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
35
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
University of Wisconsin Running Injury and Recovery Index Score at Baseline
The UWRI is scored based on points assigned from self-reported evaluations of running capability. 9 questions are scored on a Likert Scale from 0 to 4, indicating ranges from incapable to optimal function, respectively. The total score can range from 0-36; higher scores indicates better running ability.
Time frame: baseline
University of Wisconsin Running Injury and Recovery Index Score at 8 Weeks Post-Injection
The UWRI is scored based on points assigned from self-reported evaluations of running capability. 9 questions are scored on a Likert Scale from 0 to 4, indicating ranges from incapable to optimal function, respectively. The total score can range from 0-36; higher scores indicates better running ability.
Time frame: 8-week
University of Wisconsin Running Injury and Recovery Index Score at 3-months Post-injection
The UWRI is scored based on points assigned from self-reported evaluations of running capability. 9 questions are scored on a Likert Scale from 0 to 4, indicating ranges from incapable to optimal function, respectively. The total score can range from 0-36; higher scores indicates better running ability.
Time frame: 3-month
University of Wisconsin Running Injury and Recovery Index Score 6-months Post-injection
The UWRI is scored based on points assigned from self-reported evaluations of running capability. 9 questions are scored on a Likert Scale from 0 to 4, indicating ranges from incapable to optimal function, respectively. The total score can range from 0-36; higher scores indicate better running ability.
Time frame: 6-month
University of Wisconsin Running Injury and Recovery Index Score at 12-months Post-Injection
The UWRI is scored based on points assigned from self-reported evaluations of running capability. 9 questions are scored on a Likert Scale from 0 to 4, indicating ranges from incapable to optimal function, respectively. The total score can range from 0-36; higher scores indicate better running ability.
Time frame: 12-month
University of Wisconsin Running Injury and Recovery Index Score at 24-Months Post-Injection
The UWRI is scored based on points assigned from self-reported evaluations of running capability. 9 questions are scored on a Likert Scale from 0 to 4, indicating ranges from incapable to optimal function, respectively. The total score can range from 0-36; higher scores indicate better running ability.
Time frame: 24-month
Single Assessment Numerical Evaluation (SANE) Score at Baseline
A patient reported outcome measure consisting of 1 question that asks the individual to rate their current level of function on a scale from 0-100. A higher score suggests a higher level of function.
Time frame: baseline
Single Assessment Numerical Evaluation (SANE) 8-weeks Post-Injection
A patient reported outcome measure consisting of 1 question that asks the individual to rate their current level of function on a scale from 0-100. A higher score suggests a higher level of function.
Time frame: 8-weeks
Single Assessment Numerical Evaluation (SANE) at 3-months Post-Injection
A patient reported outcome measure consisting of 1 question that asks the individual to rate their current level of function on a scale from 0-100. A higher score suggests a higher level of function.
Time frame: 3-months
Single Assessment Numerical Evaluation (SANE) at 6-months Post-Injection
A patient reported outcome measure consisting of 1 question that asks the individual to rate their current level of function on a scale from 0-100. A higher score suggests a higher level of function.
Time frame: 6-months
Single Assessment Numerical Evaluation (SANE) at 12-months Post-Injection
A patient reported outcome measure consisting of 1 question that asks the individual to rate their current level of function on a scale from 0-100. A higher score suggests a higher level of function.
Time frame: 12-months
Single Assessment Numerical Evaluation (SANE) at 24-months Post-Injection
A patient reported outcome measure consisting of 1 question that asks the individual to rate their current level of function on a scale from 0-100. A higher score suggests a higher level of function.
Time frame: 24-months
Global Rate of Change Score at 8-weeks Post-Injection
Global Rating of Change (GROC) is scored on a Likert Scale ranging from -7 to 7, indicating a range of self-perceived overall change in function at that time point compared to the baseline. Positive higher numbers indicate positive (improvement) and negative lower numbers indicate negative (decline). The participant chooses one number on the scale. Score ranges: (-) 7: A very great deal worse, (-) 6: A great deal worse, (-) 5: Quite a bit worse, (-) 4: Moderately worse, (-) 3: Somewhat worse, (-) 2: A little bit worse, (-) 1: A tiny bit worse (almost the same), (+) 1: A tiny bit better (almost the same), (+) 2: A little but better, (+) 3: Somewhat better, (+) 4: Moderately better, (+) 5: Quite a bit better, (+) 6: A great deal better, (+) 7: A very great deal better.
