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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Exertional Compartment Syndrome

Intervention / Treatment
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* Behavioral: Supervised Gait Retraining
* Behavioral: Home Based Gait Retraining
* Drug: Saline Injection
* Drug: Botulinum Toxin Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Home Based Gait Retraining + Saline Injection<br> | Behavioral: Home Based Gait Retraining<br>* 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.<br>Drug: Saline Injection<br>* The participant will receive a saline injection to their painful lower leg compartment(s).<br>|
| Experimental: Home Based Gait Retraining + Botulinum Toxin Injection<br> | Behavioral: Home Based Gait Retraining<br>* 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.<br>Drug: Botulinum Toxin Injection<br>* The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).<br>|
| Active Comparator: Supervised Gait Retraining + Saline Injection<br> | Behavioral: Supervised Gait Retraining<br>* 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.<br>Drug: Saline Injection<br>* The participant will receive a saline injection to their painful lower leg compartment(s).<br>|
| Experimental: Supervised Gait Retraining + Botulinum Toxin Injection<br> | Behavioral: Supervised Gait Retraining<br>* 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.<br>Drug: Botulinum Toxin Injection<br>* The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Balance Error Scoring System Score | 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. | baseline, 6 weeks, 3-, 6-, 12-months post injection | 
| Change in University of Wisconsin Running Injury and Recovery Index Score | 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. | baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection | 
| Change in Single Assessment Numerical Evaluation (SANE) | 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. | baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection | 
| Change in Patient Specific Functional Scale Scores | 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. | baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection | 
| Change in Global Rate of Change Score | Using a 15 point scale, the individual selects 1 choice to reflect their current perceived health rating compared to a specified time point. | 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection | 
| Change in gait analysis | Using wearable technology and slow motion capture camera, gait analysis will be collected. | baseline, 6 weeks, 3-, 6-, 12-months post injection | 
| Change in ability to return to full active duty | Question asked to military service members about their ability to return to full active duty. | baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection | 
| Change in ability to run 2 miles | Question asked to military service members about their ability to run 2 miles. | baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction | 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. | baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection | 
| Ability to perform service specific military physical training requirements | Question that asks the military service member of their ability to perform service specific physical training requirements. | baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection | 
| Patient satisfaction of treatment | Questionnaire asking the individual to rate their satisfaction of treatment from 'exceptional' to 'very poor.' | 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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botulinum toxin, gait training, military