Clinical trial NCT01824095: Chiropractic Care and a Specific Regimen of Nutritional Supplementation for Patients With Acute Ankle Sprain
Official title: Chiropractic Care and a Specific Regimen of Nutritional Supplementation for Patients With Acute Ankle Sprain: a Multisite Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Ankle Sprains
Lead sponsor: Logan University, Inc.
Sponsor class: OTHER
Collaborators: name: Sport and Spine Rehab Clinical Research Foundation
name: Parker University
name: Brentwood Spine Clinic, Brentwood, MO, USA
First posted: 2013-04-04
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 supplement regimen to chiropractic care with a placebo supplement for patients with ankle sprains, in terms of improvement in physical function and pain.

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 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.

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.

Primary outcomes:
measure: Foot and Ankle Ability Measure (FAAM) Activities of Daily Living Subscale (ADLS)
timeFrame: baseline to 6 weeks
Secondary outcomes:
measure: Foot and Ankle Ability Measure (FAAM) Activities of Daily Living Subscale (ADLS)
timeFrame: baseline to 6 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Sport and Spine Rehab
state: Maryland
city: Fort Washington
country: United States
facility: Sport and Spine Rehab
state: Maryland
city: Landover
country: United States
facility: Sport and Spine Rehab
state: Maryland
city: Rockville
country: United States
facility: Sport and Spine Rehab
state: Maryland
city: Brentwood
country: United States
facility: Brentwood Spine Clinic
state: Missouri
city: Chesterfield
country: United States
facility: Logan University
state: Missouri
city: Fairfax
country: United States
facility: Sport and Spine Rehab
state: Virginia
city: McLean
country: United States
facility: Sport and Spine Rehab
state: Virginia
city: Sterling
country: United States
facility: Sport and Spine Rehab
state: Virginia
Study officials:
affiliation: Logan University
name: Cheryl K Hawk, DC, PhD
role: PRINCIPAL_INVESTIGATOR
References: