NCT04409600

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Walter Reed National Military Medical Center · Federal
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Exertional Compartment Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Supervised Gait Retraining	The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
BEHAVIORAL	Home Based Gait Retraining	The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
DRUG	Saline Injection	The participant will receive a saline injection to their painful lower leg compartment(s).
DRUG	Botulinum Toxin Injection	The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).

Timeline

• Start date: 2020-11-05
• Primary completion: 2024-12-06
• Completion: 2024-12-06
• First posted: 2020-06-01
• Last updated: 2026-03-06
• Results posted: 2026-03-06

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study