7.20 This taxonomy, alongside the service information that could be derived locally, and from the evidence reviews, was then used to construct patient pathways to describe the potential patient journeys for those with chronic pain. Note that it is possible to travel through the pathway several times, taking different routes at different times, and also that not all services may be available or commissioned in all areas. The following pages show the pathways of care; 1. 2. 3. 4. 5.

All potential pathways Those managed through primary care Those managed through a community chronic pain service Those managed through a hospital chronic pain service Those managed through a disease specific pathway

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8 RAPID EVIDENCE REVIEW OF THE EFFECTIVENESS OF INTERVENTIONS FOR CHRONIC PAIN. OBJECTIVE 8.1 To conduct a rapid review of the evidence for the effects and effectiveness of interventions for chronic pain, including chronic low back pain. 8.2 Two key clinical practice guidelines on the diagnostic assessment and management of low back pain have been published, one by NICE(156) the other jointly by the American College of Physicians and American Pain Society(157). Both guidelines are supported by systematic reviews of the evidence. Where relevant, some of the findings of the guidelines have been appraised and included in this rapid evidence review. A more comprehensive overview of their main recommendations are presented in Appendix ??

METHODS 8.3 Criteria for considering studies. Types of studies Systematic reviews and evidence based guidelines published in English from 2007 onwards. Types of participants. Adults from ages 18 to 70 years with chronic pain persisting for three months or longer, including chronic low back pain. Papers which included participants with cancer pain, postoperative pain or pain associated with acute trauma were excluded. Types of interventions Any intervention. Types of outcomes Primary outcome: Pain, with at least 50% pain reduction on the visual analogue scale and better management of pain. Secondary outcome: Adverse events.

SEARCH METHODS FOR IDENTIFICATION OF STUDIES 



Bibliographic database searches: a systematic literature search were undertaken in the Cochrane Library (all databases) 2011 Issue 4 (chronic pain); 2012 Issue 2 (back pain), MEDLINE (OVID) 1948 – Nov week 3 2011 (chronic pain); 1948 – May 2012 (back pain), EMBASE (OVID) 1980 – 2011 week 48 (chronic pain); 1980 – May 2012 (back pain), TRIP Database and the ARIF Database of Systematic Reviews. Where appropriate a filter for systematic reviews was applied to the searches. PROSPERO was searched to identify ongoing systematic reviews.

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The searches were limited to papers written in English and those published from 2007 onwards. Retrieved publications were entered into a Reference Manager database. Full details of the search strategies can be found in Appendix ??

DATA COLLECTION AND ANALYSIS 8.4 Selection of studies. Titles and abstracts of references were screened by one reviewer. Any uncertainties were resolved with a second reviewer. The full text of the articles was retrieved where it was unclear whether or not the review was to be included. 8.5 Data extraction and management. A data extraction table was devised jointly by two reviewers which included author of the paper, year of publication, type of study, population, intervention, comparator, outcome, follow-up and results. Data were extracted by one reviewer and put into Summary of Findings tables. Uncertainties were resolved with the second reviewer. 8.6 Methodological quality assessment. The methodological quality of the included references for systematic reviews was independently assessed by two reviewers, using the PRISMA checklist for reporting bias and AMSTAR for critical appraisal. The quality of guidelines was assessed using GRADE and completeness of reporting using the AGREE checklist. The Oxford Centre for Evidence Based Medicine grading system was used to rate the level of evidence for each included systematic review:

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RESULTS MANUAL THERAPY 8.7 This category of interventions comprises manipulation and mobilisation in chronic neck pain, and patellar taping and bracing for chronic knee pain. Two good quality systematic reviews were identified(158,159) and the findings are summarised in Appendix 1 The first review is a Cochrane Review and as such is an authoritative summary of the present state of the evidence. The review evaluated manipulation or mobilisation techniques in acute, sub-acute or chronic neck pain. The second review evaluated manual therapy combined with exercise in neck pain with or without radicular symptoms or cervicogenic headache. 8.7.1

Conclusions. While the estimated effects of manipulation or mobilisation techniques in neck pain look impressive the quality of evidence is poor. Moderate quality evidence supports this treatment combination for pain reduction and improved quality of life over manual therapy alone for chronic neck pain; and suggests greater short-term pain reduction when compared to traditional care for acute whiplash. Evidence regarding radiculopathy was sparse.

8.7.2

Implications for practice. Manipulation or mobilisation techniques in neck pain should be available for those patients who chose to have it. Manual therapy combined with exercise in neck pain could be made available to patients.

PHARMACOLOGICAL PROCEDURES 8.8 Pharmacological procedures include antipsychotics, antidepressants, NSAIDs, opioids, anti-epileptic drugs, capsicum pain plasters, anaesthetics, and cannabinoids. Fifteen systematic reviews were identified which looked at a range of pharmacological interventions(160,161,162,163,164,165,166,167,168,169,170,171,172,173,174) and the findings are summarised in Appendix 2 Antipsychotics. One medium to good quality review (160) evaluated antipsychotics for chronic pain. The authors concluded that data was limited, most trials only studied small patient samples and further research was required. Anti-depressants.

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Three recent good quality reviews evaluated anti-depressants (161,162,163). Overall, the reviews showed that there is strong evidence for the use of antidepressants in chronic pain management. Topical treatments. A Cochrane Review (164) looked at topical rubefacients containing salicylates or nicotinamides and found that the evidence was limited by the quality and size of the available studies. Opioids. The effectiveness of opioids was investigated in three reviews which were assessed as either medium or good quality (165,166,167). The evidence for the use of opioids for short-term treatment was reasonable for older patients without comorbidity, with frequent surveillance for adverse effects (165). Overall, however, the results of all three reviews indicated that the evidence base was poor and results were based on weak, positive evidence. Cannabinoids One good quality review looked at cannabinoids for non-cancer chronic pain (168). Results showed there is evidence that cannabinoids are safe and modestly effective in neuropathic pain with preliminary evidence of efficacy in fibromyalgia and rheumatoid arthritis. However, further large studies of longer duration examining specific cannabinoids in homogeneous populations are needed before firm conclusions can be drawn. Anticonvulsives Six good quality reviews investigated anticonvulsive/ antiepileptic drugs (169,170,171,172,173,174). Three were Cochrane Reviews (169,170,174) . One Cochrane Review (174) concluded that Gabapentin is effective for neuropathic pain however pain relief may vary between pain conditions and dose. Another (170) found Carbamazepine effective but the quality of included studies was poor. A third found that Lamotrigine was not effective(169). 8.8.1

Conclusions. Evidence for the use of antipsychotics was weak. There is strong evidence for the effectiveness of anti-depressants in chronic pain management. The evidence for the use of topical treatments (rubefacients) is limited. The evidence base for opioids was poor and results were based on weak, positive evidence. Cannabinoids are modestly effective in neuropathic pain with preliminary evidence of efficacy in fibromyalgia and rheumatoid arthritis. However, further large studies of longer duration examining specific cannabinoids in homogeneous populations are needed before firm conclusions can be drawn. Antiepeliptic drugs have either indeterminate or limited effect.

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Results from three Cochrane reviews suggest varying effectiveness of anticonvlusives. One (174) concluded that Gabapentin is effective for neuropathic pain however pain relief may vary between pain conditions and dose. Another (170) found Carbamazepine effective but the quality of included studies was poor. A third found that Lamotrigine was not effective. 8.8.2

Implications for practice. Lamotrigine does not have a significant place in therapy and should not be commissioned as treatment for any type of chronic pain. Carbamazepine treatment should be commissioned but only for selected patients with neuropathic pain. Gabapentin should be commissioned for selected patients. The use of antidepressant ( tricyclic antidepressants â&#x20AC;&#x201C;TCAs, and serotonin re-uptake inhibitors - SSRIs) should be included as part of the pain service.

PATIENT EDUCATION. 8.9 Therapeutic patient education was investigated in one recent, good quality Cochrane review(175). Patients included those with neck pain associated with whiplash or nonspecific and specific mechanical neck pain with or without radiculopathy or cervicogenic headache. Summaries of findings are presented in Appendix ?? 8.9.1

Conclusion. Effectiveness for educational interventions for neck pain, including advice to activate, advice on stress-coping skills, workplace ergonomics and self-care strategies has not been shown.

8.9.2

Implications for practice. The evidence available does not support the commissioning of education based interventions for neck pain.

PHYSICAL TREATMENTS 8.10 This includes laser therapy, therapeutic ultrasound, traction, and transcutaneous electrical nerve stimulation (TENS). Summaries of findings are in Appendix ?? Seven systematic reviews investigated physical treatments (176,177,178,179,180,181,182). With two exceptions (177,181), all were of either medium or good quality. Findings are summarised in Appendix ?? Two reviews investigated low level laser therapy (LLLT) (177,183); one (183) for chronic neck pain, the other (177) for neck pain and carpal tunnel syndrome. Although the reviews showed moderate statistical significance for efficacy of LLLT for chronic pain, treatment should be regarded as experimental due to poor methodological quality and variability of results and small sample size. Ultrasound for shoulder pain was investigated in one medium to good quality review

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(Alexander 2010). It showed that ultrasound had an indeterminate effect. One good quality Cochrane review looked at traction for neck pain (Graham 2008). It found no evidence from RCTs supported or rejected use of either continuous or intermittent traction for neck pain. Patellar taping and bracing was investigated in one good quality review(180) . It found evidence for medially-directed force on the patella and limited evidence to demonstrate efficacy of patellar bracing. However, outcomes were limited by the presence of high heterogeneity between study outcomes and significant publication bias. H wave electrical stimulation for neuropathic pain and soft tissue inflammation was reviewed by (181). The review was of poor quality and based on uncontrolled studies therefore little reliance can be based on the reported beneficial effect of H-wave device. One good quality review(182) investigated physical rehabilitation interventions for nonspecific low back pain (LBP). Overall evidence from RCTs showed effectiveness of treatments was low. The clinical effect of back school, LLLT, patient education, massage, traction, superficial heat/cold, and lumbar supports is not clear due to insufficient data. Only MDT, exercise and BT have some effect on pain intensity and disability, thus only these three interventions should be provided as conservative treatments in daily practice in the treatment of chronic LBP. The NICE guideline (156) makes the following recommendations for low back pain: consider offering a course of manual therapy, including spinal manipulation, comprising up to a maximum of nine sessions over a period of up to 12 weeks; consider offering a structured exercise programme tailored to the person which should comprise up to a maximum of eight sessions over a period of up to 12 weeks; offer a group supervised exercise programme in a group of up to ten people; a one-to-one supervised exercise programme may be offered if a group programme is not suitable for a particular person. 8.10.1 Conclusions Low level laser treatment for chronic pain should be regarded as experimental due to poor methodological quality and variability of results and small sample size. Ultrasound had an indeterminate effect, however, it would be premature to conclude that this treatment is ineffective. More research is required. Further well conducted RCTs to determine efficacy of traction for neck pain are required. Recommendations cannot be made with the available evidence. Evidence was found for medially-directed force on the patella and limited evidence to demonstrate efficacy of patellar bracing. However, outcomes were limited by the presence of high heterogeneity between study outcomes and significant publication bias.

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Only MDT, exercise and behavioural therapy have some effect on pain intensity and disability in chronic low back pain, thus only these three interventions should be provided as conservative treatments in daily practice in the treatment of chronic LBP.

8.10.2 Implications for practice. Only MDT, exercise and behavioural therapy have some effect on pain intensity and disability in chronic low back pain, thus only these three interventions should be provided as conservative treatments in daily practice in the treatment of chronic LBP. Consideration should be given for commissioning manual therapy (including spinal manipulation) and structured exercise programmes, either in a group or on a one-toone basis for low back pain.

BEHAVIOURAL (BT) AND COGNITIVE BEHAVIOURAL THERAPY (CBT) 8.11 Four good quality systematic reviews(184,185,186,187) and a good quality NICE guideline(156) (ref to guidance and supporting review) were identified and their findings are presented in Appendix ?? The review by Eccleston(188) is a Cochrane review which evaluated the effectiveness of psychological therapies on pain, disability and mood. It found that overall there is lack of evidence for BT, except for pain immediately following treatment, when compared with â&#x20AC;&#x2DC;treatment as usualâ&#x20AC;&#x2122;. CBT has some small positive effects for pain, disability and mood. There is insufficient data on quality or content of treatment to investigate their influence on outcomes. Overall, CBT and BT may have a positive effect on altering mood outcomes but the results were not statistically significant. Another Cochrane review (187) investigated behavioural therapy (respondent, operant and cognitive, behavioural therapy) plus physiotherapy, behavioural therapy plus inpatient rehabilitation for chronic back pain. For patients with back pain, there is moderate quality evidence that in the short-term, operant therapy is more effective than waiting list and behavioural therapy is more effective than usual care for pain relief, but no specific type of behavioural therapy is more effective than another. In the intermediate to long-term, there is little or no difference between behavioural therapy and group exercises for pain or depressive symptoms. Macea (185) investigated the effectiveness of web-based behavioural interventions on chronic pain. Results of this meta-analysis suggest that web-based interventions for chronic pain effect are associated with small reductions in pain in the intervention group compared with waiting-list control groups however the effect is weak and uncertain. The review by Hoffman (186) which looked at psychological therapies for chronic low back pain found there was a significant reduction in pain intensity and depression in

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favour of CBT. However there were concerns about the poor quality of the included RCTs. The NICE guideline (156) focused on CBT compared with self care (information package or a book on back pain) for low back pain. The evidence for effectiveness was provided by two RCTS. One found no significant difference between groups in terms of pain or fear. The other found: a greater reduction in average pain intensity for the self-care group, but difference was significant only at 6 months; significantly lower fearavoidance scale scores in the self-care group at all follow-up times; significantly less disability in the self-care group at 3 months but not at 6 or 12 months and no more favourable mental health outcomes in self-care group.

8.11.1 Conclusions. The Cochrane review (189) found that CBT and BT have weak effects in improving pain. Both CBT and BT interventions may be effective in altering mood outcomes and the effect may be maintained at 6 months.

8.11.2 Implications for practice. The evidence for behavioural therapies in isolation is weak and is not sufficient to commission these services as individual interventions, however, there is a role for CBT as part of a comprehensive multi-disciplinary programme. In view of the small effect and the likely bias, web-based behavioural therapy should not be commissioned. CBT may be considered for chronic low back pain but the quality of RCTs examining its effectiveness should be borne in mind.

INVASIVE PROCEDURES 8.12 Twenty three systematic reviews were identified which looked at a range of invasive procedures (176,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208, 209,210,211). Also two NICE Interventional Procedures Guidelines, IPG 300 (212) and IPG 357(213) and one NICE clinical guideline (156) were identified. The findings are summarised in Appendix ?? Radiofrequency thermal ablation. A good quality Cochrane review (206) looked at radiofrequency ablation sympathectomy for neuropathic pain and complex regional pain syndrome. It concluded that there is little evidence on sympathectomy (one small RCT met the inclusion criteria of the review). Intrathecal drug therapy. Two medium/good quality reviews investigated intrathecal drug therapy for chronic pain

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(195,201). Hayek (195) found modest improvements in patient reported pain scores however included studies were poorly reported. The results of the review by Patel (201) were based on four observational studies of which two showed positive results for short and long-term pain relief. However, the results should be treated with caution given the low quality of the studies and the lack of RCTs. Nerve blocks. Nerve blocks and local anaesthesia for chronic pain was investigated in a good quality review by Vlassakov 2011. All reviewed articles were single case reports or case series so no reliable conclusion could be drawn concerning the effectiveness of nerve blocks with local anaesthetics in neuralgia. Cervical epidural injections. A medium/good quality review by Benyamin 2009 (211) reviewed the evidence for cervical epidural injections for whiplash related neck pain. A significant effect was observed in relieving chronic intractable pain of cervical origin and providing long-term relief. Local analgesia. A medium/ good quality review looked at local analgesia for chronic stump pain and PLP (critical ischaemia of peripheral vascular disease) (209). It would appear that there is no robust evidence to support the use of pre-emptive analgesia to minimise risk of chronic pain after amputation for critical ischaemia of peripheral vascular disease. Facet joint injections. Two reviews looked at facet joint injections for chronic low back pain. One, a good quality Cochrane review (205) found insufficient evidence to support use of injection therapy in subacute and chronic low back pain, but it may be beneficial to a subgroup of patients who may respond to a specific type of injection therapy. The other review (192), of medium/good quality, concluded that lumbar facet joint and radiofrequency neurotomy are effective but lumbar intra-articular injections are likely to be ineffective. The NICE guideline (156) included patients with chronic back pain. The findings, based on the one RCT which met the inclusion criteria of the review were that injections are of little value in treating chronic low back pain. Botulinum Toxin (BoNT) Five good quality reviews (196,198,199,204,210) investigated this intervention for shoulder and neck pain; lateral epicondylitis; and myofascial pain. One Cochrane review (199) found that the evidence failed to confirm either a clinically important or a statistically significant benefit of BoNT-A injection for chronic neck pain associated with or without associated cervicogenic headache. Likewise, there was no benefit seen for disability and quality of life at four week and six months.

