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

• Status: Recruiting
• Trial end date: 2025-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Walter Reed National Military Medical Center
• Collaborator: Uniformed Services University of the Health Sciences
• Treatments: Botulinum Toxins

Criteria

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