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

NCT ID: NCT04409600

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-05
• Study Completion Date: 2024-12-06

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Home Based Gait Retraining + Saline Injection

Group Type: ACTIVE_COMPARATOR

Home Based Gait Retraining

Intervention Type: BEHAVIORAL

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 Injection

Intervention Type: DRUG

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

Home Based Gait Retraining + Botulinum Toxin Injection

Group Type: EXPERIMENTAL

Home Based Gait Retraining

Intervention Type: BEHAVIORAL

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.

Botulinum Toxin Injection

Intervention Type: DRUG

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

Supervised Gait Retraining + Saline Injection

Group Type: ACTIVE_COMPARATOR

Supervised Gait Retraining

Intervention Type: BEHAVIORAL

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.

Saline Injection

Intervention Type: DRUG

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

Supervised Gait Retraining + Botulinum Toxin Injection

Group Type: EXPERIMENTAL

Supervised Gait Retraining

Intervention Type: BEHAVIORAL

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.

Botulinum Toxin Injection

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Saline Injection

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

Intervention Type: DRUG

Botulinum Toxin Injection

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uniformed Services University of the Health Sciences

FED

Sponsor Role: collaborator

Walter Reed National Military Medical Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Leggit, MD

Role: PRINCIPAL_INVESTIGATOR

Uniformed Services University of the Health Sciences

Locations

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Womack Army Medical Center

Fort Bragg, North Carolina, United States

Carl R. Darnell Army Medical Center

Killeen, Texas, United States

Fort Belvoir Community Hospital

Fort Belvoir, Virginia, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

WRNMMC-2019-0266

Identifier Type: -

Identifier Source: org_study_id