Logan Receives $700,000 Standard Process® Inc. Grant to Lead Novel Nutrition Study
Research will explore the effect of nutritional supplements and chiropractic on acute ankle sprains.
Standard Process® Inc. has awarded
Logan College of Chiropractic/University Programs a $700,000 grant to study the relationship between nutritional supplements and chiropractic intervention on patients with acute ankle sprain. Logan was selected among 13 other
chiropractic college applicants vying for the research grant—the first of its kind awarded by the Wisconsin-based manufacturer of nutritional whole food supplements.
“It was highly competitive due to the fact that there are so few sources of funding for clinical research,” said Logan’s Director of Clinical Research Cheryl Hawk, DC, PhD, who submitted the application and proposal. “This grant is a real testament to our commitment to nutrition and the expertise of our team.”
Entitled “Chiropractic Care and a Specific Regimen of Nutritional Supplementation for Patients with Acute Ankle Sprain: a Multi-site Randomized Controlled Trial,” the study will focus on chiropractic intervention for individuals with acute ankle sprain offered in combination with Standard Process’ Ligaplex, a nutritional supplement that provides acute ligament and muscle support.
Dr. Hawk’s extensive research experience—working as a principal investigator for 35 years in chiropractic, spending 26 years in clinical practice and leading more than 25 clinical studies—places her at a distinct advantage for leading this study.
“In practice we saw plenty of patients with ligament problems, and Ligaplex sped up healing for those with chronic pain,” she said. “It’s widely used and we know it’s safe, but until now, we have only known it from our own experience.”
To carry out the two-year study, Dr. Hawk has assembled a diverse research team offering extensive backgrounds in nutrition, sports and rehabilitation, and clinical practice. They include:
-
Dennis Enix, DC, MBA, Associate Professor of Research
- Weiwen Chai, MS, PhD, Director of Logan’s Master of Science Degree Program in Nutrition and Human Performance
- Laney Nelson, DC, DACBSP, Director of Logan’s BIOFREEZE® Sports & Rehabilitation Center
- Clint Daniels, DC, MS, Co-owner of Performance Health Care LLC in St. Louis, Mo.
- Harrison Ndetan, MSc, MPH, DrPH, Associate Professor of Research at Parker University
- Jay Greenstein, DC, CCSP, Director of Sport and Spine Rehab Clinic in the Washington, D.C. area
- Michelle Anderson, Program Coordinator for Research Networks at Logan
“Our team has the motivation and expertise to successfully conduct this study, which has important implications for musculoskeletal practitioners,” said Dr. Hawk. “Because of the study’s design, which utilizes both teaching clinics and established private practices that all employ chiropractic care, its results will offer relevant and useful information for real-life practitioners.”
Dr. Chai said she was thrilled to hear that Logan received the grant, especially since the research project will involve graduate students from the Master’s Program in Nutrition and Human Performance. “This provides the perfect opportunity for students who are interested in evidence-based, well-designed clinical research related to nutrition and chiropractic treatment,” she said. “I look forward to working on the nutrition component of the project.”
Initially, Drs. Hawk and Enix discussed proposing a loose design study, which would include any kind of sprain or strain; however,
it was Dr. Enix who suggested further narrowing the research to focus solely on ankle sprains. “I thought, ‘what do chiropractors see in patients, more than anything?’” he said. “Ankle sprains are among the most common conditions treated by DCs. They are easy to diagnose but often result in recurring injuries.”
According to Drs. Enix and Hawk, ankle sprains result in more lost work and school days than any other health condition. While manipulative therapy along with standard remedies—such as rest, ice and elevation—prove effective in treating the majority of sprains, some people face persistent pain and instability. Additionally, virtually no research exists detailing the effect a nutritional regimen, combined with manipulative therapy and exercise, could have on patients suffering from ankle sprains.
“Looking at the design of the study, sports injury and nutritional supplement blend perfectly,” Dr. Enix said. “We will not just be looking at this as a single treatment, rather we’ll be using it to advance the real-world application of chiropractic care.”
In this study, the research team will use both Ligaplex and a placebo, manufactured by Standard Process to look exactly like Ligaplex, in a multi-site, triple-blinded, randomized controlled trial—meaning that the clinicians, patients and the data analyst will
not know the patients’ treatment group status.
Dr. Hawk said often times with a medication, patients can figure out if they are a part of the active group or control group; but with a nutritional supplement, it will be much harder for them to know if they’re receiving the placebo. “While I’ve done multi-site research studies in the past, I’ve never tested supplements, let alone used a placebo; I’ve always tested manual procedures,” Dr. Hawk said. “But here, we’re not testing chiropractic; we’re assuming that works. The goal of the study is to test the efficacy of a specific nutritional supplement regimen versus the placebo combined with usual and customary chiropractic care for improving both short- and long-term physical function in ankle sprain patients.”
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 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.