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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
46
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.
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.
The participant will receive a saline injection to their painful lower leg compartment(s).
The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Womack Army Medical Center
Fort Bragg, North Carolina, United States
Carl R. Darnell Army Medical Center
Killeen, Texas, United States
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
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.
Time frame: 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.
Time frame: 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.'
Time frame: 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
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