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

Last updated: March 7, 2025
Sponsor: Walter Reed National Military Medical Center
Overall Status: Completed

Phase

2

Condition

N/A

Treatment

Botulinum Toxin Injection

Saline Injection

Home Based Gait Retraining

Clinical Study ID

NCT04409600
WRNMMC-2019-0266
  • Ages 18-50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 physicaltraining due to pain and/or symptoms in their lower leg

  • Meets clinical diagnostic criteria for CECS of the anterior or lateral compartmentper clinical examination (palpation, intramuscular compartment pressure, lower legMRI).

Exclusion

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

Study Design

Total Participants: 46
Treatment Group(s): 4
Primary Treatment: Botulinum Toxin Injection
Phase: 2
Study Start date:
November 05, 2020
Estimated Completion Date:
December 06, 2024

Connect with a study center

  • Walter Reed National Military Medical Center

    Bethesda, Maryland 20307
    United States

    Site Not Available

  • Womack Army Medical Center

    Fort Bragg, North Carolina 28310
    United States

    Site Not Available

  • Carl R. Darnell Army Medical Center

    Killeen, Texas 76544
    United States

    Site Not Available

  • Fort Belvoir Community Hospital

    Fort Belvoir, Virginia 22060
    United States

    Site Not Available

  • Madigan Army Medical Center

    Fort Lewis, Washington 98431
    United States

    Site Not Available

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