Clinical trial NCT04409600: Comparison of Non-Surgical Treatment Options for Chronic Exertional Compartment Syndrome (CECS)
Official title: Comparison of Non-Surgical Treatment Options for Chronic Exertional Compartment Syndrome (CECS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Exertional Compartment Syndrome
Keywords: botulinum toxin, gait training, military
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
Collaborators: name: Uniformed Services University of the Health Sciences
First posted: 2020-06-01
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Balance Error Scoring System Score
timeFrame: baseline, 6 weeks, 3-, 6-, 12-months post injection
measure: Change in University of Wisconsin Running Injury and Recovery Index Score
timeFrame: baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
measure: Change in Single Assessment Numerical Evaluation (SANE)
timeFrame: baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
measure: Change in Patient Specific Functional Scale Scores
timeFrame: baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
measure: Change in Global Rate of Change Score
timeFrame: 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
measure: Change in gait analysis
timeFrame: baseline, 6 weeks, 3-, 6-, 12-months post injection
measure: Change in ability to return to full active duty
timeFrame: baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
measure: Change in ability to run 2 miles
timeFrame: baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
Secondary outcomes:
measure: Pain reduction
timeFrame: baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
measure: Ability to perform service specific military physical training requirements
timeFrame: baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
measure: Patient satisfaction of treatment
timeFrame: 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Fort Bragg
country: United States
facility: Womack Army Medical Center
state: North Carolina
city: Killeen
country: United States
facility: Carl R. Darnell Army Medical Center
state: Texas
city: Fort Belvoir
country: United States
facility: Fort Belvoir Community Hospital
state: Virginia
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: Jeffrey Leggit, MD
role: PRINCIPAL_INVESTIGATOR
References: