Botulinum for Chronic Exertional Compartment Syndrome

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-07

Study Completion Date

2020-05-01

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.

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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.

Conditions

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Chronic Exertional Compartment Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Botulinum toxin injections

Botulinum toxin injections for chronic compartment syndrome

Group Type EXPERIMENTAL

Botulinum toxin injections for chronic compartment syndrome

Intervention Type DRUG

Botulinum toxin will be injected in the upper and lower portion of the affected area with a syringe

surgical fasciotomy

surgical fasciotomy for chronic compartment syndrome

Group Type ACTIVE_COMPARATOR

surgical fasciotomy for chronic compartment syndrome

Intervention Type PROCEDURE

linear incisions will be made into the affected compartment releasing the underlying fascial layer, reducing the pressure of the compartment

Interventions

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Botulinum toxin injections for chronic compartment syndrome

Botulinum toxin will be injected in the upper and lower portion of the affected area with a syringe

Intervention Type DRUG

surgical fasciotomy for chronic compartment syndrome

linear incisions will be made into the affected compartment releasing the underlying fascial layer, reducing the pressure of the compartment

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No