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Another Cochrane review (204) concluded that BoNT -A injections seem to reduce pain severity and improve shoulder function and range of motion when compared with placebo in patients with shoulder pain due to spastic hemiplegia or arthritis however the high risk of bias in the included RCTS demands caution in interpreting these results. Although Zhang (210) found that BoNT-A had a small to moderate analgesic effect in chronic musculoskeletal pain conditions, especially in plantar fasciitis, tennis elbow and back pain (but not in whiplash or shoulder pain), further evidence is required before definitive conclusions can be drawn. Kalichman (198) found that the evidence provided moderate support for use of BoNTA A injections into fore arm extensor muscles (60 units) for treatment of chronic treatment-resistant lateral epicondylitis. Finally, the review (196) which investigated BoNT-A for myofascial pain reported that current evidence does not support the use of BTA injection in trigger points for myofascial pain. Trigger point injections This intervention for musculoskeletal pain was reviewed in one review (202). In general, regardless of the drug, injected trigger point injection was no more effective than other less invasive treatments such as laser and ultrasound. Opiods. A recent and good quality Cochrane review (214) examined the effectiveness of any opioid taken by any route in any dose for at least six months in pain of any cause except cancer. Its findings suggested that opioids could be useful for those patients who have no previous history of addiction or abuse, however, the evidence supporting this conclusion is weak. More, longer term studies are required to identify those patients who would be likely to benefit from such treatment. Pulsed radiofrequency(PRF). Pulsed radiofrequency for Zygapophyseal joint pain, cervical radicular pain, lumbosacral pain, trigeminal neuralgia, chronic shoulder pain was investigated in one review [Chua 2011]. The review was of medium quality and found that PRF may be of benefit in treatment of cervical radicular pain and chronic shoulder pain, but less effective for lumbar zygapophyseal joint pain and trigeminal neuralgia but that further research is required to warrant its use. Spinal cord stimulation (SCS). Two reviews were identified which investigated SCS (193,203). Both were of medium to good quality. The most recent review found that SCS for Failed Back Surgery Syndrom and Complex

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Regional Pain Syndrome was effective when compared with conventional treatment. The other (203) had the same findings. However, for ischaemic pain, there may need to be selection criteria developed for Critical Limb Ischaemia, and SCS may have clinical benefit for refractory angina in the short term. Auriculotherapy. One good review (190) investigated auriculotherapy for all types of chronic pain. Although, overall it was found to be an effective intervention, the review concluded that further large, well-designed trials are required. Surgery. Five systematic reviews (176,197,200,207,215) and two NICE Interventional Procedures Guidelines (212,213) were identified. Summary of findings are presented in Appendix ??. A Cochrane review of medium /good quality (216) investigated discectomy, microdiscectomy, chemonucleolysis, automated percutaneous discectomy, nucleoplasty, and laser discectomy in patients with lumbar prolapsed disc who had indications for surgical intervention. It concluded that the evidence was weak and there was insufficient data to draw any conclusions about effectiveness of any of the surgical treatments investigated. Another good quality Cochrane review (197) looked at the effectiveness of spinal fusion for chronic low back pain. The results, which were based on three good quality RCTs showed that surgical fusion may improve pain related disability compared to nonsurgical intervention, but the effect was not statistically significant. A medium quality review, (176) looked at the effectiveness of surgery for low back pain. The included studies were assessed as low and high quality, but there were potential biases in some studies including performance bias, and detection bias. There were high drop-out rates in one trial and data were missing. Trials for decompressive surgery were assessed as high quality but a high proportion of patients did not adhere to the treatment. Overall, there was a lack of long-term studies, so the benefits were not known. A medium /good quality review which looked at total disc replacement surgery for back pain (207) found that there are no long-term studies to test the longevity of the prostheses which was evaluated. Therefore, current evidence does not support routine use of surgery for the treatment of chronic low back pain. Lumbar fusion for chronic back pain was investigated in one medium quality review (200). It appeared that the intervention may be more effective than non-operative care for chronic back pain but may not be more effective than structured rehabilitation, including CBT. However, methodological limitations of RCTs prevent firm conclusions about lumbar fusion. Lumbar fusion for chronic back pain was investigated in one medium quality review

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(200). It appeared that the intervention may be more effective than non-operative care for chronic back pain but may not be more effective than structured rehabilitation, including CBT. However, methodological limitations of RCTs prevent firm conclusions about lumbar fusion. Both of the Interventional Procedures Guidelines were based on good quality reviews of the research literature. IPG 300 addressed percutaneous endoscopic laser lumbar discectomy. The evidence consisted of case series. The guideline states: “ Current evidence on the safety and efficacy of percutaneous endoscopic laser lumbar discectomy is inadequate in quantity and quality. Therefore this procedure should only be used with special arrangements for clinical governance, consent, and audit or research”. IPG 357 addressed percutaneous intradiscal laser ablation in the lumbar spine. The evidence consisted of case series and non-randomised comparative studies. The guideline states: “Current evidence on the safety and efficacy of percutaneous intradiscal laser ablation in the lumbar spine is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit. Patients selected for the procedure should be limited to those with severe pain refractory to conservative treatment, in whom imaging studies have shown bulging of an intact disc, and who do not have neurological deficit requiring surgical decompression.”

8.12.1 Conclusions. There is little good evidence of effectiveness of sympathectomy, intrathecal drug therapy, nerve blocks, local analgesia, opioids, or auriculotherapy for chronic pain. A significant effect was observed for cervical epidural injections in relieving cervical neck pain. Facet joint injections are of little value in treating chronic low back pain. There is low to moderate support for the use of botulinum toxin injections for shoulder pain, neck pain, lateral epicondylitis and myofascial pain. Trigger point injections appear to be no more effective than other less invasive treatments. Further research is needed to warrant the use of pulsed radiofreqency for chronic pain. Spinal fusion may improve pain related disability but the effect was not significantly significant.

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Current evidence does not support the use of routine surgery for chronic back pain. There was insufficient good quality data to draw any conclusion about the effectiveness of many surgical interventions for low back pain. This included decompressive surgery, discectomy, micro-discectomy, chemonucleolysis, automated percutaneous discectomy, nucleoplasty and percutaneous endoscopic laser lumbardiscectomy. Percutaneous endoscopic laser lumbar discectomy should only be used with special arrangements for clinical governance, consent, and audit or research. Current evidence on the safety and efficacy of percutaneous laser ablation in the lumbar spine is adequate to support the use of this procedure provided normal arrangements are in place for clinical governance, consent and audit.

8.12.2 Implications for practice. SCS should be commissioned for use for those patients who fail to respond to other treatments. Spinal fusion can only be recommended cautiously to patients with chronic low back pain. Botulinum toxin should not be commissioned for chronic pain. Surgery should only be commissioned for treatment in highly selected patients who fail all other treatments and with caution. Patients should be made aware of implications of surgery. Surgical discectomy should not be commissioned for routine use, but only in carefully selected patients with sciatica due to lumbar disc prolapsed. Current evidence on the safety and efficacy of percutaneous laser ablation in the lumbar spine is adequate to support the use of this procedure provided normal arrangements are in place for clinical governance, consent and audit.

MULTI-DISCIPLINARY INTERVENTIONS (MDI) 8.13 Two good quality systematic reviews (217,218) a NICE guideline and guideline from the American Pain Society / American College of Physicians (157) investigated MDI programmes. The reviews identified used different definitions of MDI, therefore, they are not directly comparable.

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The results of one Cochrane review(218) found that one high quality study showed effectiveness for low intensive multidisciplinary treatment compared to control, but not for intensive multidisciplinary treatment for chronic low back pain. The other (low quality) studies found no effectiveness compared to controls. Three high quality RCTs found effectiveness for some outcome measures (but not all) for intensive compared to non-intensive programmes. It concluded that multidisciplinary back training has a positive impact on work participation of people with chronic low back pain. The evidence for a positive effect on quality of life is limited. Intensity of treatment is not associated with treatment effectiveness. It concluded that further research should be carried out with clearer definitions of chronic low back pain, intensity of treatment and multidisciplinary back training. The second review investigated multi-disciplinary pain interventions for adults with chronic non-specific musculoskeletal pain for example low back pain or back pain and fibromyalgia. Results showed that evidence was strong for MDI being more effective than control group treatment in 15 studies, five studies showed no difference. Three studies that compared in-patient versus out-patient treatment found moderate evidence for better long term outcomes with intensive in-patient MDI. All interventions considered in the NICE guideline (156), which was under-pinned by a good quality systematic review, had to have a psychological component such as CBT, counselling or coping skills training. Studies were included if the content was broadly similar to that recommended in the British Pain Society guidelines (BPS 2007) as follows: â&#x20AC;&#x153;education on pain physiology, pain psychology, healthy function and self-management of pain problems; and of guided practice on setting goals and working towards them, identifying and changing unhelpful beliefs and ways of thinking, relaxation, and changing habits which contribute to disability. Participants practise these skills in their home and other environments to become expert in their application and integration. â&#x20AC;&#x153;PMPs are delivered in a group format to normalise pain experience, to maximise possibilities of learning from other group members, and for economy.â&#x20AC;? The guideline recommends to consider referral for a combined physical and psychological treatment programme, comprising around 100 hours over a maximum of eight weeks, for people who have received at least one less intensive treatment and have high disability and/or significant psychological distress. Combined physical and psychological treatment programmes should include a cognitive behavioural approach and exercise. The APS/ACP guidelines (157) findings were as follows: Intensive (>100 hours), daily interdisciplinary rehabilitation was moderately superior to noninterdisciplinary rehabilitation or usual care for short-and long-term functional status, and for pain outcomes (at three to four months in two trials). Long-term pain and return to work outcomes were inconsistent;

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Less intensive interdisciplinary rehabilitation was no better than non-interdisciplinary rehabilitation or usual care; Functional restoration with a CBT component was more effective than usual care, normal activities or standard exercise therapy for reducing time lost from work. There was little evidence that functional restoration without a CBT component is effective; In conclusion, interdisciplinary rehabilitation was more effective than usual care for subacute back pain.

8.13.1 Conclusions. There is considerable heterogeneity between reviews and between the included RCTs. Effectiveness of the intervention is likely to vary depending on the comparator, in particular whether it is an active comparator (which may incorporate some of the elements or similar elements of the multidisciplinary intervention), or a wait list control. Comparisons across studies (and across reviews) are therefore difficult due to variability in the definition of multidisciplinary treatment (type and number of elements), the comparators, the outcome measures/instruments used and follow-up times (e.g. short-term, intermediate or long-term). The â&#x20AC;&#x2DC;treatment as usualâ&#x20AC;&#x2122; often used as the comparator is likely to vary between studies. Due to the heterogeneity, there are often few studies that make a direct head-to-head comparison between particular combinations of treatments. Overall, there seems be some moderately strong evidence, based on RCTs of variable quality, that multidisciplinary programmes/more intensive programmes are significantly better than usual care/less intensive programmes for some outcomes relating to pain and function. This was the case mainly for shorter-term outcomes, with less evidence for longer-term outcomes. No evidence was identified for residential programmes specifically. Several reviews highlight that it is not known which treatment components are most effective and which patients would benefit most.

8.13.2 Implications for practice. Bearing in mind the caveats above, multi-disciplinary pain management programmes should be commissioned.

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APPENDIX I â&#x20AC;&#x201C; ADMITTED PATIENT COMMISSIONING DATA SET (CDS) DATA REQUEST SPECIFICATIONS Request 1: Admitted patient episodes by Provider Trust, admission method, patient classification, gender and financial year Dataset Setting: Source dataset: Unit: Inclusion criteria: Coverage: Ages: Gender: Time period: Other: Output table Statistic column: Row variables: Column variable:

Provider Trust Code

Admitted Patient episodes Admitted Patient Care - General Episode Commissioning Data Set Finished Consultant Episodes (FCEs) Patients admitted to a West Midlands provider 16 years and over Persons Financial years: 2007/8, 2008/9, 2009/10, 2010/11, 2011/12 Where primary procedure is in the attached OPCS4 Code list (Appendix II)

Count of FCEs Financial year, Provider Trust, admission method, patient classification, gender n/a

Provider Trust Name

Gender

Admission Patient Method Classification

Count of FCEs

Request 2: Admitted patient episodes by Provider Trust, primary procedure, gender and financial year Dataset Setting: Source dataset: Unit: Inclusion criteria: Coverage: Ages: Gender: Time period:

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Other:

Where primary procedure is in the attached OPCS4 Code list (Appendix II)

Output table Statistic column: Row variables: Column variable:

Provider Trust Code

Count of FCEs Financial year, Provider Trust, primary procedure, gender n/a

Provider Trust Name

Gender

Primary procedure OPCS4 Code (4-digit)

Count of FCEs

Request 3: Admitted patient episodes by Primary Care Trust, admission method, patient classification, gender and financial year Dataset Setting: Source dataset: Unit: Inclusion criteria: Coverage: Ages: Gender: Time period: Other:

Admitted Patient episodes Admitted Patient Care - General Episode Commissioning Data Set Finished Consultant Episodes (FCEs) Patients resident in West Midlands Primary Care Trusts 16 years and over Persons Financial years: 2007/8, 2008/9, 2009/10, 2010/11, 2011/12 Where primary procedure is in the attached OPCS4 Code list (Appendix II)

Output table Statistic column: Row variables: Column variable:

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ONS Area Code

PCT Code

Count of FCEs Financial year, Primary Care Trust, admission method, patient classification, gender n/a

PCT Name

Gender

Admission Patient Method Classification

Count of FCEs

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Request 4: Admitted patient episodes by Primary Care Trust, primary procedure, gender and financial year Dataset Setting: Source dataset: Unit: Inclusion criteria: Coverage: Ages: Gender: Time period: Other: Output table Statistic column: Row variables: Column variable:

Provider Trust Code

Count of FCEs Financial year, Primary Care Trust, primary procedure, gender n/a

Provider Trust Name

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Gender

Primary procedure OPCS4 Code (4-digit)

Count of FCEs

113

APPENDIX II â&#x20AC;&#x201C; PAIN MANAGEMENT PROCEDURE CODES OPCS4 Code A48.3 A48.4 A48.5 A48.6 A48.7 A48.8 A09.1 A09.2 A09.3 A09.4 A09.5 A09.8 A09.9 A70.1 A70.2 A70.3 A70.4 A70.5 A70.6 A70.7 A70.8 A70.9 A48.3 A48.4 A48.5 A48.6 A48.7 A48.8 A52.1 A52.2 A52.3 A52.8 A52.9 A54.1 A54.2 A54.3 A54.4 A54.5 A54.8 A54.9 A57.1

Procedure Insertion of neurostimulator adjacent to spinal cord Attention to neurostimulator adjacent to spinal cord NEC Reprogramming of neurostimulator adjacent to spinal cord Removal of neurostimulator adjacent to spinal cord Insertion of neurostimulator electrodes into the spinal cord Other specified other operations on spinal cord Implantation of neurostimulator into brain Maintenance of neurostimulator in brain Removal of neurostimulator from brain Operation on neurostimulator in brain NEC Insertion of neurostimulator electrodes into the brain Other specified neurostimulation of brain Unspecified neurostimulation of brain Implantation of neurostimulator into peripheral nerve Maintenance of neurostimulator in peripheral nerve Removal of neurostimulator from peripheral nerve Insertion of neurostimulator electrodes into peripheral nerve Electroacupuncture Acupuncture NEC Application of transcutaneous electrical nerve stimulator Other specified neurostimulation of peripheral nerve Unspecified neurostimulation of peripheral nerve Insertion of neurostimulator adjacent to spinal cord Attention to neurostimulator adjacent to spinal cord NEC Reprogramming of neurostimulator adjacent to spinal cord Removal of neurostimulator adjacent to spinal cord Insertion of neurostimulator electrodes into the spinal cord Other specified other operations on spinal cord Therapeutic lumbar epidural injection Therapeutic sacral epidural injection Epidural blood patch Other specified therapeutic epidural injection Unspecified therapeutic epidural injection Injection of destructive substance into cerebrospinal fluid Injection of therapeutic substance into cerebrospinal fluid Implantation of intrathecal drug delivery device adjacent to spinal cord Attention to intrathecal drug delivery device adjacent to spinal cord Removal of intrathecal drug delivery device adjacent to spinal cord Other specified therapeutic spinal puncture Unspecified therapeutic spinal puncture Extirpation of lesion of spinal nerve root

Chronic pain health needs assessment 114

OPCS4 Code A57.2 A57.3 A57.4 A57.5 A57.6 A57.7 A57.8 A57.9 V29.1 V29.2 V29.3 V29.4 V29.5 V29.6 V29.8 V29.9 V33.1 V33.2 V33.3 V33.4 V33.5 V33.6 V33.7 V33.8 V33.9 V34.1 V34.2 V34.3 V34.4 V34.5 V34.6 V34.7 V34.8 V34.9 V35.1 V35.2 V35.8

Procedure Rhizotomy of spinal nerve root Radiofrequency controlled thermal destruction of spinal nerve root Injection of destructive substance into spinal nerve root Destruction of spinal nerve root NEC Reimplantation of spinal nerves into spinal cord Injection of therapeutic substance around spinal nerve root Other specified operations on spinal nerve root Unspecified operations on spinal nerve root Primary laminectomy excision of cervical intervertebral disc Primary hemilaminectomy excision of cervical intervertebral disc Primary fenestration excision of cervical intervertebral disc Primary anterior excision of cervical intervertebral disc and interbody fusion of joint of cervical spine Primary anterior excision of cervical intervertebral disc NEC Primary microdiscectomy of cervical intervertebral disc Other specified primary excision of cervical intervertebral disc Unspecified primary excision of cervical intervertebral disc Primary laminectomy excision of lumbar intervertebral disc Primary fenestration excision of lumbar intervertebral disc Primary anterior excision of lumbar intervertebral disc and interbody fusion of joint of lumbar spine Primary anterior excision of lumbar intervertebral disc NEC Primary anterior excision of lumbar intervertebral disc and posterior graft fusion of joint of lumbar spine Primary anterior excision of lumbar intervertebral disc and posterior instrumentation of lumbar spine Primary microdiscectomy of lumbar intervertebral disc Other specified primary excision of lumbar intervertebral disc Unspecified primary excision of lumbar intervertebral disc Revisional laminectomy excision of lumbar intervertebral disc Revisional fenestration excision of lumbar intervertebral disc Revisional anterior excision of lumbar intervertebral disc and interbody fusion of joint of lumbar spine Revisional anterior excision of lumbar intervertebral disc NEC Revisional anterior excision of lumbar intervertebral disc and posterior graft fusion of joint of lumbar spine Revisional anterior excision of lumbar intervertebral disc and posterior instrumentation of lumbar spine Revisional microdiscectomy of lumbar intervertebral disc Other specified revisional excision of lumbar intervertebral disc Unspecified revisional excision of lumbar intervertebral disc Primary excision of intervertebral disc NEC Revisional excision of intervertebral disc NEC Other specified excision of unspecified intervertebral disc

Chronic Pain Health Needs Assessment

115

OPCS4 Code V35.9 V25.1 V25.2 V25.3 V25.4 V25.5 V25.6 V25.7 V25.8 V25.9 V26.1 V26.2 V26.3 V26.4 V26.5 V26.6 V26.7 V26.8 V26.9 V38.1 V38.2 V38.3 V38.4 V38.5 V38.6 V38.8 V38.9 V48.1 V48.2 V48.3 V48.4 V48.5 V48.6 V48.7 V48.8 V48.9 V52.1 V52.2 V52.3 V52.4

116

Procedure Unspecified excision of unspecified intervertebral disc Primary extended decompression of lumbar spinal cord and intertransverse fusion of joint of lumbar spine Primary extended decompression of lumbar spinal cord NEC Primary posterior decompression of lumbar spinal cord and intertransverse fusion of joint of lumbar spine Primary posterior laminectomy decompression of lumbar spinal cord Primary posterior decompression of lumbar spinal cord NEC Primary lateral foraminotomy of lumbar spine Primary anterior corpectomy of lumbar spine and reconstruction HFQ Other specified primary decompression operations on lumbar spine Unspecified primary decompression operations on lumbar spine Revisional extended decompression of lumbar spinal cord and intertransverse fusion of joint of lumbar spine Revisional extended decompression of lumbar spinal cord NEC Revisional posterior decompression of lumbar spinal cord and intertransverse fusion of joint of lumbar spine Revisional posterior laminectomy decompression of lumbar spinal cord Revisional posterior decompression of lumbar spinal cord NEC Revisional lateral foraminotomy of lumbar spine Revisional anterior corpectomy of lumbar spine and reconstruction HFQ Other specified revisional decompression operations on lumbar spine Unspecified revisional decompression operations on lumbar spine Primary fusion of joint of thoracic spine Primary posterior interlaminar fusion of joint of lumbar spine Primary posterior fusion of joint of lumbar spine NEC Primary intertransverse fusion of joint of lumbar spine NEC Primary posterior interbody fusion of joint of lumbar spine Primary transforaminal interbody fusion of joint of lumbar spine Other specified primary fusion of other joint of spine Unspecified primary fusion of other joint of spine Radiofrequency controlled thermal denervation of spinal facet joint of cervical vertebra Denervation of spinal facet joint of cervical vertebra NEC Radiofrequency controlled thermal denervation of spinal facet joint of thoracic vertebra Denervation of spinal facet joint of thoracic vertebra NEC Radiofrequency controlled thermal denervation of spinal facet joint of lumbar vertebra Denervation of spinal facet joint of lumbar vertebra NEC Radiofrequency controlled thermal denervation of spinal facet joint of vertebra NEC Other specified denervation of spinal facet joint of vertebra Unspecified denervation of spinal facet joint of vertebra Enzyme destruction of intervertebral disc Destruction of intervertebral disc NEC Discography of intervertebral disc Biopsy of lesion of intervertebral disc NEC

Chronic Pain Health Needs Assessment

OPCS4 Code V52.5 V52.8 V52.9 V54.4 W90.1 W90.2 W90.3 W90.4 W90.8 W90.9

Procedure Aspiration of intervertebral disc NEC Other specified other operations on intervertebral disc Unspecified other operations on intervertebral disc Injection around spinal facet of spine Aspiration of joint Arthrography Injection of therapeutic substance into joint Injection into joint NEC Other specified puncture of joint Unspecified puncture of joint

Chronic Pain Health Needs Assessment

117

APPENDIX NN Key recommendations of the NICE CG 88 and the American College of Physicians / American Pain Society Guidelines on low back pain. National Institute for Health and Clinical Excellence. Low back pain. Early management of persistent non-specific low back pain. CG 88; 2009. Key recommendations: Information, education and patient preferences:  

Provide people with advice and information to promote self-management of their low back pain. Offer one of the following treatment options, taking into account patient preference: an exercise programme, a course of manual therapy or a course of acupuncture. Consider offering another of these options if the chosen treatment does not result in satisfactory improvement

Physical activity and exercise   

Consider offering a structured exercise programme tailored to the person: this should comprise up to a maximum of eight sessions over a period of up to 12 weeks. Offer a group supervised exercise programme, in a group of up to 10 people. A one-to-one supervised exercise programme may be offered if a group programme is not suitable for a particular person.

