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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Ankle Sprains	Dietary Supplement: Dietary supplement	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	73 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Chiropractic Care and a Specific Regimen of Nutritional Supplementation for Patients With Acute Ankle Sprain: a Multisite Randomized Controlled Trial
Study Start Date :	January 2013
Actual Primary Completion Date :	June 2015
Actual Study Completion Date :	June 2015

Arms and Interventions

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Arm	Intervention/treatment
Placebo Comparator: placebo; Acute phase (1st treatment through Week 4): Placebo. 2 capsules 3 x day. Chronic phase (Weeks 5-16): Placebo. 1 capsule 3 x day.	Dietary Supplement: Dietary supplement
Experimental: dietary supplement; Acute phase (1st treatment through Week 4): Ligaplex 1. Ligaplex 1 supplies nutrients to support connective tissue and reduce inflammation. The protocol is commonly used in chiropractic practice and suggested by Standard Process: 2 capsules 3 x day. Chronic phase (Weeks 5-16): Glucosamine Synergy. This supplement maintains connective tissue and joint health. The protocol is commonly used in chiropractic practice and suggested by Standard Process: 1 capsule 3 x day.	Dietary Supplement: Dietary supplement

Outcome Measures

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Primary Outcome Measures :

1. Foot and Ankle Ability Measure (FAAM) Activities of Daily Living Subscale (ADLS) [ Time Frame: baseline to 6 weeks ]

Secondary Outcome Measures :

1. Foot and Ankle Ability Measure (FAAM) Activities of Daily Living Subscale (ADLS) [ Time Frame: baseline to 6 months ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Maryland
Sport and Spine Rehab
Columbia, Maryland, United States, 21044
Sport and Spine Rehab
Fort Washington, Maryland, United States, 20744
Sport and Spine Rehab
Landover, Maryland, United States, 20785
Sport and Spine Rehab
Rockville, Maryland, United States, 20852
United States, Missouri
Brentwood Spine Clinic
Brentwood, Missouri, United States, 63144
Logan University
Chesterfield, Missouri, United States, 63017
United States, Virginia
Sport and Spine Rehab
Fairfax, Virginia, United States, 22030
Sport and Spine Rehab
McLean, Virginia, United States, 22101
Sport and Spine Rehab
Sterling, Virginia, United States, 20164

Sponsors and Collaborators

Logan University, Inc.

Sport and Spine Rehab Clinical Research Foundation

Parker University

Brentwood Spine Clinic, Brentwood, MO, USA

Investigators

Principal Investigator:	Cheryl K Hawk, DC, PhD	Logan University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Logan University, Inc.
ClinicalTrials.gov Identifier:	NCT01824095 History of Changes
Other Study ID Numbers:	Standard Process - 2013
First Posted:	April 4, 2013
Last Update Posted:	January 25, 2016
Last Verified:	January 2016

Additional relevant MeSH terms:

Sprains and Strains; Ankle Injuries; Wounds and Injuries; Leg Injuries