Status:
TERMINATED
Chiropractic Care and a Specific Regimen of Nutritional Supplementation for Patients With Acute Ankle Sprain
Lead Sponsor:
Logan University, Inc.
Collaborating Sponsors:
Sport and Spine Rehab Clinical Research Foundation
Parker University
Conditions:
Ankle Sprains
Eligibility:
All Genders
18-50 years
Phase:
PHASE3
Brief Summary
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 supplemen...
Detailed Description
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 pa...
Eligibility Criteria
Inclusion
- Acute ankle sprain, defined as ankle sprain within the past 7 days, by patient report. Treating clinician will verify diagnosis via clinical examination.
- Ages 18-50; ankle sprains are more common in this age group.
Exclusion
- Diagnosis of grade III ankle sprain, fracture or dislocation; fracture will be diagnosed using the Ottawa ankle rules11,12
- Contraindications to chiropractic care, such as fracture or other abnormalities found by history, examination, or x-rays, as determined by the treating or supervising clinician.
- Pregnancy: although it is unlikely that the nutritional supplements would have adverse effects on the fetus, we are excluding pregnant women as a safeguard.
- Unwilling or unable to regularly take the supplements (e.g., vegetarians; known sensitivity by self-report; patients will be shown the ingredient list prior to signing the informed consent).
- Litigation for a health-related claim (in process or pending).
- History of ankle surgery or presence of ankle hardware (pins, screws, etc.), by patient report.
- History of diabetic or other peripheral neuropathy, by patient report.
- Current use of prescription or nonprescription medications that may interact with experimental or placebo supplements, by patient report.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01824095
Start Date
January 1 2013
End Date
June 1 2015
Last Update
January 25 2016
Active Locations (9)
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1
Sport and Spine Rehab
Columbia, Maryland, United States, 21044
2
Sport and Spine Rehab
Ft. Washington, Maryland, United States, 20744
3
Sport and Spine Rehab
Landover, Maryland, United States, 20785
4
Sport and Spine Rehab
Rockville, Maryland, United States, 20852