CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
Saline Injection +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04409600
NCT04409600Phase 2Completed

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

Walter Reed National Military Medical Center·interventional·Posted Jun 1, 2020·Updated Mar 6, 2026

In Brief

A Phase 2 clinical trial evaluating Supervised Gait Retraining, Home Based Gait Retraining, and 2 other interventions for Chronic Exertional Compartment Syndrome. Completed, enrolled 35 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJun 1, 2020
Enrollment StartNov 5, 2020
Primary CompletionDec 6, 2024
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 6.1 years ago

Interventions

Supervised Gait Retrainingbehavioral

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.

Home Based Gait Retrainingbehavioral

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.

Saline Injectiondrug

The participant will receive a saline injection to their painful lower leg compartment(s).

Botulinum Toxin Injectiondrug

The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).