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

Primary Purpose

Ankle Sprains

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dietary supplement
Sponsored by
Logan University, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprains

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sport and Spine Rehab
  • Sport and Spine Rehab
  • Sport and Spine Rehab
  • Sport and Spine Rehab
  • Brentwood Spine Clinic
  • Logan University
  • Sport and Spine Rehab
  • Sport and Spine Rehab
  • Sport and Spine Rehab

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo

dietary supplement

Arm Description

Acute phase (1st treatment through Week 4): Placebo. 2 capsules 3 x day. Chronic phase (Weeks 5-16): Placebo. 1 capsule 3 x day.

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.

Outcomes

Primary Outcome Measures

Foot and Ankle Ability Measure (FAAM) Activities of Daily Living Subscale (ADLS)

Secondary Outcome Measures

Foot and Ankle Ability Measure (FAAM) Activities of Daily Living Subscale (ADLS)

Full Information

First Posted
April 1, 2013
Last Updated
January 22, 2016
Sponsor
Logan University, Inc.
Collaborators
Sport and Spine Rehab Clinical Research Foundation, Parker University, Brentwood Spine Clinic, Brentwood, MO, USA
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1. Study Identification

Unique Protocol Identification Number
NCT01824095
Brief Title
Chiropractic Care and a Specific Regimen of Nutritional Supplementation for Patients With Acute Ankle Sprain
Acronym
ASP
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit enough subjects to attain the minimum sample size.
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Logan University, Inc.
Collaborators
Sport and Spine Rehab Clinical Research Foundation, Parker University, Brentwood Spine Clinic, Brentwood, MO, USA

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprains

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Acute phase (1st treatment through Week 4): Placebo. 2 capsules 3 x day. Chronic phase (Weeks 5-16): Placebo. 1 capsule 3 x day.
Arm Title
dietary supplement
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary supplement
Primary Outcome Measure Information:
Title
Foot and Ankle Ability Measure (FAAM) Activities of Daily Living Subscale (ADLS)
Time Frame
baseline to 6 weeks
Secondary Outcome Measure Information:
Title
Foot and Ankle Ability Measure (FAAM) Activities of Daily Living Subscale (ADLS)
Time Frame
baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl K Hawk, DC, PhD
Organizational Affiliation
Logan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sport and Spine Rehab
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Sport and Spine Rehab
City
Fort Washington
State/Province
Maryland
ZIP/Postal Code
20744
Country
United States
Facility Name
Sport and Spine Rehab
City
Landover
State/Province
Maryland
ZIP/Postal Code
20785
Country
United States
Facility Name
Sport and Spine Rehab
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Brentwood Spine Clinic
City
Brentwood
State/Province
Missouri
ZIP/Postal Code
63144
Country
United States
Facility Name
Logan University
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Sport and Spine Rehab
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States
Facility Name
Sport and Spine Rehab
City
McLean
State/Province
Virginia
ZIP/Postal Code
22101
Country
United States
Facility Name
Sport and Spine Rehab
City
Sterling
State/Province
Virginia
ZIP/Postal Code
20164
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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