Botulinum for Chronic Exertional Compartment Syndrome (Botox)
Primary Purpose
Chronic Exertional Compartment Syndrome
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Botulinum toxin injections for chronic compartment syndrome
surgical fasciotomy for chronic compartment syndrome
Sponsored by

About this trial
This is an interventional treatment trial for Chronic Exertional Compartment Syndrome
Eligibility Criteria
Inclusion Criteria:
- Adult ages 18-65
- Active duty military
- Unable to run 1.5 miles without producing symptoms, including aching, burning, numbness, tingling, or weakness in the affected limb
- Failed conservative treatment over a period of 2 months, including trial of rest, NSAIDs, icing, and stretching routine
- Meets standard of care clinical diagnostic intramuscular compartment pressure criteria for CECS, based on standardized IMP needle testing. See below for testing protocol and criteria.
Exclusion Criteria:
- Prior Botulinum toxin injections into the affected limb
- Prior compartment release of the affected limb
- Pregnant or becomes pregnant during the study
- Standard of care clinical exams indicating other more likely causes of leg pain
Sites / Locations
- 375th Medical Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Botulinum toxin injections
surgical fasciotomy
Arm Description
Botulinum toxin injections for chronic compartment syndrome
surgical fasciotomy for chronic compartment syndrome
Outcomes
Primary Outcome Measures
Lower Extremity Function index
Pain relief and increased function
Secondary Outcome Measures
Full Information
NCT ID
NCT03339921
First Posted
November 8, 2017
Last Updated
June 29, 2020
Sponsor
375th Medical Group, Scott Air Force Base
1. Study Identification
Unique Protocol Identification Number
NCT03339921
Brief Title
Botulinum for Chronic Exertional Compartment Syndrome
Acronym
Botox
Official Title
Comparison of Botulinum Toxin to Fasciotomy in Treatment of Chronic Exertional Compartment Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
This study is being closed because it is unworkable.
Study Start Date
December 7, 2018 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
375th Medical Group, Scott Air Force Base
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
We will investigate the feasibility of a simple outpatient one time injection regimen for the treatment of Chronic Exertional Compartment Syndrome (CECS). We think botulinum toxin injections will be a potentially cost-effective, low-risk alternative to surgery in reducing pain and returning patients to full activity.
Detailed Description
The study will be a prospective cohort pilot study designed to compare Active Duty patients, 18 years of age or older, with Chronic Exertional Compartment Syndrome (CECS) undergoing two different treatment interventions. The first arm will be patients receiving investigational botulinum toxin injections. The second arm will be patients who undergo the standard of care surgical fasciotomy. Both arms will be evaluated for pain relief with the universal pain scale and lower extremity functional index (LEFI) surveys at pre-treatment and again at one, three, and six months post-treatment. Clinical data that will be analyzed for research purposes in both groups include age, sex, height, weight, body mass index, time to diagnosis, minutes of exercise prior to onset of symptoms, minutes of rest before relief of symptoms, LEFI and pain on the Universal Pain Assessment Tool.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Exertional Compartment Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Botulinum toxin injections
Arm Type
Experimental
Arm Description
Botulinum toxin injections for chronic compartment syndrome
Arm Title
surgical fasciotomy
Arm Type
Active Comparator
Arm Description
surgical fasciotomy for chronic compartment syndrome
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin injections for chronic compartment syndrome
Intervention Description
Botulinum toxin will be injected in the upper and lower portion of the affected area with a syringe
Intervention Type
Procedure
Intervention Name(s)
surgical fasciotomy for chronic compartment syndrome
Intervention Description
linear incisions will be made into the affected compartment releasing the underlying fascial layer, reducing the pressure of the compartment
Primary Outcome Measure Information:
Title
Lower Extremity Function index
Description
Pain relief and increased function
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult ages 18-65
Active duty military
Unable to run 1.5 miles without producing symptoms, including aching, burning, numbness, tingling, or weakness in the affected limb
Failed conservative treatment over a period of 2 months, including trial of rest, NSAIDs, icing, and stretching routine
Meets standard of care clinical diagnostic intramuscular compartment pressure criteria for CECS, based on standardized IMP needle testing. See below for testing protocol and criteria.
Exclusion Criteria:
Prior Botulinum toxin injections into the affected limb
Prior compartment release of the affected limb
Pregnant or becomes pregnant during the study
Standard of care clinical exams indicating other more likely causes of leg pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett Boyce, MD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
375th Medical Group
City
Scott Air Force Base
State/Province
Illinois
ZIP/Postal Code
62225
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Botulinum for Chronic Exertional Compartment Syndrome
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