Time frame: 8-weeks
Global Rate of Change Score 3-months Post-Injection
Global Rating of Change (GROC) is scored on a Likert Scale ranging from -7 to 7, indicating a range of self-perceived overall change in function at that time point compared to the baseline. Positive higher numbers indicate positive (improvement) and negative lower numbers indicate negative (decline). The participant chooses one number on the scale. Score ranges: (-) 7: A very great deal worse, (-) 6: A great deal worse, (-) 5: Quite a bit worse, (-) 4: Moderately worse, (-) 3: Somewhat worse, (-) 2: A little bit worse, (-) 1: A tiny bit worse (almost the same), (+) 1: A tiny bit better (almost the same), (+) 2: A little but better, (+) 3: Somewhat better, (+) 4: Moderately better, (+) 5: Quite a bit better, (+) 6: A great deal better, (+) 7: A very great deal better.
Time frame: 3-months
Global Rate of Change Score at 6-months Post-Injection
Global Rating of Change (GROC) is scored on a Likert Scale ranging from -7 to 7, indicating a range of self-perceived overall change in function at that time point compared to the baseline. Positive higher numbers indicate positive (improvement) and negative lower numbers indicate negative (decline). The participant chooses one number on the scale. Score ranges: (-) 7: A very great deal worse, (-) 6: A great deal worse, (-) 5: Quite a bit worse, (-) 4: Moderately worse, (-) 3: Somewhat worse, (-) 2: A little bit worse, (-) 1: A tiny bit worse (almost the same), (+) 1: A tiny bit better (almost the same), (+) 2: A little but better, (+) 3: Somewhat better, (+) 4: Moderately better, (+) 5: Quite a bit better, (+) 6: A great deal better, (+) 7: A very great deal better.
Time frame: 6-months
Global Rate of Change Score 12-months Post-Injection
Global Rating of Change (GROC) is scored on a Likert Scale ranging from -7 to 7, indicating a range of self-perceived overall change in function at that time point compared to the baseline. Positive higher numbers indicate positive (improvement) and negative lower numbers indicate negative (decline). The participant chooses one number on the scale. Score ranges: (-) 7: A very great deal worse, (-) 6: A great deal worse, (-) 5: Quite a bit worse, (-) 4: Moderately worse, (-) 3: Somewhat worse, (-) 2: A little bit worse, (-) 1: A tiny bit worse (almost the same), (+) 1: A tiny bit better (almost the same), (+) 2: A little but better, (+) 3: Somewhat better, (+) 4: Moderately better, (+) 5: Quite a bit better, (+) 6: A great deal better, (+) 7: A very great deal better.
Time frame: 12-months
Global Rate of Change Score at 24-months Post-Injection
Global Rating of Change (GROC) is scored on a Likert Scale ranging from -7 to 7, indicating a range of self-perceived overall change in function at that time point compared to the baseline. Positive higher numbers indicate positive (improvement) and negative lower numbers indicate negative (decline). The participant chooses one number on the scale. Score ranges: (-) 7: A very great deal worse, (-) 6: A great deal worse, (-) 5: Quite a bit worse, (-) 4: Moderately worse, (-) 3: Somewhat worse, (-) 2: A little bit worse, (-) 1: A tiny bit worse (almost the same), (+) 1: A tiny bit better (almost the same), (+) 2: A little but better, (+) 3: Somewhat better, (+) 4: Moderately better, (+) 5: Quite a bit better, (+) 6: A great deal better, (+) 7: A very great deal better.
Time frame: 24-months
Duty Status at Baseline
Question asked to military service members about their current duty status.
Time frame: baseline
Duty Status at 8-weeks Post-Injection
Question asked to military service members about their current duty status.
Time frame: 8-weeks
Duty Status at 3-months Post-Injection
Question asked to military service members about their current duty status.
Time frame: 3-months
Duty Status at 6-months Post-Injection
Question asked to military service members about their current duty status.
Time frame: 6-months
Duty Status at 12-months Post-Injection
Question asked to military service members about their current duty status.
Time frame: 12-months
Duty Status at 24-months Post-Injection
Question asked to military service members about their current duty status.
Time frame: 24-months
Patient Specific Functional Scale Scores at Baseline
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. The reported values represent an average across all activities.
Time frame: baseline
Patient Specific Functional Scale Scores at 8-weeks 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. The reported values represent an average across all activities.
Time frame: 8-weeks
Patient Specific Functional Scale Scores at 3-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. The reported values represent an average across all activities.
Time frame: 3-months
Patient Specific Functional Scale Scores at 6-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. The reported values represent an average across all activities.
Time frame: 6-months
Patient Specific Functional Scale Scores at 12-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. The reported values represent an average across all activities.
Time frame: 12-months
Patient Specific Functional Scale Scores at 24-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. The reported values represent an average across all activities.
