If the results are positive, Dr. Hawk said it may provide an additional tool for all practitioners who care for patients with ligamentous injuries. “Decreasing recovery time could contribute to improved quality of life for patients as well as reduced health care costs due to the high prevalence of sprains,” she said. “Additionally, the study will provide chiropractic interns, graduate students and practitioners with clinical research experience and introduce them to the use of nutritional supplements in the treatment of musculoskeletal injuries.” The team will conduct the study at three sites: Logan’s teaching clinics, where the
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researchers estimate four to 10 ankle sprains per month; Performance Health Care in St. Louis, with an estimated one to three ankle sprains per month; and Sport and Spine Rehab in the Washington, D.C. area, with an estimated seven to 21 ankle sprains per month. “I’m excited for the opportunity to conduct high-level clinical research that will benefit Standard Process, and am honored to be working with Dr. Hawk,” Dr. Enix said. “We are so fortunate to have her here at Logan. She provides a wealth of knowledge in chiropractic and patient-based research.”
Dr. Hawk hopes to enroll 90 patients in the study over the course of two years. “It’s exciting to be working on something highly relevant to the everyday chiropractic practice,” she said. “I look forward to seeing if the nutritional supplements can help speed up the healing process both initially and long term by preventing chronic occurrences and giving patients better stability over time.” During the next few months, Dr. Hawk and her team will seek approval from the Institutional Review Board, train personnel and set up an internal pilot test to ensure the procedures run smoothly. They plan to enroll patients in 2013.
S TANDARD P ROCESS R ESEARCH S TUDY
Research Study: Chiropractic Care and a Specific Regimen of Nutritional Supplementation for Patients with Acute Ankle Sprain: a Multi-site Randomized Controlled Trial Specific Aim 1: To compare, in terms of speed and the extent of improvement in physical function and pain, the short-term (6 week) effect of chiropractic care combined with a specific nutritional supplement regimen or placebo nutritional supplement to chiropractic care for patients with ankle sprains. Our hypothesis: Chiropractic care plus nutritional supplements designed to supply necessary nutrients for ligament healing will have improved outcomes in pain and disability, compared to chiropractic care plus placebo. We will use the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living Subscale (ADLS) to measure outcomes. Specific Aim 2: To compare, in terms of speed and the extent of improvement in physical function and pain, the long-term (6 month) effect of chiropractic care combined with a specific nutritional supplement regimen or placebo nutritional supplement to chiropractic care for patients with ankle sprains. Our hypothesis: Chiropractic care plus nutritional supplements designed to supply necessary nutrients for ligament healing will have improved outcomes in pain and disability, compared to chiropractic care plus placebo. We will use the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living Subscale (ADLS) to measure outcomes. Specific Aim 3: To explore any changes in the attitude, knowledge and behavior of chiropractic interns and practitioners regarding the role of nutrition in treating musculoskeletal injuries, pre- and post-intervention. We will also compare their
responses to those of a population of students and practitioners who did not participate in the project as a comparison group. Study Population: The study population will be comprised of patients presenting for usual and customary treatment at the participating sites. Criteria includes: acute ankle sprain within seven days prior to presenting for treatment and patients age 18 to 50. Exclusion criteria includes: diagnosis of grade III ankle sprain, fracture or dislocation; contradictions to chiropractic care; pregnancy; unwilling or unable to regularly take supplements; or litigation for a health-related claim. Interventions (chiropractic care): Chiropractic care will utilize a combination of the manual procedures and physical modalities commonly used in chiropractic practice, individualized according to the clinician’s judgment based on individual patient needs. Treatment frequency will also be individualized, following a general schedule of 1-3 times per week for four weeks or until pain-free weight bearing occurs. Interventions (nutritional supplements): Active treatment: Standard Process Ligaplex I (acute phase, four weeks) and Glucosamine Synergy (chronic phase, three months) used to support healing of ligamentous and other connective tissue, following the dosage recommended on the packages. Placebo supplements resembling the active supplements, but with inactive ingredients, will be given to the control group. Follow-up, compliance and attrition: The team will follow up with patients by phone to complete the outcome assessments if they are no longer under chiropractic care. To decrease attrition, patients will be given an incentive for completing the six-week (primary endpoint) and long-term (six month) follow-up assessments.
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