Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-24 @ 1:20 PM
NCT ID:
NCT01824095
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01824095
Study Brief:
Protocol Section:
NCT01824095