Comparison of Non-Surgical Treatment Options for Chronic Exertional Compartment Syndrome (CECS)

Walter Reed National Military Medical Center

Status and phase: Completed; Phase 2

Conditions: Chronic Exertional Compartment Syndrome

Treatments: Drug: Botulinum Toxin Injection; Behavioral: Supervised Gait Retraining; Drug: Saline Injection; Behavioral: Home Based Gait Retraining

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04409600

WRNMMC-2019-0266

Details and patient eligibility

About

Chronic Exertional Compartment Syndrome (CECS) in the lower leg is a debilitating condition in highly active individuals. Pain occurs in 1 or several leg compartments upon an exertional activity, typically running, that quickly dissipates once the activity stopped. Surgical fasciotomy is the standard for treating lower leg CECS, but success is variable. Complications may occur post-surgery and there is a potential for a repeat procedure. Recovery times post-surgery also vary greatly. Conservative treatments, such as gait retraining and botulinum toxin injections, are emerging as non-surgical options for the treatment of CECS with success through published case reports and case series. This study aims to evaluate the use of these non-surgical treatment options for CECS in the anterior and lateral leg compartments with a follow up for at least 2 years across multiple study sites.

Enrollment: 46 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Active duty service
• Fluent in speaking and reading English
• Unable to run 2 miles without producing pain and/or symptoms
• Difficulty completing the running portion of their service-specific physical training due to pain and/or symptoms in their lower leg
• Meets clinical diagnostic criteria for CECS of the anterior or lateral compartment per clinical examination (palpation, intramuscular compartment pressure, lower leg MRI).

Exclusion criteria

• Prior botulinum injection in the lower leg compartment of the affected limb
• Prior compartment release of affected lower leg
• Recent (within the last 6 months) lower limb injury that needed medical intervention
• Completed formal gait retraining within the last 6 months
• Allergic to botulinum toxin
• Pregnant or breastfeeding
• Medical examination that indicates a condition other than CECS

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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46 participants in 4 patient groups

Home Based Gait Retraining + Saline Injection

Active Comparator group

Treatment:

Behavioral: Home Based Gait Retraining

Drug: Saline Injection

Home Based Gait Retraining + Botulinum Toxin Injection

Experimental group

Treatment:

Behavioral: Home Based Gait Retraining

Drug: Botulinum Toxin Injection

Supervised Gait Retraining + Saline Injection

Active Comparator group

Treatment:

Drug: Saline Injection

Behavioral: Supervised Gait Retraining

Supervised Gait Retraining + Botulinum Toxin Injection

Experimental group

Treatment:

Behavioral: Supervised Gait Retraining

Drug: Botulinum Toxin Injection