Botulinum for Chronic Exertional Compartment Syndrome

Stopped early · Phase 2/Phase 3

Conditions studied: Chronic Exertional Compartment Syndrome

In brief

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.

Key facts

Study ID

NCT03339921

Run by

375th Medical Group, Scott Air Force Base

People needed

3

Starts

2018-12-07

Expected to finish

2020-05-01

Last updated by the study team

2024-03-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 375th Medical Group — Scott Air Force Base, Illinois, United States

Full record on ClinicalTrials.gov

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