Chronic Exertional Compartment Syndrome
Conditions
Keywords
botulinum toxin, gait training, military
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.
Interventions
BEHAVIORALSupervised 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.
BEHAVIORALHome 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.
DRUGSaline Injection
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).
Sponsors
Walter Reed National Military Medical Center
Uniformed Services University of the Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants are masked to treatment injection arm. At 3 months post-injection, the treatment injection arm will be revealed to the participant.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| University of Wisconsin Running Injury and Recovery Index Score at Baseline | 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. |
| University of Wisconsin Running Injury and Recovery Index Score at 8 Weeks Post-Injection | 8-week | 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. |
| University of Wisconsin Running Injury and Recovery Index Score at 3-months Post-injection | 3-month | 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. |
| University of Wisconsin Running Injury and Recovery Index Score 6-months Post-injection | 6-month | 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. |
| University of Wisconsin Running Injury and Recovery Index Score at 12-months Post-Injection | 12-month | 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. |
| University of Wisconsin Running Injury and Recovery Index Score at 24-Months Post-Injection | 24-month | 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. |
| Single Assessment Numerical Evaluation (SANE) Score at Baseline | 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. |
| Single Assessment Numerical Evaluation (SANE) 8-weeks Post-Injection | 8-weeks | 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. |
| Single Assessment Numerical Evaluation (SANE) at 3-months Post-Injection | 3-months | 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. |
| Single Assessment Numerical Evaluation (SANE) at 6-months Post-Injection | 6-months | 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. |
| Single Assessment Numerical Evaluation (SANE) at 12-months Post-Injection | 12-months | 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. |
| Single Assessment Numerical Evaluation (SANE) at 24-months Post-Injection | 24-months | 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. |
| Global Rate of Change Score at 8-weeks Post-Injection | 8-weeks | 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. |
| Global Rate of Change Score 3-months Post-Injection | 3-months | 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. |
| Global Rate of Change Score at 6-months Post-Injection | 6-months | 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. |
| Global Rate of Change Score 12-months Post-Injection | 12-months | 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. |
| Global Rate of Change Score at 24-months Post-Injection | 24-months | 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. |
| Duty Status at Baseline | baseline | Question asked to military service members about their current duty status. |
| Duty Status at 8-weeks Post-Injection | 8-weeks | Question asked to military service members about their current duty status. |
| Duty Status at 3-months Post-Injection | 3-months | Question asked to military service members about their current duty status. |
| Duty Status at 6-months Post-Injection | 6-months | Question asked to military service members about their current duty status. |
| Duty Status at 12-months Post-Injection | 12-months | Question asked to military service members about their current duty status. |
| Duty Status at 24-months Post-Injection | 24-months | Question asked to military service members about their current duty status. |
| Patient Specific Functional Scale Scores at Baseline | 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. |
| Patient Specific Functional Scale Scores at 8-weeks Post-Injection | 8-weeks | 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. |
| Patient Specific Functional Scale Scores at 3-months Post-Injection | 3-months | 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. |
| Patient Specific Functional Scale Scores at 6-months Post-Injection | 6-months | 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. |
| Patient Specific Functional Scale Scores at 12-months Post-Injection | 12-months | 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. |
| Patient Specific Functional Scale Scores at 24-months Post-Injection | 24-months | 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. |
| Balance Error Scoring System Score at Baseline | 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. |
| Balance Error Scoring System Score at 8-weeks Post-Injection | 8-weeks | 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. |
| Balance Error Scoring System Score at 3-months Post-Injection | 3-months | 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. |
| Balance Error Scoring System Score at 6-months Post-Injection | 6-months | 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. |
| Balance Error Scoring System Score at 12-months Post-Injection | 12-months | 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. |
| Gait Analysis - Cadence at Baseline | 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. |
| Ability to Run 2 Miles at Baseline | baseline | Question asked to military service members about their ability to run 2 miles. |
| Ability to Run 2 Miles at 8-weeks Post-Injection | 8-weeks | Question asked to military service members about their ability to run 2 miles. |
| Ability to Run 2 Miles at 3-months Post-Injection | 3-months | Question asked to military service members about their ability to run 2 miles. |
| Ability to Run 2 Miles at 6-months Post-Injection | 6-months | Question asked to military service members about their ability to run 2 miles. |
| Ability to Run 2 Miles at 12-months Post-Injection | 12-months | Question asked to military service members about their ability to run 2 miles. |
| Ability to Run 2 Miles at 24-months Post-Injection | 24-months | Question asked to military service members about their ability to run 2 miles. |
| Gait Analysis - Cadence at 8-weeks Post-Injection | 8-Weeks | 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. |
| Gait Analysis - Cadence at 3-months Post-Injection | 3-months | 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. |
| Gait Analysis - Cadence at 6-months Post-Injection | 6-months | 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. |
| Gait Analysis - Cadence at 12-months Post-Injection | 12-months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ability to Perform Service Specific Job Tasks at Baseline | baseline | Question that asks the military service member of their ability to perform service specific job tasks. |
| Ability to Perform Service Specific Job Tasks at 8-weeks Post-Injection | 8-weeks | Question that asks the military service member of their ability to perform service specific job tasks. |
| Ability to Perform Service Specific Job Tasks at 3-months Post-Injection | 3-months | Question that asks the military service member of their ability to perform service specific job tasks. |
| Ability to Perform Service Specific Job Tasks at 6-months Post-Injection | 6-months | Question that asks the military service member of their ability to perform service specific job tasks. |
| Ability to Perform Service Specific Job Tasks at 12-months Post-Injection | 12-months | Question that asks the military service member of their ability to perform service specific job tasks. |
| Ability to Perform Service Specific Job Tasks at 24-months Post-Injection | 24-months | Question that asks the military service member of their ability to perform service specific job tasks. |
| Pain Running 2 Miles at Baseline | 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. |
| Pain Running 2 Miles at 8-weeks Post-Injection | 8-weeks | 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 |
| Pain Running 2 Miles at 3-months Post-Injection | 3-months | 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. |
| Pain Running 2 Miles at 6-months Post-Injection | 6-months | 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. |
| Pain Running 2 Miles at 12-months Post-Injection | 12-months | 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. |
| Pain Running 2 Miles at 24-months Post-Injection | 24-months | 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. |
| Patient Satisfaction of Treatment at 8-week Post-Injection | 8-weeks | 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. |
| Patient Satisfaction of Treatment at 3-months Post-Injection | 3-months | 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. |
| Patient Satisfaction of Treatment at 6-months Post-Injection | 6-months | 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. |
| Patient Satisfaction of Treatment at 12-weeks Post-Injection | 12-months | 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. |
| Patient Satisfaction of Treatment at 24-months Post-Injection | 24-months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJeffrey Leggit, MD
Uniformed Services University of the Health Sciences
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 27 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 7 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 8 | 1 / 7 | 3 / 10 | 3 / 10 |
| serious Total, serious adverse events | 0 / 8 | 0 / 7 | 0 / 10 | 0 / 10 |
Outcome results
None listed