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



Status:Terminated
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 50
Updated:4/21/2016
Start Date:January 2013
End Date:June 2015

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Chiropractic Care and a Specific Regimen of Nutritional Supplementation for Patients With Acute Ankle Sprain: a Multisite Randomized Controlled Trial

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.

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.
We found this trial at
9
sites
Chesterfield, Missouri 63017
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Chesterfield, MO
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Brentwood, Missouri 63144
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Brentwood, MO
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Columbia, Maryland 21044
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Columbia, MD
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Fairfax, Virginia 22030
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Fairfax, VA
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Fort Washington, Maryland 20744
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Fort Washington, MD
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Landover, Maryland 20785
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Landover, MD
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McLean, Virginia 22101
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McLean, VA
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Rockville, Maryland 20852
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Rockville, MD
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Sterling, Virginia 20164
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Sterling, VA
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