Manual therapy 

Consider offering a course of manual therapy, including spinal manipulation, comprising up to a maximum of nine sessions over a period of up to 12 weeks

Invasive procedures  

Consider offering a course of acupuncture needling comprising up to a maximum of 10 sessions over a period of up to 12 weeks. Do not offer injections of therapeutic substances into the back for non-specific low back pain.

Combined physical and psychological treatment programme Consider referral for a combined physical and psychological treatment programme, comprising around 100 hours over a maximum of 8 weeks, for people who: − have received at least one less intensive treatment and − have high disability and/or significant psychological distress Assessment and imaging  

Do not offer X-ray of the lumbar spine for the management of non-specific low back pain. Only offer an MRI scan for non-specific low back pain within the context of a referral for an opinion on spinal fusion.

Chronic pain health needs assessment 118

Referral for surgery Consider referral for an opinion on spinal fusion for people who: â&#x2C6;&#x2019; have completed an optimal package of care, including a combined physical and psychological treatment programme (section 1.7) and â&#x2C6;&#x2019; still have severe non-specific low back pain for which they would consider surgery.

Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Int Med 2007; 147 (7): 478-91. Key recommendations: Recommendation 1: Clinicians should conduct a focused history and physical examination to help place patients with low back pain into 1 of 3 broad categories: nonspecific low back pain, back pain potentially associated with radiculopathy or spinal stenosis, or back pain potentially associated with another specific spinal cause. The history should include assessment of psychosocial risk factors, which predict risk for chronic disabling back pain (strong recommendation, moderate-quality evidence). Recommendation 2: Clinicians should not routinely obtain imaging or other diagnostic tests in patients with nonspecific low back pain (strong recommendation, moderate-quality evidence). Recommendation 3: Clinicians should perform diagnostic imaging and testing for patients with low back pain when severe or progressive neurologic deficits are present or when serious underlying conditions are suspected on the basis of history and physical examination (strong recommendation, moderate-quality evidence). Recommendation 4: Clinicians should evaluate patients with persistent low back pain and signs or symptoms of radiculopathy or spinal stenosis with magnetic resonance imaging (preferred) or computed tomography only if they are potential candidates for surgery or epidural steroid injection (for suspected radiculopathy) (strong recommendation, moderate-quality evidence). Recommendation 5: Clinicians should provide patients with evidence- based information on low back pain with regard to their expected course, advise patients to remain active, and provide information about effective self-care options (strong recommendation, moderate-quality evidence). Recommendation 6: For patients with low back pain, clinicians should consider the use of medications with proven benefits in conjunction with back care information and self-care. Clinicians should assess severity of baseline pain and functional deficits, potential benefits, risks, and relative lack of long-term efficacy and safety data before initiating therapy (strong recommendation, moderate-quality evidence). For most patients, first-line medication options are acetaminophen or non-steroidal anti-inflammatory drugs. Recommendation 7: For patients who do not improve with self-care options, clinicians should consider the addition of non-pharmacologic therapy with proven benefits-for acute low back pain, spinal manipulation; for chronic or sub-acute low back pain, intensive interdisciplinary rehabilitation, exercise therapy, acupuncture, massage therapy, spinal manipulation, yoga, cognitive-behavioural therapy, or progressive relaxation (weak recommendation, moderate-quality evidence).

Chronic Pain Health Needs Assessment

119

APPENDIX NN Search strategies for evidence of effectiveness of interventions in chronic pain Database Cochrane Library 2011 Issue 4

1. 2. 3. 4. 5.

ARIF (Aggressive Research Intelligence Facility) MEDLINE (OVID MEDLINE (R) 1948 to November week 3 2011

EMBASE 1974 to 2011 week 48

TRIP database PROSPERO (International prospective register of systematic reviews that are ongoing)

120

Search strategy “chronic pain” MeSH descriptor Pain explode all trees MeSH descriptor Chronic Disease explode all trees (2 AND 3) (1 OR 4)

Chronic pain (selected abstracts) 1. Chronic pain.ab, ti. 2. Pain.sh. 3. Chronic disease.sh. 4. 2 AND 3 5. 1 OR 4 6. Limit 5 to “reviews (maximises specificity)” 1. Chronic pain. ti, ab. 2. Exp pain/ 3. Exp chronic disease/ 4. 2 AND 3 5. 1 OR 4 6. Limit 5 to “reviews (maximises specificity)” 1. “Chronic pain” Chronic pain Pain

Chronic Pain Health Needs Assessment

Search strategies to identify evidence of effectiveness for chronic back pain Database Cochrane library 2012 Issue 2

Search strategy #1 ("low back pain") OR ("back pain") #2 "chronic" #3 (#1 AND #2) #4 ("cognitive behavioural therapy") OR ("cognitive behaviour therapy") OR ("cognitive therapy") OR ("behaviour therapy") OR ("behavioural therapy") OR ("CBT") #5 (#3 AND #4) #6 ("discectomy") OR ("lumbar discectomy") #7 (#3 AND #6) #8 ("microdiscectomy") OR ("microdecompression") OR ("lumbar microdecompression") #9 (#3 AND #8) #10 ("facet joint injection") #11 (#3 AND #10) #12 ("pain management programme") OR ("pain management programmes") #13 (#3 AND #12)

MEDLINE (OVID MEDLINE (R) 1948 to May 2012)

1. back pain.tw. 2. Back Pain/ 3. low back pain.tw. 4. Low Back Pain/ 5. chronic low back pain.tw. 6. dorsalgia.tw. 7. 1 or 2 or 3 or 4 or 5 or 6 8. microdiscectomy.tw. 9. microdecompression.tw. 10. Decompression, Surgical/ 11. 8 or 9 or 10 12. facet joint injection.tw. 13. pain management program*.tw. 14. Pain Management/ 15. 13 or 14 16. discectomy.tw. 17. Diskectomy/ 18. diskectomy.tw. 19. 16 or 17 or 18 20. cognitive behavioural therapy.tw. 21. Cognitive Therapy/ 22. behaviour therapy.tw.

Chronic Pain Health Needs Assessment

23. cognitive psychotherap*.tw. 24. cbt.tw. 25. 20 or 21 or 22 or 23 or 24 26. 7 and 11 27. 7 and 12 28. 7 and 15 29. 7 and 19 30. 7 and 25

121

EMBASE (1974 to May 2012)

122

1. back pain.tw. 2. backache/ 3. backache.tw. 4. low back pain.tw. 5. low back pain/ 6. chronic low back pain.tw. 7. dorsalgia.tw. 8. 1 or 2 or 3 or 4 or 5 or 6 or 7 9. microdiscectomy.tw. 10. intervertebral diskectomy/ 11. intervertebral diskectomy.tw. 12. microdecompression.tw. 13. decompression surgery/ 14. 9 or 10 or 11 or 12 or 13 15. facet joint injection.tw. 16. methylprednisolone acetate/ or corticosteroid/ or bupivacaine/ or methylprednisolone/ or lidocaine/ or local anesthetic agent/ or betamethasone/ 17. 15 or 16 18. pain management program*.tw. 19. discectomy.tw. 20. 10 or 11 or 19 27. cbt.tw. 28. 21 or 22 or 23 or 24 or 25 or 26 or 27

21. cognitive behavioural therap*.tw. 22. cognitive therapy/ 23. behaviour therapy.tw. 24. behavior therapy/ 25. cognitive psychotherap*.tw. 26. psychological aspect/ 29. 8 and 17 30. 8 and 18 31. 8 and 20 32. 8 and 14 33. 8 and 28

Chronic Pain Health Needs Assessment

Appendix 1

Link to main document Summary of findings: Manual therapy (manipulation and mobilisation)

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

Gross (2010) (219) Manipulation or mobilisation for neck pain

27 RCTs (1522 participants)

With metaanalysis

Neck pain without radicular findings, including neck pain without specific cause, whiplash associated disorder, myofascial pain syndrome, neck disorders associated with degenerative diseases

Chronic pain health needs assessment

Manipulation or mobilisation

Placebo (sham/mock mobilisation or other sham treatment), adjunct treatment, wait list or no treatment, another treatment (manipulation or mobilisation versus another treatment, one technique of manipulation or

Pain relief, disability, function, patient satisfaction, global perceived effect, QoL

Cervical manipulation for sub-acute/chronic neck pain: moderate quality evidence suggested manipulation and mobilisation produced similar effects on pain, function and patient satisfaction at intermediate-termfollow-up. Low quality evidence that manipulation alone compared to a control may provide short term relief following one to four sessions (SMD pooled=-0.90; 95%CI:-1.78, -0.02). Thoracic manipulation

123

Cervical manipulation and mobilisation produced similar changes

Optimal techniques and

Comments

Level 1

As a Cochrane review, this is an authoritative summary of the present state of evidence. While the estimated effects look impressive the quality of evidence is poor. Hence these treatments should be available for those

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability Cochrane review PRISMA:2 items missing AMSTAR: Good

Either may provide immediate or short-term change; no longterm data are available. Thoracic manipulation may improve pain and function

OCEBM level

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

mobilisation versus another, one dose of manipulation or mobilisation versus another dose

for acute/chronic neck pain: Low quality evidence supported thoracic manipulation as an additional therapy for pain reduction (NNT 7; 46.6% treatment advantage) and increased function (NNT 5; 40.6% treatment advantage) in acute pain and favoured single session of thoracic manipulation for immediate pain reduction compared to placebo for chronic neck pain (NNT 5; 29% treatment advantage). Mobilisation for subacute/chronic neck pain: in addition to the evidence noted above, low quality evidence for sub-acute and chronic neck pain

124

Chronic Pain Health Needs Assessment

dose are unresolved Further research is very likely to have an important impact on the estimate of effect and is likely to change the estimate

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability patients who choose to have it

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

indicated that 1) Combination of Maitland mobilisation techniques was similar to acupuncture for immediate pain relief and increased function; 2) There was no difference between mobilisation and acupuncture as additional treatments for immediate pain relief and improved function; 3) Neural dynamic mobilisations may produce clinically important reduction of pain immediately posttreatment. Certain mobilisations were superior Side effects: 3 of 8 studies that looked at side effects reported

Chronic Pain Health Needs Assessment

125

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

OCEBM level

Comments

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

Miller (2010) (159) Manual therapy and exercise for neck pain: a systematic review

17 RCTs

With metaanalysis

Neck pain with or without radicular symptoms or cervicogenic headache

Manual therapy including manipulation or mobilisation techniques, combined with exercise

Placebo, wait list/no treatment group, an adjunct treatment (e.g., mobilisation and exercise plus ultrasound versus ultrasound), or another treatment

Pain function/disability, QOL, global perceived effect, patient satisfaction for short-term ((closest to 4 weeks) to longterm (closest to 12 weeks) follow-up

none. The other 5 reported only minor and temporary effects Of 17 RCTs included, 29% had a low risk of bias. Low quality evidence suggests clinically important long-term improvements in pain (SMD= -0.50 (95%CI:0.76, -0.24) than exercise alone, but no long-term differences across multiple outcomes for (sub) acute/chronic neck pain with or without cervicogenic headache.

Moderate quality evidence supports this treatment combination for pain reduction and improved quality of life over manual therapy alone for chronic neck pain. Evidence suggests that there is greater short-term pain reduction when compared to traditional care for acute whiplash Evidence regarding radiculopathy was sparse

126

Chronic Pain Health Needs Assessment

OCEBM level

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

Not Cochrane review PRISMA:5 items missing AMSTAR: Good

Level 1

Comments

Appendix 2

Link to main document Summary of findings: Pharmacological procedures

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

Siedel (2010) (160) Antipsychotics for acute and chronic pain in adults

11 studies, randomised controlled trials (770 participants)

Without metaanalysis

Chronic Pain Health Needs Assessment

Patients of either gender, with acute or chronic pain

Any form of antipsychotic treatment (at any dose)

No treatment, placebo, or other painrelieving treatments (e.g., nonsteroidal, antiinflammatory drugs, antidepressants, anticonvulsan ts, opioids)

Reduction in pain intensity, as measured by the visual analogue scale, selfreported pain relief

Adverse effects, attrition, measures of satisfaction or patient preference, assessment of quality of life

Of 11 RCTs, 5 studies showed beneficial effects of antipsychotics in treatment of acute and chronic pain Results regarding treatment of neuropathic pain were contradictory; there was no significant effect for post herpetic neuralgia with fluphenazine, but there was significant pain reduction in trigeminal neuralgia

127

Positive effects on painful conditions in 6 trials, whereas 5 trials failed to report any analgesic effect.

OCEBM level

Comments

Level 1

Data was limited, most trials only studied small patient samples. Further research is required

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability Not Cochrane review PRISMA:8 items missing AMSTAR:Good/ medium

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

OCEBM level

Comments

Level 1

Internal and external validity of RCTs was limited, short duration, long-term treatment evidence is lacking. Lack of information on whether antidepressa nt reduce fibromyalgia

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

with pimozide treatment Most frequently reported adverse effects were involuntary movements, parkinsonism, akathisia and sedating effects Hauser (2009) (161) Treatment of fibromyalgia syndrome with antidepressants

128

18 randomised controlled trials (1427 participants)

With metaanalysis

Fibromyalgia

Tricyclic and tetracyclic antidepressants [TCAs], selective serotonin reuptake inhibitors [SSRIs], serotonin and noradrenaline reuptake inhibitors [SNRIs], or monoamine oxidase

Pharmacologi cal placebo

Pain, fatigue, sleep, and depressed mood

Healthrelated quality of life

Strong evidence for association of antidepressants with pain reduction (SMD -0.43; 95%CI: 0.55, -0.30), fatigue (SMD: -0.13; 95%CI:0.26, -0.01), depressed mood (SMD: -0.26; 95%CI:0.39, -0.12), sleep disturbances (SMD: -0.32; 95%CI: -0.46, -0.18) Strong evidence for

Chronic Pain Health Needs Assessment

Short-term usage of amytriptyline and duloxetine can be considered for treatment of pain and sleep disturbances in fibromyalgia.

Not Cochrane review PRISMA:2 items missing AMSTAR:Good

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

inhibitors [MAOIs]

Saarto (2010) (162) Antidepressants for neuropathic pain

61 randomised controlled trials, included 3293 participants

Chronic Pain Health Needs Assessment

Adult male and female patients with any neuropathic pain

TCAs, MAOIs, SSRIs, SNRIs, RIMAs, newer antidepressant (nefazodone,mi rtazepine, venlafaxine), other

OCEBM level

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

association of antidepressants with improved health-related QOL (SMD: -0.31; 95%CI: -0.42, -0.20)

Placebo, active control drug, another antidepressa nt, any other intervention

Patient reported global improveme nt or pain relief or both, measured

Quality of life, adverse effects, sleep parameters, depression measures

Effect sizes for pain reduction were large for TCAs (SMD: -1.64; 95%CI: -2.47, -0.71), medium for MAOIs (SMD: -0.54; 95%CI: -1.02, -0.07) and small for SSRIs (SMD: -0.36; 95%CI: -0.77, -0.01) and SNRIs (SMD: -0.36; 95%CI: -0.46, -0.25) TCAs are effective and have an NNT of 3.6 (95% CI 3 to 4.5) RR 2.1 (95% CI 1.8 to 2.5) for the achievement of at least moderate pain relief

129

Comments

related costs

There is some, limited evidence for the role of SSRIs Both TCAs and venlafaxine have NNTs of

Cochrane review PRISMA:4 items missing AMSTAR: Good

Level 1

The use of antidepressa nt (TCAs and SSRIs) should be included as part of the pain service

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

(bupropion, etoperidone, flupenthixol, fluphenazine, hypericum (St John’sWort), mirtazepine, nefazodone, reboxetine, tianeptine, and tryptophan

on any scale

Limited evidence for the effectiveness of the newer SSRIs but no studies of SNRIs were found Insufficient data to assess effectiveness for other antidepressants such as St John’s Wort and Ltryptophan. For diabetic neuropathy the NNT for effectiveness was 1.3 (95% CI 1.2 to 1.5) RR 12.4 (95% CI 5.2 to 29.2) (five studies); for post herpetic neuralgia 2.7 (95% CI 2 to 4.1), RR 2.2 (95% CI 1.6 to 3.1) (four studies) evidence that TCAs

130

Chronic Pain Health Needs Assessment

approximately 3 for moderate pain relief. There is evidence to suggest that other antidepressants may be effective but numbers of participants are insufficient to calculate robust NNTs. SSRIs are generally better tolerated by patients but more high quality studies are required

PRISMA – items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

OCEBM level

Comments

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

OCEBM level

Comments

Level 1

Duloxetine is effective and should be part of the pain service

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

are not effective in HIV-related neuropathies. The number needed to harm (NNH) for major adverse effects defined as an event leading to withdrawal from a study was 28 (95% CI 17.6 to 68.9) for amitriptyline and 16.2 (95% CI 8 to 436) for venlafaxine

Lunn (2011) (163) Duloxetine for treatming painful

6 randomised or quasirandomised controlled trials, 2220

With metaanalysis

Chronic Pain Health Needs Assessment

Any form of painful peripheral neuropathy or chronic

All formulations and doses of duloxetine

Placebo or other controls

Improveme nt of pain (up to 12 weeks) using

Long-term (more than 12 weeks) improvement of pain,

The NNH for minor adverse effects was 6 (95% CI 4.2 to 10.7) for amitriptyline and 9.6 (95% CI 3.5 to 13) for venlafaxine Duloxetine at 60 mg daily is effective in treating painful diabetic peripheral neuropathy in the

