Botulinum for Chronic Exertional Compartment Syndrome

• Status: Terminated
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: 375th Medical Group, Scott Air Force Base
• Treatments: Botulinum Toxins

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