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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: July 1, 2022

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).

Arms, Groups and Cohorts

  • Active Comparator: Home Based Gait Retraining + Saline Injection
  • Experimental: Home Based Gait Retraining + Botulinum Toxin Injection
  • Active Comparator: Supervised Gait Retraining + Saline Injection
  • Experimental: Supervised Gait Retraining + Botulinum Toxin Injection

Clinical Trial Outcome Measures

Primary Measures

  • Change in Balance Error Scoring System Score
    • Time Frame: baseline, 6 weeks, 3-, 6-, 12-months post injection
    • Clinical evaluation tool to assess balance. Individuals are assessed on a firm and flat surface while completing different stances and observed for multiple errors while performing the activity. The higher the number of errors, the greater the deficiency in their balance.
  • Change in University of Wisconsin Running Injury and Recovery Index Score
    • Time Frame: baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
    • 9-item questionnaire that assesses an individual’s ability to run after a running related injury. Total maximum score is 36 with higher scores indicating no deficiency in their ability to run.
  • Change in Single Assessment Numerical Evaluation (SANE)
    • Time Frame: baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
    • A patient reported outcome measure consisting of 1 question that asks the individual to rate their current level of function compared to their function prior to their injury, on a scale from 0-100. A higher score suggests a higher level of function.
  • Change in Patient Specific Functional Scale Scores
    • Time Frame: baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
    • Individuals are asked to self-assess limited activities and measure them on a scale from 0-10 where ’0′ indicates they are able to perform the activity and ’10′ indicates that they are unable to perform the activity prior to their condition.
  • Change in Global Rate of Change Score
    • Time Frame: 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
    • Using a 15 point scale, the individual selects 1 choice to reflect their current perceived health rating compared to a specified time point.
  • Change in gait analysis
    • Time Frame: baseline, 6 weeks, 3-, 6-, 12-months post injection
    • Using wearable technology and slow motion capture camera, gait analysis will be collected.
  • Change in ability to return to full active duty
    • Time Frame: baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
    • Question asked to military service members about their ability to return to full active duty.
  • Change in ability to run 2 miles
    • Time Frame: baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
    • Question asked to military service members about their ability to run 2 miles.

Secondary Measures

  • Pain reduction
    • Time Frame: baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
    • Pain reduction will be assessed using a numeric pain rating scale (NPRS). This is an 11 point Likert scale that reflects the individual’s pain level.
  • Ability to perform service specific military physical training requirements
    • Time Frame: baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
    • Question that asks the military service member of their ability to perform service specific physical training requirements.
  • Patient satisfaction of treatment
    • Time Frame: 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
    • Questionnaire asking the individual to rate their satisfaction of treatment from ‘exceptional’ to ‘very poor.’

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Walter Reed National Military Medical Center
  • Collaborator
    • Uniformed Services University of the Health Sciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jeffrey Leggit, MD, Principal Investigator, Uniformed Services University of the Health Sciences
  • Overall Contact(s)
    • Jeffrey Leggit, MD, 301-295-9460, jeff.leggit@usuhs.edu

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