131

Moderately strong evidence that duloxetine 60 mg and 120 mg daily is

Cochrane review PRISMA: no items missing

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

neuropathy or chronic pain

participants

pain

validated scales of pain intensity or pain relief

improvement in short-term and long term pain of at least 30%, improvement in any validated QOL score of more than 30%

short-term to 12 weeks with a risk ratio (RR) for 50% pain reduction at 12 weeks of 1.65 (95% confidence interval (CI) 1.34 to 2.03); NNT 6 (95%CI: 5 to 10) Duloxetine at 60 mg daily is also effective in fibromyalgia over 12 weeks (RR for 50% reduction in pain 1.57, 95%CI 1.20 to 2.06; NNT 8, 95%CI: 5 to 17) and 28 weeks (RR 1.58, 95%CI: 1.10 to 2.27) Adverse events were common in both treatment and placebo arms but more common in the treatment arm with a dose

132

Chronic Pain Health Needs Assessment

efficacious for treating pain in diabetic peripheral neuropathy and fibromyalgia Minor side effects are common at therapeutic doses but serious side effects are rare. Direct comparisons needed of duloxetine with other antidepressants and with other drugs already shown to be efficacious in neuropathic pain with

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

AMSTAR:Good

that is commissione d

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

Matthews (2009) (164) Topical rubefacients for acute and chronic pain in adults

7 randomised controlled trials included

With metaanalysis

Chronic Pain Health Needs Assessment

Acute and chronic pain

Topical rubefacients containing salicylates or nicotinamides

Topical placebo

“clinical success”, defined as a 50% reduction in pain, or equivalent measure such as a “very good” or “excellent” global assessment of treatment, or “none” or “slight”

numbers of participants with adverse events: local and systemic, and cough numbers of withdrawals: all cause, lack of efficacy, adverse events

dependent effect. Most side effects were minor, but 16% of participants stopped the drug due to side effects. Serious adverse events were rare

unbiased economic analyse

In chronic pain the NNT for effective pain relief was 6.2 (95% CI: 4.0 to 13) when compared to topical placebo). There were insufficient data to draw conclusions against active controls

The evidence was limited by the quality and size of the available studies. The evidence of effectiveness was more robust in chronic pain with rubefacients providing effective relief to 1 in 6 patients who use them over

133

OCEBM level

PRISMA – items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

Cochrane review PRISMA:1 item missing AMSTAR:Good

Level 1

Comments

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

pain on rest or movement measured on a categorical scale patientreported reduction in pain of at least 50% patientreported global assessment of treatment; pain on movement pain on rest, or spontaneo us pain

134

Chronic Pain Health Needs Assessment

and above background improvement with a placebo

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

OCEBM level

Comments

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

Papaleontiou (2010) (165) Outcomes associated with opioid use in the treatment of chronic noncancer pain in older adults: a systematic review and meta-analysis

31 RCTs, 8 open-label observational studies, one retrospective cohort study

With metaanalysis

8690 participants

Chronic noncancer pain in older adults

Tramadol, opioids

Placebo, or add on to existing therapy, or another active treatment

undefined “improvem ent” Pain intensity, physical quality of life, mental quality of life, sleep

Weighted mean subject age was 64.1 years (mean age range:60-73) Mean duration of treatment studies was 4 weeks and only 5 studies lasted longer than 12 weeks. In meta-analysis, effect size for pain reduction was 0.557 (P<0.001), 0.432 (P<0.001) for physical disability reduction, and 0.859 (P=0.309) for improved sleep Common adverse

Chronic Pain Health Needs Assessment

135

Among older adults with chronic pain, there was no significant comorbidity, and short term use of opioids was associated with reductions in pain intensity, improved physical functioning but decreased mental health functioning

OCEBM level

Comments

Level 1 (majority of studies were RCTs)

Limitations in the available evidence require further research, however, use of opioids for short-term treatment is reasonable for older patients without comorbidity and either nociceptive or neuropathic pain with frequent surveillance for adverse

PRISMA – items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

Not Cochrane review PRISMA: 4 items missing AMSTAR:Good/ medium

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

OCEBM level

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

effects included constipation, nausea, dizziness, and prompted opioid discontinuation in 25% of cases

Riemsma (2011) (166) Systematic review of tapentadol in chronic severe pain

136

10 RCTs involving severe pain, and 42 for moderate and severe pain

With metaanalysis

Nociceptive or neuropathic, malignant or nonmalignant, severe pain, or moderate/sev ere pain

Tapentadol

Oxycodone and placebo

Pain intensity, pain relief (30% and 50%, patient global impression of change, quality of life, quality of sleep, discontinua tions, as well as serious adverse events and selected

For moderate to severe pain, 42 relevant trials were identified for comparisons with transdermal buprenorphine,tran sdermal fentanyl, hydromorphone, morphine, and oxymorphone were made Treatment with tapentadol was statistically significant over oxycodone for pain intensity, 30% and

Chronic Pain Health Needs Assessment

Comments

effects

Benefit to risk ration of tapentadol appears to be improved compared to strong opioids

Cochrane review PRISMA:4 items missing AMSTAR: Good

Level 1

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

adverse events

OCEBM level

Comments

Level 1

The evidence base for the use of opioid or topical

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

50% pain relief, patient global impression of change, and quality of life Adverse effects of opioid treatment were significantly less frequent with tapentadol compared to oxycodone. Discontinuation was significantly reduced wit tapentadol treatment

Manchikanti (2011) (167) A systematic review of

23 RCTs were included

With metaanalysis

Chronic Pain Health Needs Assessment

Adults aged at least 18 years with pain due to

Any opioid administered either orally or topically, any

Placebo treatment

Minimum of 12 weeks of follow-up,

Fentanyl and oxymorphone showed trends similar to tapentadol Fair evidence for the use of tramadol in management of osteoarthritis. For

137

Evidence for all drugs assessed, including tramadol, for all

Not Cochrane review PRISMA: 7

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

randomised controlled trials of long-term opioid management for chronic noncancer pain

Wiffen (2011) (169) Lamotrigine for acute and chronic pain

138

12 RCTs, 1511 participants

With metaanalysis

any cause other than cancer lasting for at least 3 months prior to trial enrolment, and previously failed nonopioid pharmacothe rapy treatment

dose for at least 12 weeks

Central post stroke pain, chemotherap y induced neuropathic pain, diabetic neuropathy, HIV related neuropathy, mixed neuropathic

Lamotrigine

Placebo or active control

Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

all drugs assessed, including tramadol, for all other conditions, the evidence was poor

other conditions was poor and based on weak positive evidence, indeterminate evidence or negative evidence

items missing

Patient reported pain relief of 50% or greater, patient reported global impression of clinical change,

No study evaluated lamotrigine in acute pain

This update confirmed with further evidence from a larger pool of studies and subjects the earlier conclusion that lamotrigine is not effective in

Cochrane review

Chronic Pain Health Needs Assessment

Comments

PRISMA â&#x20AC;&#x201C; items not reported

pain relief (average change in pain scores, proportion of patients with at least 50% pain relief, health related QOL and function)

There is no convincing evidence that lamotrigine is effective in treating chronic pain at doses of about 200400 mg daily.

OCEBM level

AMSTAR:Good

PRISMA:No items missing AMSTAR:Good

Level1

opioids is generally poor. If these agents are used at all in chronic pain then patient reported outcomes and evaluation of benefit must guide the decision whether to continue to use them Lamotrigine does not have a significant place in therapy and should not be commissione d as treatment for any type of chronic pain

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

pain, spinal cord injury,related pain, trigeminal neuralgia

Wiffen (2011) (170) Carbamazepine for acute and chronic pain in adults

15 RCTs (12 cross-over and 3 parallel group studies), 629 participants

With metaanalysis

Chronic Pain Health Needs Assessment

Trigeminal neuralgia, post herpetic neuralgia, diabetic neuropathy, HIV related neuropathy, central post

Carbamazepine

Placebo or active control

pain on movement, pain on light touch , pain on rest, any other pain related measure, adverse effects within a subgroup analysis of the elderly if data were available Patient reported pain relief of 50% or greater, patient reported global impression

Almost 10% of participants taking lamotrigine reported a skin rash

treating chronic pain

Five studies with 298 participants showed carbamazepine to be better than placebo. Using any grade of improvement the response was 70%

Carbamazepine is effective in chronic neuropathic pain but with caveats

139

Comments

Level 1

Carbamazepi ne treatment should be commissione d but only for neuropathic pain and then only for selected

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

Cochrane review PRISMA:3 items missing AMSTAR: Good

Quality of trials, duration of

OCEBM level

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

stroke pain, irritable bowel, and temporoman dibular joint dysfunction pain

of clinical change, pain on movement, pain on rest or spontaneo us pain, any other pain related outcomes, adverse events

with carbamazepine v. 12% with placebo (event rate ratio or relative benefit 6.1 (95% CI 3.9 to 9.7), NNT 1.7 (95% CI: 1.5 to 2.0). Four studies (188 participants) reporting outcomes equivalent to 50% pain reduction or more over baseline had a similar NNT Side-effects were frequent. 66% of participants on carbamazeoine experienced at least one adverse event, vs 27% with placebo; relative risk 2.4 (95% CI 1.9 to 3.1); NNH 2.6 (95% CI: 2.1 to 3.5). Adverse event

140

Chronic Pain Health Needs Assessment

follow up and reporting of outcomes were all poor therefore, caution is needed in interpretation, and meaningful comparison with other interventions is not possible

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability patients

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

OCEBM level

Comments

Level 1

Further large studies of longer duration examining specific cannabinoids in homogeneou s populations are needed before firm conclusions can be drawn

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

withdrawals occurred in 12 of 323 participants (4%) with carbamazepine and 0 of 310 with placebo.

Lynch (2011) (168) Cannabinoids for treatment of chronic noncancer pain: a systematic review of randomised controlled trials

18 RCTs

Without metaanalysis

Chronic noncancer pain

Cannabinoids

Placebo or active control group

Pain reduction (VAS),Neur opathiy pain scale, McGill pain scale

Five deaths occurred in patients on carbamazepine, with no obvious drug association A significant analgesic effect of cannabinoid as compared with placebo was reported by 15 of the 18 trials, and several reported significant improvements in sleep. There were no serious adverse

Chronic Pain Health Needs Assessment

141

There is evidence that cannabinoids are safe and modestly effective in neuropathic pain with preliminary evidence of efficacy in fibromyalgia and rheumatoid arthritis

Not Cochrane review PRISMA:11 items missing AMSTAR: Good

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

OCEBM level

Comments

Level 2?

Included studies had heterogeneo us patient populations and study designs. Studies were of poor quality, were small, and enrolled a variety of different refractory

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

effects. Adverse effects most commonly reported were generally well tolerated, mild to moderate in severity and led to withdrawal from the studies in only a few cases

Plested (2010) (171) Pregabalin, the lidocaine plaster and duloxetine in patients with refractory neuropathic pain: a systematic review

17 trials

Without metaanalysis

Refractory neuropathic pain due to any cause, lower back pain with a neuropathic component

Pregabalin, lidocaine plaster, and duloxetine

Pain intensity (VAS)

Sensory and affective scores (McGill pain questionnaire ), function interference, sleep interference, pain associated distress

9/17 studies were for pregabalin, 7/17 were for lidocaine plaster, and one study for duloxetine.

Not Cochrane review PRISMA: 10 items missing AMSTAR:Good

Only 6 studies included treatments within UK licensed indications and dose ranges Reported efficacy outcomes were

142

Indeterminate or of limited effect

Chronic Pain Health Needs Assessment

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

inconsistent between studies.

neuropathic conditions

Significant improvements in total, sensory and affective Short-form McGill pain questionnaire in all studies, and in function interference, sleep interference, and pain associated distress with pregabalin treatment.

Further research required

Only one of three studies for lidocaine plaster reported statistical significance for reduction of pain intensity. One study for

Chronic Pain Health Needs Assessment

OCEBM level

143

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

duloxetine showed that pain severity (VAS) was statistically reduced at endpoint compared to baseline Limited or no QOL data available for lidocaine plaster or duloxetine Pregabalin showed efficacy benefits in patients with neuropathic pain inadequately controlled by gabapentin Adverse events were poorly reported 6 studies reported withdrawals for pregabalin and 4

144

Chronic Pain Health Needs Assessment

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

OCEBM level

Comments

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

OCEBM level

Comments

Level 1

Although effective, adverse effects are associated with treatment. Further analysis of evidence is required

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

studies for lidocaine plaster. No data was available for duloxetine Tzellos (2010) (172) Gabapentin and pregabalin in the treatment of fibromyalgia: a systematic review and a meta-analysis

4 RCTs (2040 participants)

With metaanalysis

Chronic Pain Health Needs Assessment

Adults aged 18 and over with Fibromyalgia

Gabapentin and pregabalin

placebo

>30% pain reduction, percentage of dropouts due to lack of efficacy

Pregabalin at a dose of 600, 450 and 300 mg per day is effective in FBM compared to placebo (NNT: 7, upper 95% CI: 12, 450 mg). A number of adverse events (AE), such as dizziness, somnolence, dry mouth, weight gain, peripheral oedema, is consistently associated with treatment at any dose and could lead one out of four patients to quit

145

Pregabalin at a dose of 450mg per day is effective in treatment of fibromyalgia

Not Cochrane review PRISMA:2 items missing AMSTAR:Good

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

Siler (2011) (173) Systematic review of the comparative effectiveness of

146

8 studies (7 for pregabalin, 1 for gabapentin)

With metaanalysis

Fibromyalgia

Any antiepileptic drug

Placebo

Impact on pain (the proportion of patients with response,

treatment (NNH: 6, lower 95% CI: 4, 600 mg). Indirect comparison metaanalysis suggests that PB at a dose of 450 mg per day could result in more responders than at 300 mg, but this result needs to be interpreted with caution as there were no significant differences between 600 and 300 mg or between 600 and 450 mg. Data on GP is limited Both drugs reduced mean pain scores more than placebo at a modest rate (pregabalin, 38% to 50%;

Chronic Pain Health Needs Assessment

Moderate benefit in shortterm

OCEBM level

Comments

Level 1

Pregabalin and gabapentin can be used for treatment of

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

Not Cochrane review PRISMA:6 items missing

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

antiepileptic drugs for fibromyalgia

Moore (2011) (174) Gabapentin for chronic neuropathic pain and fibromyalgia in adults

change in pain score from baseline, functional status, or sleep quality) and adverse events

29 RCTs (3571 participants)

With metaanalysis

Chronic Pain Health Needs Assessment

Painful diabetic neuropathy, post herpetic neuralgia, trigeminal neuralgia, phantom limb pain, postoperative or traumatic neuropathic

Gabapentin in any dose, by any route

Placebo, no intervention, or any other active comparator

Patient reported pain intensity reduction of 30% or greater.

Any painrelated outcome indicating some improvement .

Patient reported pain intensity

Withdrawals due to lack of efficacy. Participants

gabapentin, 51%). In a 6-month trial of pregabalin responders, 32% continued to have response at 6 months, with a mean time to loss of response of 34 days. Compared to placebo, the drugs had similarly high rates of adverse events and withdrawals Twenty-nine studies (3571 participants), studied gabapentin at daily doses of 1200 mg or more in 12 chronic pain conditions; 78% of participants were in studies of post herpetic neuralgia, painful diabetic neuropathy or

147

OCEBM level

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability AMSTAR:Good/ medium

Gabapentin is effective treatment for painful neuropathic pain

Comments

Cochrane review PRISMA: No items missing AMSTAR: Good

fibromyalgia in the shortterm, but studies are required to assess long term benefits of pregabalin and gabapentin

Level 1

Results of pain relief may vary between neuropathic pain conditions, as well as dose of gabapentin Gabapentin should be

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

pain, complex regional pain syndrome, cancerrelated neuropathy, HIVneuropathy, spinal cord injury, fibromyalgia

reduction of 50% or greater.

experiencing any adverse event.

Patient reported global impression of clinical change (PGIC) much or very much improved.

Participants experiencing any serious adverse event.

Patient reported global impression of clinical change (PGIC) very much improved

Specific adverse events, particularly somnolence and dizziness

Withdrawals due to adverse events.

mixed neuropathic pain. Using the IMMPACT definition of at least moderate benefit, gabapentin was superior to placebo in 14 studies with 2831 participants, 43% improving with gabapentin and 26% with placebo; the NNT was 5.8 (4.8 to 7.2). Using the IMMPACT definition of substantial benefit, gabapentin was superior to placebo in 13 studies with 2627 participants, 31% improving with gabapentin and 17% with placebo; the NNT was 6.8 (5.6 to 8.7) Adverse events

148

Chronic Pain Health Needs Assessment

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability commissione d but for selected patients

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

OCEBM level

Comments

Level 1

Capsaicin seems to be effective in providing clinically

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

occurred significantly more often with gabapentin. Persons taking gabapentin can expect to have at least one adverse event (66%), withdraw because of an adverse event (12%), suffer dizziness (21%), somnolence (16%), peripheral oedema (8%), and gait disturbance (9%). Serious adverse events (4%) were no more common than with placebo Derry (2009) (220)Topical capsaicin for chronic neuropathic

9 RCTs (1600 participants)

With metaanalysis

Chronic Pain Health Needs Assessment

Adults with neuropathic pain of at least moderate

Topical capsaicin (low dose formulation <0.1%)

Placebo or other active treatment

Clinical improveme nt of at least 50% reduction

Numbers of participants with adverse events: local, systemic and

Six studies (389 participants in total) compared regular application of low dose (0.075%)

149

Effective

Cochrane review PRISMA: one item missing

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

pain in adults

150

intensity resulting from any cause, with a duration of at least three months

in pain, patient reported global assessment of treatment, pain on movement, pain on rest or spontaneo us pain, undefined improveme nt

cough Numbers of withdrawals: all cause, lack of efficacy and adverse effects

capsaicin cream with placebo cream; the NNT for any pain relief over six to eight weeks was 6.6 (4.1 to 17). Two studies (709 participants in total) compared a single application of high dose (8%) capsaicin patch with placebo patch; the NNT for _ 30% pain relief over twelve weeks was 12 (6.4 to 70). Local skin reactions were more common with capsaicin, usually tolerable, and attenuated with time; the NNH for repeated low dose application was 2.5 (2.1 to 3.1). There were

Chronic Pain Health Needs Assessment

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

AMSTAR: Good

useful relief (but at the expense of local skin irritation) from various neuropathic pain conditions alone or in combination with other treatment in patients who fail to respond to or cannot tolerate other available therapies

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect

Noble (2010) (214) Long-term opioid management for chronic noncancer pain (update of 2008)

One RCT and 26 pre-post case studies (27 treatment groups, 4893 participants)

With metaanalysis

Chronic Pain Health Needs Assessment

Adults with pain due to any cause other than cancer lasting from at least three months prior to enrolment. Previous nonopioid pharmacothe rapy must have failed before beginning

Any opioid taken by any route in any dose for at least six months

No comparator

Adverse effects, discontinua tion from study due to adverse effects, discontinua tion due to insufficient pain relief, average change in pain score, proportion of patients

insufficient data to analyse either data set by condition or outcome definition. All studies satisfied minimum criteria for quality and validity, but maintenance of blinding remains a potential problem. Many participants discontinued due to adverse effects (oral: 22.9% [95% confidence interval (CI): 15.3% to 32.8%]; transdermal:12.1% [95% CI: 4.9% to 27.0%]; intrathecal: 8.9% [95% CI: 4.0% to 26.1%]); or insufficient pain relief (oral: 10.3% [95% CI: 7.6% to 13.9%]; intrathecal:

151

OCEBM level

Comments

Level 4

Weak evidence suggests that patients able to continue opioids longterm experience clinically significant pain relief

PRISMA â&#x20AC;&#x201C; items not reported

Likely to be ineffective or potentially harmful

Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

Some long-term benefit

Cochrane review PRISMA: two items missing AMSTAR: Medium

Inconclusive evidence for quality of life and /

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

opioids

with at least 50% pain relief, healthrelated QoL

7.6% [95%CI: 3.7% to 14.8%]; transdermal: 5.8%[95% CI: 4.2% to 7.9%]) Signs of opioid addiction were reported in 0.27% of participants in the studies that reported that outcome. All three modes of administration were associated with clinically significant reductions in pain, but the amount of pain relief varied among studies Findings regarding quality of life and functional status were inconclusive due to an insufficient quantity

152

Chronic Pain Health Needs Assessment

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability functional improvement Many minor adverse events (like nausea and headache) occurred, but serious adverse events, including iatrogenic opioid addiction, were rare Long term opioids should be commissione d but their use should be restricted to selected patients in view of the

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

Gill (2011) (221) Valproic acid and sodium valproate for neuropathic pain and fibromyalgia in adults

3 RCTs (2 were in diabetic neuropathy (total 84 subjects with 42 on placebo and 42 on valproate; one study was in post-herpetic neuralgia (23 active and 22 placebo)

Without metaanalysis

Chronic Pain Health Needs Assessment

Adults with one or more of the following chronic neuropathic conditions: painful diabetic neuropathy, post-herpetic neuralgia, trigeminal neuralgia, phantom limb pain, postoperative or traumatic

Valproic acid or sodium valproate in any dose, by any route, administered for the relief of neuropathic pain or fibromyalgia

Placebo, no intervention, or any other active comparator

Patientreported pain relief of 30% or greater Patientreported pain relief of 50% or greater

Any painrelated outcome indicating some improvement

Patientreported PGIC much or very much improved

Participants experiencing any adverse event

Withdrawals due to lack of efficacy.