Time frame: 24-months
Balance Error Scoring System Score at Baseline
The Balance Error Scoring System (BESS) is scored based on a cumulative score comprised of six testing conditions, each scored based the amount of errors committed during a testing condition. Each test has a maximum of 10 errors, resulting in a total score ranging from 0 to 60 with higher scores indicating more committed mistakes and poorer balance.
Time frame: baseline
Balance Error Scoring System Score at 8-weeks Post-Injection
The Balance Error Scoring System (BESS) is scored based on a cumulative score comprised of six testing conditions, each scored based the amount of errors committed during a testing condition. Each test has a maximum of 10 errors, resulting in a total score ranging from 0 to 60 with higher scores indicating more committed mistakes and poorer balance.
Time frame: 8-weeks
Balance Error Scoring System Score at 3-months Post-Injection
The Balance Error Scoring System (BESS) is scored based on a cumulative score comprised of six testing conditions, each scored based the amount of errors committed during a testing condition. Each test has a maximum of 10 errors, resulting in a total score ranging from 0 to 60 with higher scores indicating more committed mistakes and poorer balance.
Time frame: 3-months
Balance Error Scoring System Score at 6-months Post-Injection
The Balance Error Scoring System (BESS) is scored based on a cumulative score comprised of six testing conditions, each scored based the amount of errors committed during a testing condition. Each test has a maximum of 10 errors, resulting in a total score ranging from 0 to 60 with higher scores indicating more committed mistakes and poorer balance.
Time frame: 6-months
Balance Error Scoring System Score at 12-months Post-Injection
The Balance Error Scoring System (BESS) is scored based on a cumulative score comprised of six testing conditions, each scored based the amount of errors committed during a testing condition. Each test has a maximum of 10 errors, resulting in a total score ranging from 0 to 60 with higher scores indicating more committed mistakes and poorer balance.
Time frame: 12-months
Gait Analysis - Cadence at Baseline
Using wearable technology and slow motion capture camera, gait analysis will be collected. Post-run, cadence was calculated by testing administrators by reviewing the video captured to count the steps performed over the course of ten seconds. The count over the course of ten seconds was then multiplied by six to serve as a measurement for the unit of steps per minute using previously validated estimation methods.
Time frame: Baseline
Ability to Run 2 Miles at Baseline
Question asked to military service members about their ability to run 2 miles.
Time frame: baseline
Ability to Run 2 Miles at 8-weeks Post-Injection
Question asked to military service members about their ability to run 2 miles.
Time frame: 8-weeks
Ability to Run 2 Miles at 3-months Post-Injection
Question asked to military service members about their ability to run 2 miles.
Time frame: 3-months
Ability to Run 2 Miles at 6-months Post-Injection
Question asked to military service members about their ability to run 2 miles.
Time frame: 6-months
Ability to Run 2 Miles at 12-months Post-Injection
Question asked to military service members about their ability to run 2 miles.
Time frame: 12-months
Ability to Run 2 Miles at 24-months Post-Injection
Question asked to military service members about their ability to run 2 miles.
Time frame: 24-months
Gait Analysis - Cadence at 8-weeks Post-Injection
Using wearable technology and slow motion capture camera, gait analysis will be collected. Post-run, cadence was calculated by testing administrators by reviewing the video captured to count the steps performed over the course of ten seconds. The count over the course of ten seconds was then multiplied by six to serve as a measurement for the unit of steps per minute using previously validated estimation methods.
Time frame: 8-Weeks
Gait Analysis - Cadence at 3-months Post-Injection
Using wearable technology and slow motion capture camera, gait analysis will be collected. Post-run, cadence was calculated by testing administrators by reviewing the video captured to count the steps performed over the course of ten seconds. The count over the course of ten seconds was then multiplied by six to serve as a measurement for the unit of steps per minute using previously validated estimation methods.
Time frame: 3-months
Gait Analysis - Cadence at 6-months Post-Injection
Using wearable technology and slow motion capture camera, gait analysis will be collected. Post-run, cadence was calculated by testing administrators by reviewing the video captured to count the steps performed over the course of ten seconds. The count over the course of ten seconds was then multiplied by six to serve as a measurement for the unit of steps per minute using previously validated estimation methods.
Time frame: 6-months
Gait Analysis - Cadence at 12-months Post-Injection
Using wearable technology and slow motion capture camera, gait analysis will be collected. Post-run, cadence was calculated by testing administrators by reviewing the video captured to count the steps performed over the course of ten seconds. The count over the course of ten seconds was then multiplied by six to serve as a measurement for the unit of steps per minute using previously validated estimation methods.
Time frame: 12-months
Ability to Perform Service Specific Job Tasks at Baseline
Question that asks the military service member of their ability to perform service specific job tasks.
Time frame: baseline
Ability to Perform Service Specific Job Tasks at 8-weeks Post-Injection
Question that asks the military service member of their ability to perform service specific job tasks.
