Botulinum for Chronic Exertional Compartment Syndrome (Botox)

375th Medical Group, Scott Air Force Base

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Chronic Exertional Compartment Syndrome

Treatments: Procedure: surgical fasciotomy for chronic compartment syndrome; Drug: Botulinum toxin injections for chronic compartment syndrome

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03339921

FWH20170037H

Details and patient eligibility

About

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.

Full 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 treatment interventions. The first arm will be patients receiving investigational botulinum toxin injections. The second arm will be patients who undergo the standard of care surgical fasciotomy. Both arms will be evaluated for pain relief with the universal pain scale and lower extremity functional index (LEFI) surveys at pre-treatment and again at one, three, and six months post-treatment. Clinical data that will be analyzed for research purposes in both groups include age, sex, height, weight, body mass index, time to diagnosis, minutes of exercise prior to onset of symptoms, minutes of rest before relief of symptoms, LEFI and pain on the Universal Pain Assessment Tool.

Enrollment: 3 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Botulinum toxin injections

Experimental group

Description:

Botulinum toxin injections for chronic compartment syndrome

Treatment:

Drug: Botulinum toxin injections for chronic compartment syndrome

surgical fasciotomy

Active Comparator group

Description:

surgical fasciotomy for chronic compartment syndrome

Treatment:

Procedure: surgical fasciotomy for chronic compartment syndrome