A Phase 3 interventional study of Dietary supplement in Ankle Sprains, sponsored by Logan University, Inc.. Terminated at 9 sites in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2016-01-25.
Sponsored by Logan University, Inc. · Phase 3, Interventional, and Treatment
The purpose of this multisite randomized controlled trial (RCT) is to compare the short-term (6 week) and long-term (6 month) effect of chiropractic care combined with a specific nutritional supplement regimen to chiropractic care with a placebo supplement for patients with ankle sprains, in terms of improvement in physical function and pain.
Specific Aim 1: to compare the short-term (6 week) effect of chiropractic care combined with a specific nutritional supplement regimen to chiropractic care with a placebo nutritional supplement for patients with ankle sprains, in terms of speed and amount of improvement in physical function and pain. Our hypothesis is that 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 Activities of Daily Living Subscale (FAAM ADLS) to measure outcomes.
Specific aim 2: to compare the long-term (6 month) effect of chiropractic care combined with a specific nutritional supplement regimen to chiropractic care with a placebo nutritional supplement for patients with ankle sprains, in terms of speed and amount of improvement in physical function and pain. Our hypothesis is that chiropractic care plus nutritional supplements designed to supply necessary nutrients for ligament healing will have improved outcomes as measured by the FAAM ADLS, compared to chiropractic care plus placebo.
Specific aim 3: to explore any changes in the attitude, knowledge and behavior of chiropractic interns and practitioners of 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.
217 studies on the registry are indexed under Sprains and Strains; 44 are open to participants now.
This study's enrollment of 73 is above the median of 60 across 166 interventional studies indexed under Sprains and Strains.
Browse Sprains and Strains studies →This is the only study on the registry with Logan University, Inc. as lead sponsor.
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Exclusion Criteria:
Acute phase (1st treatment through Week 4): Placebo. 2 capsules 3 x day. Chronic phase (Weeks 5-16): Placebo. 1 capsule 3 x day.
Dietary Supplement: Dietary supplement
Acute phase (1st treatment through Week 4): Ligaplex 1. Ligaplex 1 supplies nutrients to support connective tissue and reduce inflammation. The protocol is commonly used in chiropractic practice and suggested by Standard Process: 2 capsules 3 x day. Chronic phase (Weeks 5-16): Glucosamine Synergy. This supplement maintains connective tissue and joint health. The protocol is commonly used in chiropractic practice and suggested by Standard Process: 1 capsule 3 x day.
Dietary Supplement: Dietary supplement
Foot and Ankle Ability Measure (FAAM) Activities of Daily Living Subscale (ADLS)
Time frame: baseline to 6 weeks
Foot and Ankle Ability Measure (FAAM) Activities of Daily Living Subscale (ADLS)
Time frame: baseline to 6 months
This study is terminated, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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