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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Logan University, Inc.
Sponsor:
Collaborators:
Sport and Spine Rehab Clinical Research Foundation
Parker University
Brentwood Spine Clinic, Brentwood, MO, USA
Information provided by (Responsible Party):
Logan University, Inc.
ClinicalTrials.gov Identifier:
NCT01824095
First received: April 1, 2013
Last updated: NA
Last verified: April 2013
History: No changes posted
  Purpose

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 Intervention Phase
Ankle Sprains
Dietary Supplement: Dietary supplement
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Logan University, Inc.:

Primary Outcome Measures:
  • Foot and Ankle Ability Measure (FAAM) Activities of Daily Living Subscale (ADLS) [ Time Frame: baseline to 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Foot and Ankle Ability Measure (FAAM) Activities of Daily Living Subscale (ADLS) [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
Experimental: dietary supplement Dietary Supplement: Dietary supplement

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01824095

Contacts
Contact: Cheryl K Hawk, DC, PhD 515-779-6777 cheryl.hawk@logan.edu
Contact: Michelle L Anderson 636-230-1946 michelle.anderson@logan.edu

Locations
United States, Maryland
Sport and Spine Rehab Recruiting
Columbia, Maryland, United States, 21044
Contact: Emily Gardner    410-964-0837    egardner@ssrehab.com   
Contact: Jena L Etnoyer, MEd    301-251-2777 ext 838    jetnoyer@ssrehab.com   
Sub-Investigator: Christopher Steacy, DC         
Sport and Spine Rehab Recruiting
Fort Washington, Maryland, United States, 20744
Contact: Shellene Dickerson    301-203-6734    sdickerson@ssrehab.com   
Contact: Jena L Etnoyer, MEd    301-251-2777 ext 838    jetnoyer@ssrehab.com   
Sub-Investigator: Everett Scott, DC         
Sport and Spine Rehab Recruiting
Landover, Maryland, United States, 20785
Contact: Udim Isang    301-577-1115    uisang@ssrehab.com   
Contact: Jena L Etnoyer, MEd    301-251-2777 ext 838    jetnoyer@ssrehab.com   
Sub-Investigator: Allen Huffman, DC         
Sport and Spine Rehab Recruiting
Rockville, Maryland, United States, 20852
Contact: Henry Ventura    301-251-2777    hventura@ssrehab.com   
Contact: Jena L Etnoyer, MEd    301-251-2777 ext 838    jetnoyer@ssrehab.com   
Sub-Investigator: Jennifer Davis, DC         
United States, Missouri
Brentwood Spine Clinic Recruiting
Brentwood, Missouri, United States, 63144
Contact: Clint Daniels, DC    314-968-7540    cdaniels06@gmail.com   
Sub-Investigator: Clint Daniels, DC         
Logan University Recruiting
Chesterfield, Missouri, United States, 63017
Principal Investigator: Cheryl K Hawk, DC, PhD         
Sub-Investigator: Weiwen Chai, PhD         
Sub-Investigator: Dennis Enix, DC         
Sub-Investigator: Laney Nelson, DC         
United States, Virginia
Sport and Spine Rehab Recruiting
Fairfax, Virginia, United States, 22030
Contact: Kristen Bloss    703-890-2222    kbloss@ssrehab.com   
Contact: Jena L Etnoyer, MEd    301-251-2777 ext 838    jetnoyer@ssrehab.com   
Sub-Investigator: Martin Donnelly, DC         
Sport and Spine Rehab Recruiting
McLean, Virginia, United States, 22101
Contact: Maria Warrenfeltz    703-448-5799    mwarrenfeltz@ssrehab.com   
Contact: Jena L Etnoyer, MEd    301-251-2777 ext 838    jetnoyer@ssrehab.com   
Sub-Investigator: Riccardo Tersigni, DC         
Sport and Spine Rehab Recruiting
Sterling, Virginia, United States, 20164
Contact: Jen O'Connor    571-323-2120    joconnor@ssrehab.com   
Contact: Jena L Etnoyer, MEd    301-251-2777 ext 838    jetnoyer@ssrehab.com   
Sub-Investigator: Matthew Clay, DC         
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

No publications provided

Responsible Party: Logan University, Inc.
ClinicalTrials.gov Identifier: NCT01824095     History of Changes
Other Study ID Numbers: Standard Process - 2013
Study First Received: April 1, 2013
Last Updated: April 1, 2013
Health Authority: United States: Institutional Review Board
United States: Data Safety and Monitoring Board

Additional relevant MeSH terms:
Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on July 24, 2014