Time frame: 8-weeks
Ability to Perform Service Specific Job Tasks at 3-months Post-Injection
Question that asks the military service member of their ability to perform service specific job tasks.
Time frame: 3-months
Ability to Perform Service Specific Job Tasks at 6-months Post-Injection
Question that asks the military service member of their ability to perform service specific job tasks.
Time frame: 6-months
Ability to Perform Service Specific Job Tasks at 12-months Post-Injection
Question that asks the military service member of their ability to perform service specific job tasks.
Time frame: 12-months
Ability to Perform Service Specific Job Tasks at 24-months Post-Injection
Question that asks the military service member of their ability to perform service specific job tasks.
Time frame: 24-months
Pain Running 2 Miles at Baseline
Pain will be measured using the Numeric Pain Rating Scale (NPRS); An 11 point Likert Scale ranging from 0 to 10 with which participants are asked to rate their pain after completing a 2-mile run. Higher numbers approaching 10 indicate greater, more severe pain, whereas lower numbers approaching 0 indicate reduced or absence of pain.
Time frame: baseline
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Pain Running 2 Miles at 8-weeks Post-Injection
Pain will be measured using the Numeric Pain Rating Scale (NPRS); An 11 point Likert Scale ranging from 0 to 10 with which participants are asked to rate their pain after completing a 2-mile run. Higher numbers approaching 10 indicate greater, more severe pain, whereas lower numbers approaching 0 indicate reduced or absence of pain
Time frame: 8-weeks
Pain Running 2 Miles at 3-months Post-Injection
Pain will be measured using the Numeric Pain Rating Scale (NPRS); An 11 point Likert Scale ranging from 0 to 10 with which participants are asked to rate their pain after completing a 2-mile run. Higher numbers approaching 10 indicate greater, more severe pain, whereas lower numbers approaching 0 indicate reduced or absence of pain.
Time frame: 3-months
Pain Running 2 Miles at 6-months Post-Injection
Pain will be measured using the Numeric Pain Rating Scale (NPRS); An 11 point Likert Scale ranging from 0 to 10 with which participants are asked to rate their pain after completing a 2-mile run. Higher numbers approaching 10 indicate greater, more severe pain, whereas lower numbers approaching 0 indicate reduced or absence of pain.
Time frame: 6-months
Pain Running 2 Miles at 12-months Post-Injection
Pain will be measured using the Numeric Pain Rating Scale (NPRS); An 11 point Likert Scale ranging from 0 to 10 with which participants are asked to rate their pain after completing a 2-mile run. Higher numbers approaching 10 indicate greater, more severe pain, whereas lower numbers approaching 0 indicate reduced or absence of pain.
Time frame: 12-months
Pain Running 2 Miles at 24-months Post-Injection
Pain will be measured using the Numeric Pain Rating Scale (NPRS); An 11 point Likert Scale ranging from 0 to 10 with which participants are asked to rate their pain after completing a 2-mile run. Higher numbers approaching 10 indicate greater, more severe pain, whereas lower numbers approaching 0 indicate reduced or absence of pain.
Time frame: 24-months
Patient Satisfaction of Treatment at 8-week Post-Injection
Questionnaire asking the individual to rate their satisfaction of treatment by choosing one option from the following scale: (1): Exceptional, (2): Excellent, (3): Very Good, (4): Good, (5): Fair, (6): Poor, (7): Very Poor.
Time frame: 8-weeks
Patient Satisfaction of Treatment at 3-months Post-Injection
Questionnaire asking the individual to rate their satisfaction of treatment by choosing one option from the following scale: (1): Exceptional, (2): Excellent, (3): Very Good, (4): Good, (5): Fair, (6): Poor, (7): Very Poor.
Time frame: 3-months
Patient Satisfaction of Treatment at 6-months Post-Injection
Questionnaire asking the individual to rate their satisfaction of treatment by choosing one option from the following scale: (1): Exceptional, (2): Excellent, (3): Very Good, (4): Good, (5): Fair, (6): Poor, (7): Very Poor.
Time frame: 6-months
Patient Satisfaction of Treatment at 12-weeks Post-Injection
Questionnaire asking the individual to rate their satisfaction of treatment by choosing one option from the following scale: (1): Exceptional, (2): Excellent, (3): Very Good, (4): Good, (5): Fair, (6): Poor, (7): Very Poor.
Time frame: 12-months
Patient Satisfaction of Treatment at 24-months Post-Injection
Questionnaire asking the individual to rate their satisfaction of treatment by choosing one option from the following scale: (1): Exceptional, (2): Excellent, (3): Very Good, (4): Good, (5): Fair, (6): Poor, (7): Very Poor.
Time frame: 24-months