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

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

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).

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences

  collaborator FED

• Walter Reed National Military Medical Center

  lead FED

Principal Investigators

• Jeffrey Leggit, MD · Uniformed Services University of the Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-05

Primary Completion

2024-12-06

Completion

2024-12-06

FDA Drug

Yes

Countries

• United States

Study Locations