Participants experiencing

of evidence for oral administration studies and inconclusive statistical findings for transdermal and intrathecal administration studies The primary outcome â&#x20AC;&#x201C; 50% or more pain relief was reported only in 1 study, while all 3 reported group means for pain reduction from baseline to endpoint. 1 study in diabetic neuropathy and the study in post-herpetic neuralgia reported significant differences in favour of valproic acid. Pooled analysis not

153

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability lack of conclusive evidence of benefit

Likely to be ineffective

Cochrane review PRISMA: three items missing AMSTAR: Medium

Level 1

These results hint at a beneficial effect of valproic acid. The effect may have been overestimate d because the studies did not analyse the data on an intention to treat basis. Evidence does not

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

Straube (2011) (222) Interference with work in fibromyalgia: effect of treatment with pregabalin and relation to pain response

154

4 RCTs

Metaanalysis

neuropathic pain, complex regional pain syndrome, cancerrelated neuropathy, Guillain Barré, HIVneuropathy spinal cord injury, fibromyalgia Adults with fibromyalgia

Patientreported PGIC very much improved

any serious adverse event Withdrawals due to adverse events Specific adverse events, particularly somnolence and dizziness

Pregabalin

Placebo

Pain improveme nt (0-10 numerical pain rating scale score at beginning of trial and end of trial pain state (VAS 100mm

OCEBM level

PRISMA – items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

possible due to insufficient data. Adverse events (nausea, drowsiness and abnormal liver function tests were reported more often in active treatment group

All patients improved but those on pregabalin saw greater reduction in days lost. Days of work lost in placebo group fell from a mean of 2.2 (SD 2.3) days to 1.9 (SD 2.1) days at trial end (p < 0.01). Patients on 600 mg pregabalin saw a reduction

Chronic Pain Health Needs Assessment

Comments

justify the use of valproic acid or sodium valproate in neuropathic pain

Effective

Not Cochrane review PRISMA: 13 items missing AMSTAR: Low (some questions not applicable)

Level 1

This metaanalysis shows that effective pain relief translates into other benefits – in this case a return to work A reduction

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

pain scale)

from 2.1 (SD 2.2) days to 1.6 (SD 2.0) days (p < 0.001) Patients with a good pain response saw the best improvement in days lost from work: from 2.0 (SD 2.2) days to 0.97 (SD 1.6) days (p < 0.0001) for those experiencing >/= 50% pain improvement and from 1.9 (SD 2.2) days to 0.73 (SD 1.4) days (p < 0.0001) for those achieving a low level of pain at trial end (<30 mm on the VAS) Patients achieving both >/= 50% pain improvement and a pain score <30 mm

Chronic Pain Health Needs Assessment

155

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability of more than a day a week in time off work can be achieved in patients with good pain responses

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminate or of limited effect Likely to be ineffective or potentially harmful

on the VAS had the largest improvement, from 2.0 (SD 2.2) days to 0.60 (SD 1.3) days (p < 0.0001)

156

Chronic Pain Health Needs Assessment

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

OCEBM level

Comments

Appendix 3

Link to main document Summary of findings: Patient education

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Gross (2012) (175) Patient education for neck pain

15 RCTs

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect

With metaanalysis

Neck pain associated with whiplash or non-specific and specific mechanical neck pain with or without radiculopathy or cervicogenic headache

Therapeutic patient education

Placebo (sham/mock education strategy), other treatment added to both arms of trial, wait list or no treatment, another treatment

Pain intensity, function, disability, knowledge transfer, behaviour change

QOL, global perceived effect, patient satisfaction. Adverse effects, follow-up

Moderate quality evidence (one trial, 348 participants) than an educational video of advice focussing on activation was more beneficial for acute whiplash related pain vs no treatment at intermediate-term (RR=0.79; 95%CI:0.59, 1.06) but not longterm follow-up (0.89; 95%CI: 0.65, 1.21) Low quality evidence (one trial, 102 participants) that whiplash pamphlet on advice focusing on activation is less beneficial for pain

Chronic Pain Health Needs Assessment

157

Likely to be ineffective or potentially harmful With exception of one trial, this review has not shown effectiveness for educational interventions, including advice to activate, advice on stresscoping skills, workplace ergonomics and self-care strategies

OCEBM level

Comments

Level 1

The evidence available does not support the commissioning of education based interventions for neck pain

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability Cochrane review PRISMA: one item missing AMSTAR: Good

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

Haines (2009) (223) Patient education for neck pain with or without radiculopathy

158

10 RCTs

with metaanalysis

Adults with neck pain with or without radiculopathy

Patient education

Placebo (sham/mock education strategy) or other treatment (eg sham TENS), other treatment added to both arms of the trial (eg education and ultrasound versus ultrasound), waiting list control or no

Pain relief, function/disability, global perceived effect, QoL, patient satisfaction, follow up

reduction, or no different in improving function and global perceived improvement from generic information given out in emergency care (control) for acute whiplash at short or intermediate term follow-up Of the 10 trials, two trials were of high quality, 8 trials focussed on activation compared to no treatment or to various active treatments, including therapeutic exercise, manual therapy, and CBT, showed inferiority or no difference for pain, spanning a full range of follow-up periods and disorder types. Two trials showed no benefit for chronic neck pain and stress

Chronic Pain Health Needs Assessment

Limited effect

OCEBM level

Comments

Level 1

The review has not shown effectiveness for educational interventions in various disorder types and follow-up periods, including advice to activate, advice on stress coping skills, and 'neck school'. In future research, further

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

Cochrane review PRISMA: one item missing AMSTAR: Medium

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful treatment, or another treatment (eg education versus another intervention, one technique of education versus another, or one dose of education versus another dose)

Chronic Pain Health Needs Assessment

coping skills at intermediate/longterm follow-up. One trial compared effects of traditional neck school to no treatment, yielding limited evidence of no benefit for pain at intermediate-term follow-up in mixed acute/subacute/ chronic neck pain

159

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability attention to methodological quality is necessary. Studies of multimodal interventions should consider study designs, such as factorial designs, that permit discrimination of the specific educational components

Appendix 4

Link to main document Summary of findings: Physical treatments

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

Chow (2009) (183) Efficacy of low level laser therapy in the management of neck pain: a systematic review and meta-analysis of randomised placebo or activetreatment controlled trials

160

16 RCTs included

With metaanalysis

Acute neck pain Chronic neck pain

Low level laser therapy

Placebo or active treatment

Reduction in pain intensity (VAS)

Acute neck pain: results of two trials showed RR of 1.69 (95% CI: 1.22-2.33) for pain improvement of LLLT vs placebo Chronic neck pain: 11trials reported changes in VAS and pain intensity reduced by 19.86mm (95% CI:10.04-29.68) 5 trials reported RR for pain improvement of 4.05 (95% CI: 2.74-5.98) of LLLT

Chronic Pain Health Needs Assessment

Moderate statistical significance for efficacy of LLLT for acute/chronic neck pain in short and medium term For chronic neck pain, average reduction of VAS of 19.86mm

OCEBM level

Comments

Level 1

These results must be seen as preliminary evidence. Further trials are required

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneit y, size of effect estimate and precision, generalizabili ty Not Cochrane review PRISMA: 4 missing items AMSTAR: Good

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

OCEBM level

Comments

Level 1

Further larger trials required to confirm clinical benefit, LLLT cannot be recommende d

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneit y, size of effect estimate and precision, generalizabili ty

across all studies was considered clinically relevant

Mark (2010) (177) Low level laser therapy for carpal tunnel syndrome and chronic neck pain

6 randomised controlled trials included

Without metaanalysis

4 studies included

Chronic Pain Health Needs Assessment

Chronic neck pain, carpal tunnel syndrome

Low level laser therapy

Sham treatment

Pain relief on VAS, McGill pain questionnaire, neck pain and disability score, functionality

Chronic neck pain: studies showed variable results. Two studies showed statistically significant findings for primary outcome of change in VAS score. Two studies showed changes in VAS

161

Clinical benefits of LLLT occur both when LLLT is used as monotherapy and in the context of regular exercise and stretching programme Treatment should be regarded as experimental due to poor methodological quality and variability of

Not Cochrane review PRISMA:11 items missing AMSTAR: Low

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

Alexander (2010) (178) Exposure to low amounts of ultrasound energy does not improve soft tissue shoulder pathology: a systematic review

8 RCTs included

Graham (2008) (179) Mechanical traction for neck pain with

7 RCTs included

162

Without metaanalysis

Shoulder pain

Ultrasound

Control treatment

Pain reduction

Quality of life, functionality

but not statistically significant. Two studies showed no difference between treatments Three studies produced significantly better outcomes compared to control groups

Neck pain with or without radiculopathy

Mechanical traction alone or in combination with other

Placebo or another treatment

Pain relief using the VAS score, NRS.

Functional or disability measures including work-related

No evidence from RCTs that supports or rejects use of either continuous or intermittent traction for neck pain

Chronic Pain Health Needs Assessment

Comments

Level 1

Optimal parameters for effectiveness of ultrasound is not known, it would be premature to conclude that this treatment is ineffective. More research is required Requires further well conducted RCTs to determine

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneit y, size of effect estimate and precision, generalizabili ty

results and small sample size Indeterminate, optimal ultrasound energy not known

Two studies reported significantly reduced pain and significant improvements in function

With metaanalysis

OCEBM level

Not Cochrane review PRISMA:8 items missing AMSTAR:Goo d/medium

Indeterminate

Cochrane review PRISMA:6 items missing

Level 1

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

or without radiculopathy

Warden (2008) (180) Patellar taping and bracing for the treatment of chronic knee pain: a systematic review and meta-analysis

treatments

7 RCTS included 9 randomised cross-over studies

With metaanalysis

Chronic Pain Health Needs Assessment

Chronic knee pain

Patellar taping and/or bracing

disability, return to work, patient satisfaction, global perceived effect and quality of life No taping or bracing

Pain relief using 100 mm VAS score

OCEBM level

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneit y, size of effect estimate and precision, generalizabili ty efficacy of traction. Recommenda tions cannot be made with the available evidence

AMSTAR:Goo d

On 100mm scale, pain decreased with tape application (95%CI:22.2 to 10;P<0.001) compared to no tape and sham tape by 10.9mm (95%CI:-18.4 to 3.4; P<0.001) Anterior knee pain and OA, pain decreased with medially-directed tape compared with no tape by 14.7mm (95%CI:-22/8 to -6.9; P<0.001) and 20.1 mm (95%CI:-26.0 to 14.3; P<0.001) respectively

163

Evidence for mediallydirected force on patella Limited evidence to demonstrate efficacy of patellar bracing

Comments

Not Cochrane review PRISMA:2 items missing AMSTAR:Goo d

Level 1

Outcomes limited by presence of high heterogeneit y between study outcomes and significant publication bias

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

Blum (2008) The H-wave

5 studies included but not clear what type of studies included 2 studies included disproportion ately large populations; one study had 1291 participants and the other had 5132 participants

With metaanalysis

Neuropathic pain and soft tissue inflammation

H-wave electrical stimulation

No treatment

Pain reduction and reduction in use of pain medication

For chronic soft tissue inflammation and neuropathic pain: Decreased pain ratings, mean weighted effect size=0.59, estimated effect size=0.00003 (95%CI:0.580, 0.600) Decreased intake of pain medication, mean weighted effect size=0.56, estimated effect size variance=0.000013(95%CI :0.553, 0.567) Improved patient functionality, mean weighted effect size=0.70, estimated effect size variance=0.00002 (95%CI:0.691, 0.709) Chi2 test for homogeneous effect sizes

164

Chronic Pain Health Needs Assessment

Strong to moderate effect in providing pain relief, reducing medication requirement and increasing functionality. May facilitate quicker return to work and other related daily activities

OCEBM level

Comments

Not clear

Systematic review is of poor quality, based on uncontrolled studies and little reliance can be based on the reported beneficial effect of Hwave device

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneit y, size of effect estimate and precision, generalizabili ty Not Cochrane review PRISMA:5 items missing AMSTAR:Low /medium

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

OCEBM level

Comments

Level 1

The clinical effect of back school, LLLT, patient education, massage, traction, superficial heat/cold, and lumbar supports is not clear due to insufficient

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneit y, size of effect estimate and precision, generalizabili ty

highly significant variability (P<0.00001), indicating a robust significant effect size for increased functionality relative to both pain relief and reductions in pain medication.

Van Middelkoop (2011) (182) A systematic review on the effectiveness of physical and rehabilitation interventions for chronic nonspecific low back pain

83 RCTs (8816 participants)

With metaanalysis

Chronic Pain Health Needs Assessment

Adults older than 18 years with nonspecific chronic LBP that persisted for 12 weeks or more

Physical and rehabilitation intervenetion s

No treatment, waiting list controls, other interventions

Pain and physical functional status (pain intensity (VAS, McGill pain questionnaire), back specific disability (ODI), perceived recovery, return to work, side effects)

Little to no evidence of any adverse effects Exercise therapy versus usual care: exercise treatment improved posttreatement pain intensity and disability and longterm function BT versus no treatment/waiting list: BT was more effective in reducing pain intensity at short-term follow-up compared to no

165

Overall evidence from RCTs, effectiveness of treatments was low. Exercise versus usual care, quality of evidence was low

Not Cochrane review PRISMA:6 items missing AMSTAR: Good to medium

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

treatment/waiting list controls MDT versus no treatment/waiting list controls: MDT reduced pain intensity and disability at short-term follow-up compared to no treatment/ waiting list control

166

Chronic Pain Health Needs Assessment

BT versus no treatment/waiti ng list control, quality of evidence was low MDT versus no treatment/waiti ng list control, evidence of effectiveness was moderate at short-term at reducing pain in cLBP

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneit y, size of effect estimate and precision, generalizabili ty data. Only MDT, exercise and BT have some effect on pain intensity and disability, thus only these three interventions should be provided as conservative treatments in daily practice in the treatment of cLBP

Appendix 5

Link to main document Summary of findings: Behavioural and cognitive behavioural therapy

Summary of findings for systematic reviews Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminat e or of limited effect Likely to be ineffective or potentially harmful

Eccleston (2009) (224) Psychological therapies for the management of chronic pain (excluding headache) in adults

40 RCTs (4781 participants)

With metaanalysis

Chronic Pain Health Needs Assessment

Adults reporting non-cancer pain of at least three months duration in any body site, with neck facial or dental pain

Cognitive behavioural therapy, behavioural therapy

Placebo other active treatment, treatment as usual, or waiting list control

Pain experience, negative mood, disability

Overall lack of evidence for BT, except for pain immediately following treatment, when compared to TAU CBT has some small effects for pain, disability and mood

Insufficient data on quality or content of treatment to investigate their influence on outcomes CBT and BT may have a positive effect on altering mood outcomes but results are not statistically

167

OCEBM level

Comments

Level1

CBT and BT have weak effects in improving pain

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability Cochrane review PRISMA: 2 items missing AMSTAR: good

Both interventions may be effective in altering mood outcomes and the effect may be maintained at 6 months The evidence for

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminat e or of limited effect Likely to be ineffective or potentially harmful

OCEBM level

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

significant

Macea (2010) (185) The efficacy of webbased cognitive behavioural interventions for chronic pain: a systematic review and

168

11 randomised trial studies, 2953 participants

With metaanalysis

Adults with chronic pain

Internet-based cognitive behavioural programmes, with or without minimal therapist contact for patients in treatment of

Waiting list group

Pain improvement

Results of this metaanalysis suggest that web-based interventions for chronic pain effect are associated with small reductions in pain in the interventions group compared with waiting-list control groups

Chronic Pain Health Needs Assessment

The effect of web-based psychological interventions is weak and uncertain

Comments

behavioural therapies in isolation is weak and is not sufficient to commission these services as individual interventions

Not Cochrane review PRISMA- 6 items missing AMSTAR: Good

Level 2

There is a role for CBT as part of a comprehensi ve multidisciplinary programme In view of the small effect and the likely bias, webbased behavioural therapy should not be commissione d

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminat e or of limited effect

meta-analysis

OCEBM level

Comments

Level 1

Results provide support for efficacy of psychological interventions in reducing self-reported pain, painrelated interference, depression, disability, and increasing HRQOL in

PRISMA â&#x20AC;&#x201C; items not reported

Likely to be ineffective or potentially harmful

Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

Effective for CBT

Not Cochrane review

Although the review methodology was generally good, it was unclear which studies were contributing to the metaanalyses and whether there was

PRISMA: 5 items missing

chronic pain The 11 studies showed wide variability in the type of assessments that were used, the study population, the aetiology of chronic pain, and time of intervention

Hoffman (2007) (186) Metaanalysis of psychological interventions for chronic low back pain

