NCT01824095

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

January 25, 2016

Status Verified

January 1, 2016

Enrollment Period

2.4 years

First QC Date

April 1, 2013

Last Update Submit

January 22, 2016

Conditions

Ankle Sprains

Outcome Measures

Primary Outcomes (1)

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

    baseline to 6 weeks

Secondary Outcomes (1)

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

    baseline to 6 months

Study Arms (2)

placebo

PLACEBO COMPARATOR

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

dietary supplement

EXPERIMENTAL

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

Interventions

Dietary supplementDIETARY_SUPPLEMENT
dietary supplementplacebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Sport and Spine Rehab

Columbia, Maryland, 21044, United States

Location

Sport and Spine Rehab

Ft. Washington, Maryland, 20744, United States

Location

Sport and Spine Rehab

Landover, Maryland, 20785, United States

Location

Sport and Spine Rehab

Rockville, Maryland, 20852, United States

Location

Brentwood Spine Clinic

Brentwood, Missouri, 63144, United States

Location

Logan University

Chesterfield, Missouri, 63017, United States

Location

Sport and Spine Rehab

Fairfax, Virginia, 22030, United States

Location

Sport and Spine Rehab

McLean, Virginia, 22101, United States

Location

Sport and Spine Rehab

Sterling, Virginia, 20164, United States

Location

MeSH Terms

Conditions

Ankle Injuries

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Cheryl K Hawk, DC, PhD

    Logan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2013

First Posted

April 4, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

January 25, 2016

Record last verified: 2016-01

Locations

US(9)