Status:
TERMINATED
Botulinum for Chronic Exertional Compartment Syndrome
Lead Sponsor:
375th Medical Group, Scott Air Force Base
Conditions:
Chronic Exertional Compartment Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
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...
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 trea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2020
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03339921
Start Date
December 7 2018
End Date
May 1 2020
Last Update
March 5 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
375th Medical Group
Scott Air Force Base, Illinois, United States, 62225