34 RCTs,

Metaanalysis

Chronic Pain Health Needs Assessment

Adults with noncancerous cLBP

Psychological interventions

Waiting list control or treatment as usual

Pain intensity, QOL, physical and emotional functioning

Drop-out rate from the study was 26% 3 or 4 RCTs (depending on outcome) for CBT versus waiting list controls: There was significant reduction in pain intensity at posttreatment in favour of CBT but not at follow-up (time not specified). No significant differences for HRQOL or depression (post â&#x20AC;&#x201C;treatment only stated). 3 or 4 RCTs (depending on outcome) for CBT

169

AMSTAR: Good

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminat e or of limited effect Likely to be ineffective or potentially harmful

versus self-regulatory treatment: there was a significant reduction in pain intensity and depression in favour of CBT at follow-up (time not specified) but not at post-treatment

Henschke (2010) (187) Behavioural treatment for chronic lowback pain

170

30 RCTs (3438 participants)

Without metaanalysis

Adults with nonspecific chronic low back pain that had persisted for 12 weeks or more

Combined behavioural treatment (respondent, operant and cognitive, behavioural therapy) + physiotherapy, behavioural therapy+ inpatient rehabilitation

Waiting list controls, usual care, group exercise, other treatment

Self-reported or observed overall improvement , back-pain specific functional status (Rowland Morris questionnaire or ODI), generic functional status, return

For most comparisons, there was only low or very low quality evidence to support the results. There was moderate quality evidence that:i) operant therapy was more effective than waiting list (SMD -0.43; 95%CI 0.75 to -0.11) for shortterm pain relief;ii) little or no difference exists between operant, cognitive, or combined

Chronic Pain Health Needs Assessment

clinical heterogeneit y. RCTs of variable quality; authors comment on lack of reporting on treatment fidelity and concurrent treatments Only CBT showed significant difference between waiting list control for short-term pain control Other comparisons : likely to be ineffective

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability patients with CLBP. Psychological interventions could be commissione d for the treatment of CLBP

Cochrane review PRISMA: 2 items missing AMSTAR: Good

Level 1

For patients with CLBP, there is moderate quality evidence that in the shortterm, operant therapy is more effective than waiting list and behavioural therapy is

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminat e or of limited effect Likely to be ineffective or potentially harmful

to work, pain intensity (VAS or NRS)

Chronic Pain Health Needs Assessment

behavioural therapy for short- to intermediateterm pain relief;iii) behavioural treatment was more effective than usual care for shortterm pain relief (MD 5.18; 95%CI -9.79 to 0.57), but there were no differences in the intermediate- to longterm, or on functional status;iv) there was little or no difference between behavioural treatment and group exercise for pain relief or depressive symptoms over the intermediateto long-term;v) adding behavioural therapy to inpatient rehabilitation was no more effective than inpatient rehabilitation alone

171

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability more effective than usual care for pain relief, but no specific type of behavioural therapy is more effective than another. In the intermediateto long-term, there is little or no difference between behavioural therapy and group exercises for pain or depressive symptoms. CBT should

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Excluded Indeterminat e or of limited effect Likely to be ineffective or potentially harmful

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability be commissione d as part of a multidisciplin ary programme

172

Chronic Pain Health Needs Assessment

Summary of Findings: Guidelines Citation Guideline: Care pathway domain and topic PICOT summary

Guideline evidence: Study design Searching and study selection

Low back pain. Early management of persistent non-specific low back pain. CG 88; 2009(156) Treatment: BT and CBT: CBT

Pop: People aged 18 or older with symptoms of non-specific low back pain (LBP) which has not resolved within 6weeks of initial onset, consultation or exacerbation up to a period of 12 months. Int: CBT Comp: Usual care in general practice, pamphlet, information package Out: Pain Study designs: RCTs Searching: Comprehensive search strategy. Studies were selected which matched the inclusion/exclusion criteria. Validity: Each paper was assessed for quality and critically appraised using the Instituteâ&#x20AC;&#x2122;s criteria for quality assessment.

Validity Guideline evidence:

Harms

1 RCT: No significant differences between groups in terms of pain or fear avoidance (follow-up time not stated). 1 RCT: Greater reduction in average pain intensity for the self care group but difference significant only at 6 mths.Significantly lower fear avoidance scale scores in the self care group at all follow-up times. Significantly less disability in self care group at 3 mths but not 6 or 12 mths.No more favourable mental health outcomes in self care group.

Cost effectiveness GRADE assessment

High

Outcomes: Benefits

Did evidence justify recommendations

Yes

Chronic pain health needs assessment 173

Appendix 6.

Link to main document Summary of findings: Invasive procedures

Summary of findings: systematic reviews Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

Straube (2010) (206) Cervicothoracic or lumbar sympathect omy for neuropathi c pain

1 study satisfied inclusion criteria, 4 others were excluded

Adults with peripheral or central neuropathic pain syndromes and complex regional pain syndrome.

Chronic pain health needs assessment

Radiofrequency thermal ablation Sympathectomy (Cx-thoracic or lumbar)

Chemical sympathectomy using Phenol injection

Subjective Pain scores, no binary outcomes reported

% patients with <30% or mild pain relief, pain relief of <4 weeks duration, adverse events, occurrence of persistent new or expanded pain

1 RCT included. 20 patients, 10 in each arm, Both groups sign reductions in pain scores (from 89/10 to 4/10 and remained at 3-5 out of 10 over 4 months.

174

Both types of sympathectomy seem equally efficacious but comparisons with sham procedure is lacking. Small sample size. Soreness at injection site lasted 5-7 days. Paresthesia in 2 patients in Rf group and 1 in phenol group. Number with serious adverse events not

OCEBM level

Comments

Level 2

Sympathectomy is based on little high quality evidence. Other evidence suggests that it can work at least in some cases. Should be used with caution if at all, outside a research context.

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability Cochrane review PRISMA: 5 items missing AMSTAR:Good

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

Hayek (2011) (195) Intrathecal therapy for cancer and non-cancer pain

Vlassakov (2011) (208) Local

15 studies for nonnon cancer pain. Of the manuscript reviewed 5 were cancer pain related and 39 were excluded

12 included studies: single case

Not applicabl e

Adults with various forms of chronic non-cancer pain

Neuralgias, radicular pain syndromes

Chronic Pain Health Needs Assessment

Intrathecal drug delivery

Nerve blocks with local anaesthetics

Does not apply since all 15 studies were observational in nature

No comparator

Pain relief defined as a 2 point drop in 11 point pain scale, or a decrease of 30% on baseline pain intensity

Pain relief

Function improvement, reduction in oral medication, QoL changes, decrease in side effects from oral drugs

The included noncancer studies were generally poorly reported. Most reported modest improvements in patient reported pain scores as measured by a visual analogue score Adverse events ranged from no cases in some studies to 23/136 in one study with some studies reporting substantial rates of removal. Rare but serious complications include infection and granuloma There were no controlled studies. Nine reports

175

reported. Intrathecal infusion of drugs using in implantable programmable system is supported by level 2c grade of evidence (lowest of 6 possible grades used by Guyatt), and is suggested that other alternative treatments may be equally reasonable

All reviewed articles were single case

OCEBM level

Comments

Level 3

The available evidence base does not justify the commissioning of this treatment in any but the most exceptional circumstances.

Level 4

More research efforts are warranted.

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

Not Cochrane review PRISMA:11 items missing AMSTAR:Good/ medium

Not Cochrane review

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

anaesthetic blockade of peripheral nerves for treatment of neuralgias: systematic analysis

reports or case series

Benyamin

3 RCTs and

176

associated with chronic pain or more than a 3month duration

Without

Chronic mechanical

Cervical epidural

Comparator not

Pain relief

Psychological

assessed a single block outcome. All reported pain relief beyond the duration of conduction blockade. The nine studies represented a total of 69 patients, 30 of whom had complete pain relief and 10 had at least 50% relief. Seven reports assessing continuous pain for more than 1 week after single block reported complete or profound pain relief in 11 of 17 patients. All 3 reports assessing series of blocks in a large number of patients (270) reported overall positive results Studies were at level

Chronic Pain Health Needs Assessment

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

reports or case series, no reliable conclusion could be drawn concerning the effectiveness of nerve blocks with local anaesthetics in neuralgia. However, two features of the analysed reports-the large magnitude of the effect and the high consistency of the reported outcome

PRISMA:13 items missing

A significant

Not Cochrane

Cannot justify commissioning on the basis of evidence provided in the study

AMSTAR:Good/ medium

Level 2

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

(2009) (211) Systematic review of the effectivene ss of cervical epidurals in the manageme nt of chronic neck pain Ypsilantis (2010) (209) Preemptive analgaesia for chronic limb pain after amputation for peripheral vascular disease: a

17 observatio nal studies

11 studies (7 RCTs, 2 casecontrol studies, 2 prospective observatio nal cohort studies)

metaanalysis

Without metaanalysis

or whiplash-related neck pain with or without radiculopathy for at least 3 months

Chronic stump pain and PLP (critical ischaemia of peripheral vascular disease)

Chronic Pain Health Needs Assessment

injections with or without steroids

Pre-emptive analgaesia (local) anaesthetics, opiates, Nmethyl-Daspartate receptor agonists, a2agonists, gammaaminobutyric acid analogues administered separately or in

indicated

Comparator not indicated in review

functionalit y

Pain relief

improvement, return to work, change in opioid intake

Comments

Level 1 (7/11 studies were RCTs)

Not recommended for commissioning

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

2 (evidence obtained from well designed controlled trials without randomisation) in managing chronic neck and upper extremity pain with 1C (strong recommendation, low quality or very low quality evidence)

effect was observed in relieving chronic intractable pain of cervical origin and providing longterm relief with an indicated evidence level of II-1 on the AHRQ

review

11 studies, five different types of analgesic drugs evaluated. Beneficial effect of combined bupivacaine, diamorphine, and clonidine in reducing the risk of phantom limb pain was supported by only one study (level 3

There is no robust evidence to support the use of preemptive analgesia to minimise risk of chronic pain after amputation for critical ischaemia of peripheral

Not Cochrane review

177

OCEBM level

PRISMA:7 items missing AMSTAR:good/ medium

PRISMA:14 items missing AMSTAR:Good/ medium

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

systematic review

Staal (2008) (205) Injection therapy for subacute and chronic low back pain

178

combinations, through the oral, invtravenous, epidural, or regional route

18 RCTs (1179 participant s)

Metaanalysis not possible

Patients with low back pain with symptoms persisting for at least 1 month, Subacute low back pain lasting for 4 weeks or longer and chronic pain as lasting for 12 weeks or longer

Epidural injections, facet joint injections (intra-articular, peri-articular, and nerve blocks), tender and trigger point injections using drugs consisting of

evidence), epidural and perineural infusions containing local anaesthetic +/opiates are effective in treating acute perioperative pain, although not without potentially serious complications

Placebo

Pain relief or improveme nt

Global measure of improvement, back-specific disability, generic health status or wellbeing, disability for work, patient satisfaction

Most studies characterised by high dropout rates because of diseaserelated mortality Facet joint injections with corticosteroid vs placebo: One RCT (Carette 1991) showed no significant difference at 3 months. Differences at 6 months described as statistically significant (self-rated

Chronic Pain Health Needs Assessment

OCEBM level

Comments

Level 1

There is insufficient evidence to support use of injection therapy in subacute and chronic low back pain, but may be beneficial to a

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

vascular disease. The methods used are effective in treating acute post operative pain

Statistical pooling was not possible because of clinical heterogeneity in the trials. Results indicate that there is no strong evidence for or against

Cochrane review PRISMA:4 items missing AMSTAR:Good

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

corticosteroids, local anaesthetics, and a variety of other drugs

improvement, pain, and functional status in favour of active treatment) One RCT(Lilius 1990) showed no statistical differences between groups for pain, disability or work attendance at 1 hour, 2 weeks, 6 weeks and 3 months (corticosteroid injected intraarticularly, corticosteroids injected pericapsularly and placebo injections) Facet joint injections with corticosteroids vs other treatments: 4RCTs: Manchikanti (2001) showed no significant

Chronic Pain Health Needs Assessment

179

the use of any type of injection therapy Adverse events were either not reported or there were no complications reported. Only 3 RCTs were of high quality

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability subgroup of patients who may respond to a specific type of injection therapy

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

differences for pain relief, overall health, physical, functional and psychological status and return to work throughout a 2.5 yr follow-up period (facet joint injections with corticosteroids, local anaesthetics, and Sarapin vs similar injections with local anaesthetics and Sarapin) Mayer (2004) showed no significant posttreatment differences for pain or disability (facet joint injections with mixtures of local anaesthetics and corticosteroids) with a home stretching exercise programme vs exercise

180

Chronic Pain Health Needs Assessment

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

OCEBM level

Comments

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

programme only Marks (1992) showed significant difference in favour of facet joint injections (compared to facte nerve blocks) at 1 month, but not at posttreatment, 2 weeks or 3 months, for pain relief. No difference for disability scores or work attendance Fuchs (2005) Showed no significant difference for pain relief, disability or QOL over a 180-day period (facet joint injections with sodium hyaluronate vs injections with corticosteroids)

Chronic Pain Health Needs Assessment

181

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

OCEBM level

Comments

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

Datta (2009) (192) Systematic assessment of diagnostic

182

7 studies included, consecutiv e or nonconsecutiv e allocation and

Without metaanalysis

Chronic low back pain

Lumbar facet joint interventions

Placebo or comparative local anaesthesic block under fluoroscopy

For diagnostic interventio ns: Pain relief was categorise d as at

For diagnostic interventions: measures of improvement in functional status, psychological

Facet joint injections with local anaesthetics vs other treatments: 1 RCT, Ravel (1999) showed significantly higher pain relief post treatment with facet joint injections with lidocaine compared to injections with saline. In both groups these injections were followed with an injection of corticosteroids. Other outcomes were not measured Diagnostic lumbar facet joint nerve blocks: Study 1: 500 patients evaluated for facet joint pain, 397 were evaluated for low

Chronic Pain Health Needs Assessment

OCEBM level

Comments

Level 5

Strong recommendatio ns for lumbar facet joint injections and radiofrequency neurotomy

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

Lumbar facet joint and radiofrequency neurotomy are effective

Not Cochrane review

Lumbar intra-

AMSTAR:Mediu

PRISMA:5 items missing

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

accuracy and therapeutic utility of lumbar facet joint interventio ns

observatio nal studies

least 80% pain relief from baseline pain and ability to perform previously painful movement For therapeuti c interventio ns: shortterm pain relief (lasting 6 months or less) and long-term relief (lasting longer than 6 months)

Chronic Pain Health Needs Assessment

statusm return to work, reduction in opioid intake

back pain (prevalence 31%; 95%CI: 27%, 36%; false positive rate with single blocks with lidocaine: 95%CI: 22%, 32%)) Study 2: 438 patients evaluated of which 303 patients had lumbar pain (prevalence 27%; 95%CI: 22%, 33%) with a false-postive rate of single blocks in the lumbar region of 45% (95%CI: 36%, 53%) Study 3: zygapophysial joint pain in 20 patients (32%; 95%CI: 20% to 44%) obtained â&#x2030;Ľ50% pain relief after saline treatment.

183

articular injections likely to be ineffective

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability m/good Very weak recommendatio n for lumbar intra-articular injections

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

OCEBM level

Comments

Level 1 (majority of studies were RCTs)

Further evidence is required before definitive conclusions can be drawn

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

23/57 patients who completed the study failed to obtain pain relief after saline injection but obtained relief with one or more intraarticular local anaesthetic Study 4: 120 patients with low back pain were evaluated for facet nerve blocks, provocative discography, and sacroiliac joint injections. Facet joint Zhang (2011) (210) The efficacy of botulinum toxin type A in managing

184

14 RCTs and 1 crossover study

With metaanalysis

Shoulder pain, whiplash, plantar fasciitis, tennis elbow, myofascial pain

Intra-muscular or subcutaneous botulinum toxin A (single or complementary therapy)

Placebo, nonactive injection or other treatments in reducing chronic musculoskeletal pain (e.g. exercise)

Duration of pain severity, disease of interest, dosing regimen, length of

Small to moderate pain reduction among BoNTA patients when compared to control (SMD= -0.27; 95%CI: -0.44, -0.11)

Chronic Pain Health Needs Assessment

BoNTA had a small to moderate analgesic effect in chronic musculoskeletal pain conditions, especially in

Not Cochrane review PRISMA:4 items missing AMSTAR:Good

The evidence

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

chronic musculoske letal pain: a systematic review and metaanalysis

follow-up

Subgroups, only tennis elbow (SMD= -0.44; 95%CI: 0.86, 0.01) and plantar fasciitis (SMD= -1.04; 95% CI: -1.68, -0.40) demonstrated significant pain relief One back pain study also demonstrated positive results for BoNTA

Langevin (2011) (199) Botulinum toxin for subacute/c hronic neck pain

9 randomise d and quasirandomise d trials

With metaanalysis

Sub-acute/chronic non-specific neck pain/mechanical neck pain

Chronic Pain Health Needs Assessment

Botulinum toxin A intra-muscular injections alone or in addition to another treatment (e.g., exercise)

Placebo or another active treatment (ultrasound)

Patient reported pain, function, disability, QOL, global perceived effect and satisfaction

High quality evidence for little or no difference in pain between BoNTA and saline injections at four weeks (five trials; 252 participants; SMD pooled -0.07 (95% confidence intervals (CI) -0.36 to 0.21)) and six months for

185

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

plantar fasciitis, tennis elbow and back pain, but not in whiplash or shoulder patients

does not support commissioning of this treatment

Studies were small with follow-up between 4 to 24 weeks

Likely to be ineffective at 4 weeks and 6 months for chronic pain

Cochrane review PRISMA: 1 item missing AMSTAR:Good

Level 1

This evidence fails to confirm either a clinically important or a statistically significant benefit of BoNT-A injection for chronic neck pain associated

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

chronic neck pain. Very low quality evidence of little or no difference in pain between BoNT-A combined with physiotherapeutic exercise and analgesics compared to saline injection with physiotherapeutic exercise and analgesics for patients with chronic neck pain at four weeks (two trials; 95 participants; SMD pooled 0.09 (95% CI -0.55 to 0.73)) and six months (one trial; 24 participants; SMD -0.56 (95% CI -1.39 to 0.27)). Very low quality evidence from one

186

Chronic Pain Health Needs Assessment

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability with or without associated cervicogenic headache. Likewise, there was no benefit seen for disability and quality of life at four week and six months

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect

OCEBM level

Comments

Level 1

High risk of bias demands

PRISMA â&#x20AC;&#x201C; items not reported

Likely to be ineffective or potentially harmful

Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

Indeterminate or of limited

Cochrane review

trial (32 participants) of little or no difference between BoNT-A and placebo at 4 weeks (SMD 0.16 (95% CI -0.53 to 0.86)) and six months (SMD 0.00 (95% CI -0.69 to 0.69)) for chronic cervicogenic headache.

