Status:
COMPLETED
Comparison of Non-Surgical Treatment Options for Chronic Exertional Compartment Syndrome (CECS)
Lead Sponsor:
Walter Reed National Military Medical Center
Collaborating Sponsors:
Uniformed Services University of the Health Sciences
Conditions:
Chronic Exertional Compartment Syndrome
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
Chronic Exertional Compartment Syndrome (CECS) in the lower leg is a debilitating condition in highly active individuals. Pain occurs in 1 or several leg compartments upon an exertional activity, typi...
Eligibility Criteria
Inclusion
- Active duty service
- Fluent in speaking and reading English
- Unable to run 2 miles without producing pain and/or symptoms
- Difficulty completing the running portion of their service-specific physical training due to pain and/or symptoms in their lower leg
- Meets clinical diagnostic criteria for CECS of the anterior or lateral compartment per clinical examination (palpation, intramuscular compartment pressure, lower leg MRI).
Exclusion
- Prior botulinum injection in the lower leg compartment of the affected limb
- Prior compartment release of affected lower leg
- Recent (within the last 6 months) lower limb injury that needed medical intervention
- Completed formal gait retraining within the last 6 months
- Allergic to botulinum toxin
- Pregnant or breastfeeding
- Medical examination that indicates a condition other than CECS
Key Trial Info
Start Date :
November 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2024
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04409600
Start Date
November 5 2020
End Date
December 6 2024
Last Update
March 10 2025
Active Locations (4)
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1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20307
2
Womack Army Medical Center
Fort Bragg, North Carolina, United States, 28310
3
Carl R. Darnell Army Medical Center
Killeen, Texas, United States, 76544
4
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, United States, 22060