Botulinum for Chronic Exertional Compartment Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Botulinum Toxin to Fasciotomy in Treatment of Chronic Exertional Compartment Syndrome

Conditions
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Chronic Exertional Compartment Syndrome

Intervention / Treatment
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* Drug: Botulinum toxin injections for chronic compartment syndrome
* Procedure: surgical fasciotomy for chronic compartment syndrome


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum toxin injections<br>Botulinum toxin injections for chronic compartment syndrome | Drug: Botulinum toxin injections for chronic compartment syndrome<br>* Botulinum toxin will be injected in the upper and lower portion of the affected area with a syringe<br>|
| Active Comparator: surgical fasciotomy<br>surgical fasciotomy for chronic compartment syndrome | Procedure: surgical fasciotomy for chronic compartment syndrome<br>* linear incisions will be made into the affected compartment releasing the underlying fascial layer, reducing the pressure of the compartment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower Extremity Function index | Pain relief and increased function | 6 months |