Chiropractic Care and a Specific Regimen of Nutritional Supplementation for Patients With Acute Ankle Sprain

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Ankle Sprains

In brief

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.

Key facts

Study ID

NCT01824095

Run by

Logan University, Inc.

People needed

73

Starts

2013-01-01

Expected to finish

2015-06-01

Last updated by the study team

2016-01-25

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sport and Spine Rehab — Columbia, Maryland, United States
• Sport and Spine Rehab — Ft. Washington, Maryland, United States
• Sport and Spine Rehab — Landover, Maryland, United States
• Sport and Spine Rehab — Rockville, Maryland, United States
• Brentwood Spine Clinic — Brentwood, Missouri, United States
• Logan University — Chesterfield, Missouri, United States
• Sport and Spine Rehab — Fairfax, Virginia, United States
• Sport and Spine Rehab — McLean, Virginia, United States
• Sport and Spine Rehab — Sterling, Virginia, United States

Full record on ClinicalTrials.gov

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