TerminatedPhase 2/3

Botulinum for Chronic Exertional Compartment Syndrome

Stopped: This study is being closed because it is unworkable.

United States3 participantsStarted 2018-12-07

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Lower Extremity Functional Index

Timeframe: 6 months

Trial details

NCT IDNCT03339921

Sponsor375th Medical Group, Scott Air Force Base

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2020-05-01

Results submitted2024-01-17

View on ClinicalTrials.gov More Chronic Exertional Compartment Syndrome trials