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

Chronic Exertional Compartment Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04409600
• Other study ID #: WRNMMC-2019-0266
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 5, 2020
• Est. completion date: November 1, 2024

Study information

• Verified date: April 2024
• Source: Walter Reed National Military Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: November 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Exertional Compartment Syndrome
• Compartment Syndromes
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Fort Belvoir Community Hospital	Fort Belvoir	Virginia
United States	Womack Army Medical Center	Fort Bragg	North Carolina
United States	Carl R. Darnell Army Medical Center	Killeen	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Walter Reed National Military Medical Center	Uniformed Services University of the Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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