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

Ankle Sprains Clinical Trial

— ASP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01824095
• Other study ID #: Standard Process - 2013
• Status: Terminated
• Phase: Phase 3
• First received: April 1, 2013
• Last updated: January 22, 2016
• Start date: January 2013
• Est. completion date: June 2015

Study information

• Verified date: January 2016
• Source: Logan University, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 73
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprains

Intervention

Dietary Supplement:
• Dietary supplement

Locations

Country	Name	City	State
United States	Brentwood Spine Clinic	Brentwood	Missouri
United States	Logan University	Chesterfield	Missouri
United States	Sport and Spine Rehab	Columbia	Maryland
United States	Sport and Spine Rehab	Fairfax	Virginia
United States	Sport and Spine Rehab	Fort Washington	Maryland
United States	Sport and Spine Rehab	Landover	Maryland
United States	Sport and Spine Rehab	McLean	Virginia
United States	Sport and Spine Rehab	Rockville	Maryland
United States	Sport and Spine Rehab	Sterling	Virginia

Sponsors (4)

Lead Sponsor	Collaborator
Logan University, Inc.	Brentwood Spine Clinic, Brentwood, MO, USA, Parker University, Sport and Spine Rehab Clinical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Foot and Ankle Ability Measure (FAAM) Activities of Daily Living Subscale (ADLS)		baseline to 6 weeks	No
Secondary	Foot and Ankle Ability Measure (FAAM) Activities of Daily Living Subscale (ADLS)		baseline to 6 months	No