Singh (2010)

6 RCTs (164 participant

With meta-

Shoulder pain due to any cause

Chronic Pain Health Needs Assessment

Botulinum toxin injection by any

Placebo injection or another active

Pain measured

Function or disability, joint

Very low quality evidence from one trial (31 participants), of benefit from BoNT-A in global perceived effect in chronic neck pain at four weeks (SMD -1.12 (95% CI: -1.89 to 0.36)). A single injection of BoNT-A (v placebo)

187

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

(204) Botulinum toxin for shoulder pain

analysis

route, including, but not limited to intramuscular, subcutaneous, intradermal or intra-articular routes

treatment

on a VAS or semiquantitativ e scale Adverse effects, total and serious; number of withdrawal s due to adverse events, and deaths

range of motion, QOL, patient or physician evaluated success of treatment, radiographic progression for patients with shoulder arthritis, stroke patient disability

significantly reduced pain at three to six months postinjection (MD -1.2 points, 95% CI -2.4 to -0.07; 0 to 10 point scale) but not at one month (MD 1.1 points, 95% CI 2.9 to 0.7) in post stroke shoulder pain. Shoulder external rotation was increased at one month (MD 9.8Â°, 95% CI 0.2 to 19.4) but not at three to six months. Shoulder abduction, external rotation or spasticity did not differ between groups, nor did the number of adverse events (RR 1.46, 95% CI 0.6 to 24.3). One RCT in arthritis-

188

Chronic Pain Health Needs Assessment

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

effect PRISMA:1 item missing AMSTAR:Good

caution. Botulinum toxin A injections seem to reduce pain severity and improve shoulder function and range of motion when compared with placebo in patients with shoulder pain due to spastic hemiplegia or arthritis It is unclear if the benefit of pain relief in post-stroke shoulder pain at three to six months but not at one month is due to limitations of evidence, which

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

OCEBM level

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

related shoulder pain indicated that botulinum toxin reduced pain severity (MD -2.0, 95% CI -3.7 to -0.3; 10 point scale) and shoulder disability with a reduction in Shoulder Pain and Disability Index score (MD -13.4, 95% CI 24.9 to -1.9; 100 point scale) when compared with placebo. Shoulder abduction was improved (MD 13.8 degrees, 95% CI 3.2 to 44.0). Serious adverse events did not differ between groups (RR 0.35, 95% CI: 0.11, 1.12) Kalichman (2011)

4 RCTs

With meta-

Lateral epicondylitis

Chronic Pain Health Needs Assessment

Botulinum toxin injections

Placebo

Level of pain

Meta-analysis of 4 RCTs showed a

189

Comments

includes small sample sizes with imprecise estimates, or delayed onset of action. More studies with safety data are needed

Indeterminate or of limited

Not Cochrane review

Level 1

Present literature

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

(198) Injection of botulinum toxin for treatment of chronic lateral epicondyliti s:Systemati c review and metaanalysis

Ho (2007) (196) Botulinum toxin A for myofascial trigger point injection: a qualitative systematic

190

analysis

5 clinical trials

Without metaanalysis

reduction, grip strength

Chronic myofascial pain

Trigger point injections

Placebo

Pain intensity, pain pressure threshold

moderate effect for pain favoring botulinum toxin (effect size -0.5, 95% CI: -0.9,-0.1) at 3 months and no effect for grip strength Qualitative analysis of studies that could not be pooled also showed improvement in pain, but was limited by potential bias No data presented on safety. One trial with 14 and 12 patients with a saline control arm concluded that BoNTA was effective, while four other trials (sample sizes ranging from 22 to 66 in both arms) concluded

Chronic Pain Health Needs Assessment

OCEBM level

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

effect

provides support for use of botulinum toxin A injections into fore arm extensor muscles (60 units) for treatment of chronic treatmentresistant lateral epicondylitis

PRISMA: 5 items missing AMSTAR:Good

Indeterminate or of limited effect

Comments

Not Cochrane review PRISMA: 12 items missing AMSTAR: Medium/good

Level 1

Current evidence does not support the use of BTA injection in trigger points for myofascial pain. The evidence

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

review

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

that Botulinum toxin injection was not better than saline injection in improving the pain.

does not support commissioning this treatment

Of the studies excluded from this review many were open label trials that claimed superior efficacy for botulinum toxin. The included studies were all small in size and methodologically Scott (2009) (202) Trigger point injections for chronic non-

15 RCTs

Without metaanalysis

Chronic nonmalignant musculoskeletal pain

Chronic Pain Health Needs Assessment

Trigger point injections

Placebo or no treatment

Pain reduction, pain pressure, subjective function, medication usage

weak. Detailed results from RCTs presented. 10 of 15 studies had very small sample sizes. Internal validity ranged from good to poor.

191

Likely to be ineffective

Not Cochrane review PRISMA: 4 items missing AMSTAR:Good

Level 1

Efficacy not proven. Only advantage of including local anaesthetic in the injection appears to be to

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

malignant musculoske letal pain: a systematic review

Patel (2009) (201) Systematic review of intrathecal infusion systems for long-term manageme nt of chronic non-cancer pain

192

15 observatio nal studies

Without metaanalysis

Chronic non-cancer pain

Intrathecal infusion devices

At least 50% pain relief

Improvement of function, reduction amount of oral medication, decrease in side effects from systemic drugs, improvement in QOL

In general, regardless of the drug injected trigger point injection was no more effective than other less invasive treatments such as laser and ultrasound Of 4 observational studies, only two studies showed positive results for short- and long-term relief. The studies included were regarded as strongly recommended by authors, but low quality or very low quality evidence Study showed that benefits of intrathecal infusion devices outweighed

Chronic Pain Health Needs Assessment

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability reduce the pain of the needling The evidence available does not support commissioning this treatment

Indeterminate or of limited effect.

Not Cochrane review PRISMA:8 items missing AMSTAR:Mediu m/good

Level 2

Although this study strongly recommended intrathecal devices for management of chronic noncancer pain, there were limitations to the study, including paucity of literature, lack of quality of evidence and lack of

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

OCEBM level

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

risk and burdens Chua (2011) (191) Pulsed radiofrequ ency treatment in interventio nal pain manageme nt: mechanism s and potential indicationsa review

6 RCTs for PRF

Without metaanalysis

Zygapophyseal joint pain, cervical radicular pain, lumbosacral pain, trigeminal neuralgia, chronic shoulder pain

Chronic Pain Health Needs Assessment

Pulsed radiofrequency

Corticosteroid injection, sham intervention, conventional radiofrequency thermocoagulati on

Global perceived effect (>50%), pain reduction using VAS, disability

Cervical radicular pain: one study showed significant improvement (>50%) of global perceived effect and VAS (NNT=3 in sham group and NNT =1,1 in PRF group). After 6 months, NNT for sham intervention=6, PRF group=1.6 Lumbar zygapophyseal joint pain: One RCT showed PRF against RF denervation to have comparable results at 6 months, reduced pain scores maintained at 1 yeear only for the RF group.

193

Evidence shows that PRF may be of benefit in treatment of cervical radicular pain and chronic shoulder pain, but less effective for lumbar zygapophyseal joint pain and trigeminal neuralgia

Comments

Not Cochrane review PRISMA:13 items missing AMSTAR:Mediu m

Level 1

randomised controlled trials Further research is required to warrant use of PRF for the treatment of chronic pain

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

Another RCT showed no significant difference between RF and PRF groups in improvement of pain scores. Over a three month interval, RF showed significant improvement in VAS score (but potential bias due to lack of blinding, lack of numbers of withdrawals, and patients lost to follow-up) Lumbosacral radicular pain: one RCT showed no significant difference in VAS between PRF only group and PRF+RF group, no significant neurological deficits. Loss of analgesic effect between 2 to

194

Chronic Pain Health Needs Assessment

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

OCEBM level

Comments

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

4 months. By month 8, majority of patients returned to baseline pain intensity Trigeminal neuralgia:one RCT showed significant pain reduction in all patients treated with RF, while only 2/20 patients in the PRF group experienced the same level of pain relief. Chronic shoulder pain: one RCT for intra-articular corticosteroid injection vs suprascapular nerve RF showed significant improvements up to three months in

Chronic Pain Health Needs Assessment

195

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

OCEBM level

Comments

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

Dretzke (2011) (193) The clinical and costeffectivene ss of neurostimu lation for relief of chronic/ne

196

Two RCTs for SCS

Without metaanalysis

FBSS, CRPS

SCS

Conventional medical treatment

Pain reduction by at least 50%

Functional ability, EQ-5D improvement

terms of pain scores, range of motion, and QOL. Patients in the intra-articular corticosteroid injections had improved pain scores and shoulder disability scores compared to suprascapular nerve RF. In another study, suprascapular nerve RF has been shown to be effective up to 6 months FBSS: One trial (PROCESS) reported at least 50% pain reduction at 6 months compared to patients receiving conventional medical management and the effect was

Chronic Pain Health Needs Assessment

SCS for FBSS: Effective, statistically significant SCS for CRPS I: effective, statistically significant

OCEBM level

Comments

Level 1

FBSS: Evidence suggests that SCS is more effective than conventional medical management or re-operation in terms of pain relief. SCS may be more

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

Not Cochrane review

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

uropathic pain: an evidence based review

sustained at 12 months follow-up and 24 months follow-up. Functional ability was measured by ODI which improved significantly for the SCS group and was sustained at 24 months compared to patients receiving conventional medical management, and between group differences were significant. There was no difference in the use of opiate, other analgesic, or antidepressant between the SCS group and the CMM group. Another trial (North)

Chronic Pain Health Needs Assessment

197

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability effective at improving function and HRQOL. Two RCTs reported device-related complications, but were minor. Incidence of AEs upon removal of the SCS device was low, and number of device related incidences fall after the first year. Other complications included infections, and cerebrospinal fluid leakage. CRPS I: Evidence from a small but

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

reported significantly higher positive outcomes in the SCS group, with 39% reporting at least 50% improvement in pain scores alone. The mean follow-up for this trial was 2.9 years. Patient-self reported neurological function was generally worse at long-term follow-up in the re-operation group compared to the SCS group, although differences were not statistically significant. An increase in opiate use in 42 % of patients of the the re-operation group compared to 13% in the SCS group was

198

Chronic Pain Health Needs Assessment

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability well-conducted RCT suggests a significant reduction in pain and significant improvement in global perceived effect at 6 months and two years. The effect on quality of life at any time-point is not known.

SCS should be commissioned for use for those patients who fail to respond to other treatments

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

also reported. CRPS I: patients implanted with SCS reported a significant reduction in pain as measured by VAS at 6 months and 2 years. Similar changes were also observed for global perceived effect, which diminished at the three year time point, and at 5 years there were no longer any significant differences between standard therapy groups and SCS groups. SCS did not appear to influence HRQOL or functional status. Patient satisfaction was high in those patients who received a

Chronic Pain Health Needs Assessment

199

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

OCEBM level

Comments

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

Simpson (2009) (203) Spinal cord stimulation for chronic pain of neuropathi c or ischaemic origin: systematic review and economic evaluation

200

11 RCTs

With metaanalysis

Adults with chronic neuropathic or ischaemic pain who have had inadequate response to medical or surgical treatment other than SCS

Spinal cord stimulator devices

Medical and/or surgical treatment (appropriate to condition) that does not include spinal cord stimulation

Pain, health related QOL, physical and functional abilities, anxiety and depression , medication use, complicati ons and adverse effects (eg, procedural complicati ons and technical failures

permanent implant. Of 11 RCTs (three for neuropathic pain and eight of ischaemic pain), trials were available for FBSS and CRPS type I. SCS was found to be more effective than conventional medical management or reoperation in reducing pain. Evidence failed to show that effectiveness for SCS in critical limb pain relief compared to conventional medical management. SCS was effective in delaying refractory angina pain onsest at short term followup but no more than

Chronic Pain Health Needs Assessment

Evidence suggested that SCS was effective in reducing the chronic neuropathic pain of FBSS and CRPS type I. For ischaemic pain, there may need to be selection criteria developed for CLI, and SCS may have clinical benefit for refractory angina in the short term

OCEBM level

Comments

Level 1

Further studies required for other types of neuropathic pain or subgroups of ischaemic pain

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

Not Cochrane review PRISMA:11 items missing AMSTAR: Medium/good

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

Ibrahim (2009) (197) Surgical versus nonsurgical treatment of chronic low back pain: a metaanalysis of randomise d trials

4 RCTs (634 participant s)

Metaanalysis

Chronic low back pain

Spinal fusion with or without instrumentation

Physical therapy with or without cognitive therapy

Painrelated disability( Owestry disability index), daily life and social participatio n

Patient satisfaction, return to work

coronary artery bypass grafting. Complications varied from study to study, but were usually minor 3 RCTs compared surgical vs nonsurgical treatment for low back pain short-term. All studies were of good methodological quality. Pooled results showed a trend in favour of surgery (mean ODI difference=4.13; P=0.10; 95%CI: -0.48 to 9.17) Heterogeneity in surgical techniques, analysis had limitations due to paucity of studies. The only outcome

Chronic Pain Health Needs Assessment

201

Limited benefit

OCEBM level

Comments

Level 1

Surgical fusion may improve ODI compared to non-surgical intervention at 2 years followup, but effect was not statistically significant. Spinal fusion can only be recommended cautiously to patients with chronic low back pain. Further long term follow up of studies is required.

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

Cochrane review PRISMA: 4 items missing AMSTAR:Good

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

Van den Eerenbeem t (2010) (207) Total disc replaceme nt surgery for symptomat ic degenerati ve lumbar disc disease: a systematic review of the literature

202

19 studies (16 prospective cohort, 3 prospective controlled studies, 3 RCTs)

Without metaanalysis

Chronic low back pain

Total disc replacement surgery

Lumbar fusion

Pain intensity (VAS), functional status, global improvem ent, return to work

Physiological outcome, radiological outcome, patient satisfaction

measure examined was ODI, and other outcomes were not addressed which could limit conclusions. Possible publication bias due to small number of studies Charite trial (artificial disc) was considered to have a low risk of bias for 2 year follow-up and was non-inferior to the BAK interbody fusion system (57.1 vs 46.5% for 2 year follow-up; 57.8 vs 51.2% for 5 year follow-up). There were no statistically significant differences in mean pain and physical function scores. The prodisc artificial disc was found to be

Chronic Pain Health Needs Assessment

Not of benefit due to low quality evidence

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

Not Cochrane review PRISMA: 8 items missing AMSTAR:Mediu m/good

Level 3 (majority of studies were cohort studies)

Current evidence does not support routine use of surgery for treatment of chronic low back pain There are no long-term studies to test the longevity of the prostheses evaluated in this study. Current evidence does not support routine use of surgery for the treatment of chronic low back pain

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

statistically more effective compared to lumbar circumferential fusion, but risk of bias was high. Flexicore trial: high risk of bias, no clinical relevant There were no statistically significant difference in mean pain and physical function scores.differences on pain and physical function compared to circumferential spinal fusion at 2 year follow-up. No conclusions can be drawn from the study

Chronic Pain Health Needs Assessment

203

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

OCEBM level

Comments

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

Asher (2010) (190) Auriculothe rapy for pain manageme nt:a systematic review and metaanalysis of randomise d controlled trials

204

17 studies (8 perioperati ve, 4 acute, and 5 chronic pain)

With Metaanalysis

All chronic pain and acute pain types

Auriculotherapy

Sham, placebo, or standard care control

Pain reduction, medication use

17 studies met inclusion criteria (8 perioperative, 4 acute, and 5 chronic pain). Auriculotherapy was superior to controls for studies evaluating pain intensity (SMD, 1.56 [95% confidence interval (CI): 0.85, 2.26]; 8 studies). For perioperative pain, auriculotherapy reduced analgesic use (SMD, 0.54 [95% CI: 0.30, 0.77]; 5 studies). For acute pain and chronic pain, auriculotherapy reduced pain intensity (SMD for acute pain, 1.35 [95% CI:

Chronic Pain Health Needs Assessment

Effective, but significant heterogeneity existed for acute and chronic pain groups analysed except for perioperative subgroup.

OCEBM level

Comments

Level 1

Auriculotherapy may be effective for treatment of various pain types, further large, welldesigned trials are required

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability Not Cochrane review PRISMA: 1 item missing AMSTAR:Good

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

OCEBM level

Comments

Level 1

Lumbar fusion may be more effective for treatment of chronic back pain than nonoperative care Lumbar fusion may not be more effective than structured rehabilitation including CBT

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

0.08, 2.64], 2 studies; SMD for chronic pain, 1.84 [95% CI: 0.60, 3.07], 5 studies) Mirza (2007) (200) Systematic review of randomise d trials comparing lumbar fusion to nonoperative care for treatment of chronic back pain

5 RCTs, 4 of which focused on nonspecific chronic back pain

Chronic back pain

Chronic Pain Health Needs Assessment

Lumbar fusion surgery

Non-operative care

Pain reduction VAS), disability

All trials enrolled similar subjects. One study suggested greater improvement in back-specific disability for fusion compared to unstructured nonoperative care at 2 years, but the trial did not report data according to intent-to-treat principles. Three trials suggested no substantial difference in disability scores at 1year and 2-years when fusion

205

Moderately effective over non-surgical care

Not Cochrane review PRISMA:9 items missing AMSTAR:Mediu m

Methodological limitations of RCTs prevent firm conclusions about lumbar fusion

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Gibson (2008) (225) Surgical interventio ns for lumbar disc prolapse

40 RCTs and two Quasi-RCTs (5197 participant s)

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect

Without metaanalysis

Patients with lumbar prolapsed disc who have indications for surgical intervention

Discectomy, microdiscectomy, chemonucleolysis , automated percutaneous discectomy, nucleoplasty, and laser discectomy

Conservative treatment

Selfreported pain relief Resolution or improvem ent in pain Disability/ QOL

206

Summary Finding

Measures of objective physical impairement (spinal flexion, improvement in straight leg raise, alteration in muscle power, change in neurological

was compared to a 3-week cognitive behaviour treatment addressing fears about back injury. However, 2 of these trials were underpowered to identify clinically important differences. The third trial had high rates of cross-over (20% for each treatment) and loss to follow-up (20%) Of 40 RCTs, only 4 trials directly compared discectomy with conservative management, but was not conclusive. Other trials showed that discectomy produced better outcomes than chemonucleolysis

Chronic Pain Health Needs Assessment

OCEBM level

Comments

Level 1

Further research is required, weak evidence, insufficient data to draw any conclusions about effectiveness of any of the surgical treatments

PRISMA â&#x20AC;&#x201C; items not reported

Likely to be ineffective or potentially harmful

Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

Some positive effect

Cochrane review PRISMA:6 items missing AMSTAR:Good/ medium

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

Return to work Rate of subsequen t back surgery

Chronic Pain Health Needs Assessment

signs) Adverse complications( early: damage to spinal cord, cauda equine, dural lining, nerve root or any combination, infection, vascular injury, allergic reaction to chymopapain, medical complications, death. Late: chronic pain, altered spinal biomechanics, instability or both, adhesive arachoiditis, nerve root dysfunction,

(which was better than placebo) Microdiscectomy gave broadly comparable results to standard discectomy Information on many trials was limited, but included recurrence of symptoms, need for additional surgery, and allergic reactions Many of the trials had design weaknesses that could lead to bias

207

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability investigated. Surgical discectomy should not be commissioned for routine use, but only in carefully selected patients with sciatica due to lumbar disc prolapse

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

OCEBM level

Comments

Level 1

Studies assessed as low and high quality, but potential biases in some studies including performance bias, and detection bias. High drop-out rates in MRC trial, and missing data.

