Chiropractic Care and a Specific Regimen of Nutritional Supplementation for Patients With Acute Ankle Sprain (ASP)
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| ClinicalTrials.gov Identifier: NCT01824095 |
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Recruitment Status :
Terminated
(Unable to recruit enough subjects to attain the minimum sample size.)
First Posted : April 4, 2013
Last Update Posted : January 25, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ankle Sprains | Dietary Supplement: Dietary supplement | Phase 3 |
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 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 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Dietary Supplement: Dietary supplement |
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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 |
- Foot and Ankle Ability Measure (FAAM) Activities of Daily Living Subscale (ADLS) [ Time Frame: baseline to 6 weeks ]
- Foot and Ankle Ability Measure (FAAM) Activities of Daily Living Subscale (ADLS) [ Time Frame: baseline to 6 months ]
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824095
| 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 | |
| Principal Investigator: | Cheryl K Hawk, DC, PhD | Logan University |
| Responsible Party: | Logan University, Inc. |
| ClinicalTrials.gov Identifier: | NCT01824095 History of Changes |
| Other Study ID Numbers: |
Standard Process - 2013 |
| First Posted: | April 4, 2013 Key Record Dates |
| Last Update Posted: | January 25, 2016 |
| Last Verified: | January 2016 |
Additional relevant MeSH terms:
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Sprains and Strains Ankle Injuries Wounds and Injuries Leg Injuries |