PRISMA – items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

myelocele recurrent disc prolapsed) Cost data Chou (2009) (176) Surgery for low back pain

208

84 studies (4 RCTs 2 SRs)

With metaanalysis

Adults 18 years and over with low back pain of any duration, alone or with leg pain

Surgery

Non-surgical interventions

Back specific function, generic health status, pain, work disability or patient satisfaction

Fusion versus nonsurgical therapy/nonradicular low back pain with common degenerative changes: Swedish lumbar spine study (n=294) statistically significant results in favour of surgery for (i) ‘excellent’ or ‘good’ assessment by independent assessors; (ii) patient ratings (‘better’ or ‘much better’), (iii) pain (VAS score) and (iv) proportion returning

Chronic Pain Health Needs Assessment

Effective, statistically significant

Not Cochrane review PRISMA: AMSTAR: medium

Trials for decompressive surgery were assessed as high quality but a high proportion of patients did

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

to work MRC spine stabilisation trial (n=349) statistically significant improvements in ODI after 24 months but difference not considered clinically significant (NB this trial included 11% of patients with spondylolisthesis and 15% had nonfusion surgical treatment) Two smaller trials (n=60, n=64) found no significant differences on any main outcomes after one year (trend towards slightly improved outcomes with surgery in one

Chronic Pain Health Needs Assessment

209

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability not adhere to treatment. Lack of long-term studies, so benefits not known. Fair evidence exists that is in favour of surgery over non-surgical treatment, but should only be commissioned for treatment in highly selected patients who fail all other treatments and with caution. Patients should be made aware of implications of surgery.

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

trial) In the latter three trials, non-surgical treatment consisted of intensive rehabilitation incorporating CBT; in the Swedish study the non-surgical treatment was less intensive and more heterogeneous. There were differences in inclusion criteria between trials One SR (Ibrahim 2008) pooled three of the above trials (one small trial not identified) and found the difference on the ODI to be (just) non-significant (trend towards favouring surgery). Other outcomes

210

Chronic Pain Health Needs Assessment

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

OCEBM level

Comments

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

were not pooled. Artificial disc replacement versus fusion. Chronic nonradicular back pain with single level degenerative disc disease: 2 RCTs found that artificial disc was not inferior to anterior lumbar inter body fusion on a composite outcome of ‘clinical success’ at 24 months; no statistically significant differences in mean ODI, VAS, or rates of employment at 24 months. Another study found artificial disc to be superior to circumferential fusion on a

Chronic Pain Health Needs Assessment

211

PRISMA – items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

OCEBM level

Comments

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

composite outcome of success after 24 months; no statistically significant differences in mean ODI, pain score or SF-36 scores. NB: trial was designed as a non-inferiority trial, but appears to have been analysed as a superiority trial Discectomy versus non-surgical therapy for radiculopathy with prolapsed lumbar disc: one RCT for open discectomy found that surgery was associated with lower likelihood of poor results (statistically significant) after one year, but not long term. A higher

212

Chronic Pain Health Needs Assessment

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

OCEBM level

Comments

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

quality trial found no differences between treatments but there was very poor treatment adherence in on treatment analyses adjusted for confounders, surgery was found to be moderately superior (statistically significant at one to two years) NB, technique left at discretion of surgeons (open or microdiscectomy). Microdiscectomy: two trials found surgery to be moderately superior to non-surgical treatment at 6-8 weeks, but not long term (26 weeks). In

Chronic Pain Health Needs Assessment

213

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

OCEBM level

Comments

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

both trials around 40% of patients in control arms eventually underwent surgery, which could potentially affect results (reduce benefit of surgery) in an intention-to-treat analysis. A further two trials are identified that find surgery to be more effective than more conservative management, at least in the shorter term (up to 18 months in one trial). Decompressive surgery: laminectomy versus non-surgical therapy for symptomatic spinal stenosis (+/-

214

Chronic Pain Health Needs Assessment

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

OCEBM level

Comments

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

degenerative spondylolisthesis): two trials found moderate benefits (ODI, pain, good result) in favour of surgery, mainly up to one year. Two larger trials found few differences between surgery and non-surgical therapies over two years, but almost half of patients did not adhere to treatment assignment. Decompressive surgery: interspinous spacer device versus nonsurgical therapy for symptomatic spinal stenosis: Two trials found that an

Chronic Pain Health Needs Assessment

215

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

OCEBM level

Comments

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Intervention

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminate or of limited effect Likely to be ineffective or potentially harmful

interspinous spacer device was substantially superior to nonsurgical treatment in terms of overall treatment success at two years. One trial found lower rates of subsequent laminectomy with the interspinous spacer device, the other found no difference in rates.

216

Chronic Pain Health Needs Assessment

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneity, size of effect estimate and precision, generalizability

OCEBM level

Comments

Chronic Pain Health Needs Assessment

217

Summary of Findings: Guidelines Citation

Low back pain. Early management of persistent non-specific low back pain. CG 88; 2009(156)

Guideline: Care pathway domain and topic

Treatment: Invasive procedures: Facet joint injections

PICOT summary

Pop: People aged 18 or older with symptoms of non-specific low back pain (LBP) which has not resolved within 6 weeks of initial onset, consultation or exacerbation up to a period of 12 months. Int: Facet joint injections of methylprednisolone acetate (isotonic saline). Comp: Usual care in general practice. Out: Pain scores; disability scores; psychological distress; safety; adverse events Study designs: Systematic reviews and RCTs Searching: Comprehensive search strategy. Studies were selected which matched the inclusion/exclusion criteria. Validity: Each paper was assessed for quality and critically appraised using the Instituteâ&#x20AC;&#x2122;s criteria for quality assessment.

Guideline evidence: Study design Searching and study selection Validity Guideline evidence: Outcomes: Benefits Harms Cost effectiveness GRADE assessment Did evidence justify recommendations

Based on 1 RCT: After 1 month: none of the outcomes evaluating pain, functional status and back flexion differed statistically between the groups. At 6 months: more improvement, less pain (VAS score) and less physical disability in the treatment group 1-6 months: sustained improvement in 22% (active) v 10% (placebo), not stat. sig (p=0.19) Injections are of little value in treating Chronic LBP.

High Yes

Comments Summary of Findings: Guidelines Citation

Percutaneous endoscopic laser lumbar discectomy. NICE IPG 300;2009 and Overview document(212,226).

Guideline: Care pathway domain and topic

Treatment: Invasive procedures: Surgery: Percutaneous endoscopic laser lumbar discectomy

PICOT summary

Pop: Symptomatic lumbar disc prolapse Int: Percutaneous endoscopic laser lumbar discectomy Comps: Usual care Out: Success rates (MacNab score); pain; mobility

Guideline evidence: Chronic pain health needs assessment 218

Study design

Study designs: Case series Searching: Comprehensive search strategy Validity: Validity is commented on but no method stated.

Searching and study selection Validity Guideline evidence: Outcomes: Benefits Harms Cost effectiveness

Efficacy 3 case series a) (n=300). Return to work and increased mobility in 67%, reduced pain medication in 32% (those with central prolapsed, n=279) b) (n=67). VAS leg pain and score on Oswestry Disability Index improved at 18 months (significantly for ODI); 88% with good or excellent results at final follow-up. c) (n=43). 81% of patients with good or excellent outcome (MacNab criteria) Safety a) Reoperation in 2%, psoas haematoma in <1% and sympathetic medicated pain in 5% b) 3% conversion to open procedure, 1% repeat surgery, 1% recurrent herniations, 3% injured thecal sac, 13% transient dysaesthesia in the leg c) Transient dysaesthesia in 5%, 1 patient with further surgery Comments a) outcome measures not well described b) Loss to follow-up not described, no objective outcome measures c) Consecutive sample, radiologist blinded to study Guideline: Current evidence on the safety and efficacy of percutaneous endoscopic laser lumbar discectomy is inadequate in quantity and quality. Therefore this procedure should only be used with special arrangements for clinical governance, consent, and audit or research

GRADE assessment

Low

Did evidence justify recommendations

Yes

Summary of Findings: Guidelines Citation

Percutaneous intradiscal laser ablation in the lumbar spine. NICE IPG 357; 2010 and Overview document(213,227).

Guideline: Care pathway domain and topic

Treatment: Invasive procedures: Surgery

PICOT summary

Pop: Lumbar disc herniation Int: Percutaneous intradiscal laser ablation Comps: Microdiscectomy; automated percutaneous lumbar discectomy Out: Success rates (MacNab criteria); pain score

Guideline evidence:

Study designs: Case series; non-randomised comparative study Searching: Comprehensive search strategy Validity: Validity is commented on but no method stated.

Study design Searching and study

Chronic Pain Health Needs Assessment

219

selection Validity Guideline evidence: Outcomes: Benefits Harms Cost effectiveness

Laser disc decompression only: a) One case series (n=518) reported a success rate (based on McNab criteria) of 75%; absolute figures and follow-up not stated. b) One case series (n=576) reported that 61% of patients were satisfied with the outcome of the procedure; absolute figures and follow-up not stated. c) Case series (n=182), safety outcomes only reported d) Case-series (n=10), found no effect on low back pain or sciatica Safety a) 2 patients with aseptic discitis, 2 with septic discitis and 1 patient with a retro-oesophageal abscess b) 4 patients with aseptic discitis c) 4 patients with subchondral osteonecrosis d) leg sensory disturbance and/or muscle weakness in 3 patients Comments a) Results only for 350/518 patients (68%). Unclear when outcome was assessed. b) 67% at last follow-up c) Unclear completeness of follow-up; retrospective safety study d) Retrospective safety study, 100% follow-up Laser disc decompression versus microdiscectomy: Non-randomised comparative study (n=1000) reported similar rates of â&#x20AC;&#x2DC;excellent or goodâ&#x20AC;&#x2122; MacNab criteria scores in both groups. Safety Appear to be slightly more neurological symptoms, higher reoperation rates and other adverse events in the microdiscectomy group. Comments 100% follow-up. Unclear if retrospective. Laser disc decompression versus automated percutaneous lumbar discectomy Non-randomised comparative study (n=106). No significant differences between success rates (defined as excellent, good, passable or poor) between the groups. Safety 1 patient with infection of intervertebral disc (automated group). Comments No significant differences in study populations in the two groups. 100% follow-up, but timing unclear. Unclear if retrospective. Laser disc decompression using Nd:Yag laser (case series) Laser disc decompression using KTP laser versus automated percutaneous lumbar discectomy Non-randomised comparative study and case series (n=81).Relatively high failure rates (25% and 26%) in KTP laser and automated group meant that these techniques were abandoned early in the initial study (failure=daily back pain or daily use of analgesics). Safety 2 patients with aseptic discitis requiring hospitalisation in laser disc decompression using Nd:Yag group Comments 100% follow-up in both studies. No description of allocation of patients in comparative study Guideline: Current evidence on the safety and efficacy of percutaneous intradiscal laser ablation in the lumbar spine is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit. Patients selected for the procedure should be limited to those with severe pain refractory to conservative treatment, in whom imaging studies have shown bulging of an intact disc, and who do not have neurological deficit requiring surgical decompression.â&#x20AC;?

GRADE assessment

220

Low

Chronic Pain Health Needs Assessment

Did evidence justify recommendations

Yes

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Appendix 7

Link to main document Summary of findings: Multidisciplinary interventions

Summary of findings: systematic reviews Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Interventio n

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminat e or of limited effect Likely to be ineffective or potentially harmful

Scascighini (2008) (217) Multidisciplinary treatment for chronic pain: a systematic review of interventions and outcomes

27 RCTs

Without metaanalysis

Adults with chronic nonspecific musculoskeletal pain for example low back pain or back pain and fibromyalgia

Multidiscipl inary treatments

No treatment, standard medical treatment

Pain intensity, QoL, disability, coping, physical capacity, sick leave, drug intake, pain behaviour, use of health care professionals

Inclusion of many studies with diverse interventions meant that meta-analysis was not possible. The quality of included studies varied with only 6 studies being rated as high Evidence was strong for MDI being more effective than control group treatment in 15 studies, 5 studies showed no difference 3 studies that compared in-patient vs out-patient

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Multidisciplin ary pain management programmes offer safe and effective option for many chronic pain conditions Unclear as to which of the components of MDI are responsible for benefit

OCEBM level

Comments

Level 1

Multidisciplinary pain management programmes should be commissioned

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneit y, size of effect estimate and precision, generalizabili ty Not Cochrane review PRISMA: 9 items missing AMSTAR: Good

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Interventio n

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminat e or of limited effect Likely to be ineffective or potentially harmful

treatment found moderate evidence for better long term outcomes with intensive in-patient MDI

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Minimum standard for MDI comprises specific individual exercising, regular training in relaxation techniques, group therapy led by a clinical psychologist, patient education sessions, physiotherap y training sessions and clinician delivered

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneit y, size of effect estimate and precision, generalizabili ty

OCEBM level

Comments

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Interventio n

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminat e or of limited effect Likely to be ineffective or potentially harmful

Van Geen (2007) (218) The longterm effect of multidisciplinary back training: a systematic review

8 RCTs, included; total of 1958 participants

Without metaanalysis

Adults with back pain or chronic low back pain for at least 6 months

Multidiscipl inary back training

Standard treatment?

Work participation, experienced pain, functional status, QOL

One high quality study found effectiveness for low intensive multidisciplinary treatment compared to control, but not for intensive multidisciplinary treatment The other (low quality) studies found no effectiveness compared to controls 3 high quality RCTs found effectiveness for some outcome measures (but not all) for intensive compared to non-intensive programmes

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information about pain physiology 4/8 RCTs described as low quality

OCEBM level

Comments

Level 1

Multidisciplinar y back training has a positive impact on work participation of people with CLBP. The evidence for a positive effect on quality of life is limited. Intensity of treatment is not associated with treatment effectiveness

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneit y, size of effect estimate and precision, generalizabili ty

Cochrane review PRISMA:8 items missing AMSTAR: Good

Further research should be carried out with clearer definitions of

Citation Year Title, Authors

Number and type of primary studies

With or without metaanalysis

Population

Interventio n

Comparator

Outcome measures

Primary

Secondary

Findings

Included Excluded

Summary Finding

Quality

Effective, statistically significant

?Cochrane review

Indeterminat e or of limited effect Likely to be ineffective or potentially harmful

OCEBM level

Comments

PRISMA â&#x20AC;&#x201C; items not reported Critical Appraisal bias, heterogeneit y, size of effect estimate and precision, generalizabili ty chronic low back pain, intensity of treatment and multidisciplinar y back training

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Summary of Findings: Guidelines Citation

Chou R, Qaseem A, Snow V, Casey D, Cross JT, Shekelle P et al. Diagnosis and treatment of low back pain: a joint clinical practice guidelines from the American College of Physicians and the American Pain Society. Ann Int Med 2007; 147: 478-491.

Guideline: Care pathway domain and topic

Treatment: Multi-disciplinary pain programmes

PICOT summary

Pop: Adults with acute and chronic LBP not associated with major trauma Int: Multi disciplinary pain programmes Comp: Usual care, normal activities, exercise therapy, Out: Pain Study designs: Systematic reviews and RCTs Searching: Comprehensive search strategy. Studies were selected which matched the inclusion/exclusion criteria. Validity: Each paper was assessed for quality and critically appraised.

Guideline evidence: Study design Searching and study selection Validity Guideline evidence:

Interdisciplinary rehabilitation more effective than usual care for sub-acute back pain

Outcomes:

(a) Intensive (>100 hours), daily interdisciplinary rehabilitation moderately superior to non-interdisciplinary rehabilitation or usual care for short-and long-term functional status, and for pain outcomes (at 3-4 months in two trials). Long-term pain and return to work outcomes inconsistent.

Benefits Harms Cost effectiveness

(b) Less intensive interdisciplinary rehabilitation was no better than non-interdisciplinary rehabilitation or usual care Functional restoration with a CBT component was more effective than usual care, normal activities or standard exercise therapy for reducing time lost from work. Little evidence that functional restoration without a CBT component is effective.

GRADE assessment

High

Did evidence justify recommendations

Yes

Comments

Chronic pain health needs assessment 226

Summary of Findings: Guidelines Citation

Low back pain. Early management of persistent non-specific low back pain. CG 88; 2009(156)

Guideline: Care pathway domain and topic

Treatment: Multi-disciplinary pain programmes

PICOT summary

Pop: People aged 18 or older with symptoms of non-specific low back pain (LBP) which has not resolved within 6weeks of initial onset, consultation or exacerbation up to a period of 12 months. Int: Multi disciplinary pain management programmes (education, back school, exercises, plus a psychological component such as CBT, coping skills, problem solving training). Comp: Usual care in general practice, physiotherapy, spinal stabilisation. Out: Pain Study designs: RCTs Searching: Comprehensive search strategy. Studies were selected which matched the inclusion/exclusion criteria. Validity: Each paper was assessed for quality and critically appraised using the Instituteâ&#x20AC;&#x2122;s criteria for quality assessment.

Guideline evidence: Study design Searching and study selection Validity Guideline evidence: Outcomes: Benefits Harms Cost effectiveness

Low intensity programme Pain management programme (education, group exercises, CBT, 8 sessions of 90 minutes) versus individual physiotherapy (up to 12 sessions of 30 minutes) versus spinal stabilisation (specific muscle training and group exercise, up to 8 sessions of 90 minutes) All groups had improved on the Roland Morris Disability Questionnaire (RMDQ) at 18 months (not stated if significantly). No significant difference between groups at 18 months. Attrition rate between 17% and 32%. Comments Although also shown to be cost-effective, NICE did not make a recommendation for low intensity combined physical and psychological interventions due to the high attrition rate and the fact that there was no significant difference between groups. Low intensity programme (women only) Back school + usual care (a four day, five session programme, education, coping skills and exercises) versus usual care (medication with paracetamol, NSAIDs or chlordiazepoxide) Statistically significant difference on SF-36 in favour of back school, but results or p-values not presented. High intensity programme (at least one full day of five sessions a wk over at least 3 wks. Functional restoration programmes compared to other interventions/usual care (3 RCTs) or compared to physical training (1 RCT) Three of four RCTs found significant improvements in pain/disability for patients in the FR group compared to less intensive interventions. Follow-up was up to 5 years in one RCT (statistically significant difference in function but not pain at 5 years; difference in function and pain significant at 1 and 2 years). Format of interventions varied widely, but best evidence was considered to be that for programmes of >100 hours of exposure. High intensity programme Multidisciplinary programmes versus physiotherapy or no treatment. No significant differences in pain disability or depression (low risk of bias RCT); significantly better pain and function scores with the multidisciplinary approach in one study; one study did

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not conduct statistical analyses. High intensity programme Exercise and motivational programme versus exercise only. Pain and function statistically significantly improved in intervention group only at 12 months (pain only at 5 years)-NB unclear whether between group difference was statistically significant. High intensity programme Combination of physical training, graded activity and problem solving versus individual treatments No significant differences between groups at 12 months. Guideline: Consider referral for a combined physical and psychological treatment programme, comprising around 100 hours over a maximum of 8 weeks, for people who have received at least one less intensive treatment and have high disability and/or significant psychological distress. Combined physical and psychological treatment programmes should include a cognitive behavioural approach and exercise

228

GRADE assessment

High

Did evidence justify recommendations

Yes

Chronic Pain Health Needs Assessment

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