Chronic Exertional Compartment SyndromePhase 2NCT04409600
Comparison of Non-Surgical Treatment Options for Chronic Exertional Compartment Syndrome (CECS)
A Phase 2 study testing Supervised Gait Retraining, Home Based Gait Retraining and Saline Injection in people with Chronic Exertional Compartment Syndrome, run by Walter Reed National Military Medical Center at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chronic Exertional Compartment Syndrome
- What is being tested?
- Supervised Gait Retraining, Home Based Gait Retraining and Saline Injection
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 4 sitesUnited States
- Study dates
- 5 Nov 2020to 6 Dec 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20307
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, 22060
Womack Army Medical Center
Fort Bragg, North Carolina, 28310
Carl R. Darnell Army Medical Center
Killeen, Texas, 76544
About this study
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.
- Conditions
- Chronic Exertional Compartment Syndrome
- Being tested
- Supervised Gait Retraining, Home Based Gait Retraining, Saline Injection, Botulinum Toxin Injection
- Keywords
- botulinum toxin, gait training, military
- Medical subject headings
- Chronic Exertional Compartment Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Gait RetrainingBehavioural
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 RetrainingBehavioural
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.
Saline InjectionDrug
The participant will receive a saline injection to their painful lower leg compartment(s).
Botulinum Toxin InjectionDrug
The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
| Study group | Role | What they receive |
|---|---|---|
| Home Based Gait Retraining + Saline Injection | Active comparator | Not described Receives: Behavioral: Home Based Gait Retraining; Drug: Saline Injection |
| Home Based Gait Retraining + Botulinum Toxin Injection | Experimental | Not described Receives: Behavioral: Home Based Gait Retraining; Drug: Botulinum Toxin Injection |
| Supervised Gait Retraining + Saline Injection | Active comparator | Not described Receives: Behavioral: Supervised Gait Retraining; Drug: Saline Injection |
| Supervised Gait Retraining + Botulinum Toxin Injection | Experimental | Not described Receives: Behavioral: Supervised Gait Retraining; Drug: Botulinum Toxin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24-months
Duty Status at Baseline
Question asked to military service members about their current duty status.
Measured: baseline
Duty Status at 8-weeks Post-Injection
Question asked to military service members about their current duty status.
Measured: 8-weeks
Duty Status at 3-months Post-Injection
Question asked to military service members about their current duty status.
Measured: 3-months
Duty Status at 6-months Post-Injection
Question asked to military service members about their current duty status.
Measured: 6-months
Duty Status at 12-months Post-Injection
Question asked to military service members about their current duty status.
Measured: 12-months
Duty Status at 24-months Post-Injection
Question asked to military service members about their current duty status.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Ability to Run 2 Miles at Baseline
Question asked to military service members about their ability to run 2 miles.
Measured: baseline
Ability to Run 2 Miles at 8-weeks Post-Injection
Question asked to military service members about their ability to run 2 miles.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12-months
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start5 Nov 2020
- Primary completion6 Dec 2024
- Study completion6 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Exertional Compartment SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Uniformed Services University of the Health Sciences
- Responsible party
- Sponsor
- Investigators
- Jeffrey Leggit, MD, Principal investigator, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409600
- Sponsor's protocol ID
- WRNMMC-2019-0266
- Status last verified
- Mar 2025
- First submitted
- 7 May 2020
- Last updated
- 6 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Non-Surgical Treatment Options for Chronic Exertional Compartment Syndrome (CECS)
- ClinicalTrials.gov ID
- NCT04409600
- Acronym / sponsor ID
- WRNMMC-2019-0266
- Conditions
- Chronic Exertional Compartment Syndrome
- Keywords
- botulinum toxin, gait training, military
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Collaborators
- Uniformed Services University of the Health Sciences
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Posted 6 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Home Based Gait Retraining + Saline Injection | Active comparator | Behavioral: Home Based Gait Retraining, Drug: Saline Injection |
| Home Based Gait Retraining + Botulinum Toxin Injection | Experimental | Behavioral: Home Based Gait Retraining, Drug: Botulinum Toxin Injection |
| Supervised Gait Retraining + Saline Injection | Active comparator | Behavioral: Supervised Gait Retraining, Drug: Saline Injection |
| Supervised Gait Retraining + Botulinum Toxin Injection | Experimental | Behavioral: Supervised Gait Retraining, Drug: Botulinum Toxin Injection |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised Gait RetrainingThe 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. | Behavioural | Supervised Gait Retraining + Botulinum Toxin Injection, Supervised Gait Retraining + Saline Injection |
| Home Based Gait RetrainingThe 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. | Behavioural | Home Based Gait Retraining + Botulinum Toxin Injection, Home Based Gait Retraining + Saline Injection |
| Saline InjectionThe participant will receive a saline injection to their painful lower leg compartment(s). | Drug | Home Based Gait Retraining + Saline Injection, Supervised Gait Retraining + Saline Injection |
| Botulinum Toxin InjectionThe participant will receive a botulinum toxin injection to their painful lower leg compartment(s). | Drug | Home Based Gait Retraining + Botulinum Toxin Injection, Supervised Gait Retraining + Botulinum Toxin Injection |
Primary outcome
University of Wisconsin Running Injury and Recovery Index Score at Baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline
Question asked to military service members about their current duty status.
Duty Status at 8-weeks Post-Injection
Time frame: 8-weeks
Question asked to military service members about their current duty status.
Duty Status at 3-months Post-Injection
Time frame: 3-months
Question asked to military service members about their current duty status.
Duty Status at 6-months Post-Injection
Time frame: 6-months
Question asked to military service members about their current duty status.
Duty Status at 12-months Post-Injection
Time frame: 12-months
Question asked to military service members about their current duty status.
Duty Status at 24-months Post-Injection
Time frame: 24-months
Question asked to military service members about their current duty status.
Patient Specific Functional Scale Scores at Baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline
Question asked to military service members about their ability to run 2 miles.
Ability to Run 2 Miles at 8-weeks Post-Injection
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24-months
Question asked to military service members about their ability to run 2 miles.
Gait Analysis - Cadence at 8-weeks Post-Injection
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
17 secondary outcomes
Ability to Perform Service Specific Job Tasks at Baseline
Time frame: baseline
Ability to Perform Service Specific Job Tasks at 8-weeks Post-Injection
Time frame: 8-weeks
Ability to Perform Service Specific Job Tasks at 3-months Post-Injection
Time frame: 3-months
Ability to Perform Service Specific Job Tasks at 6-months Post-Injection
Time frame: 6-months
Ability to Perform Service Specific Job Tasks at 12-months Post-Injection
Time frame: 12-months
Ability to Perform Service Specific Job Tasks at 24-months Post-Injection
Time frame: 24-months
Pain Running 2 Miles at Baseline
Time frame: baseline
Pain Running 2 Miles at 8-weeks Post-Injection
Time frame: 8-weeks
Pain Running 2 Miles at 3-months Post-Injection
Time frame: 3-months
Pain Running 2 Miles at 6-months Post-Injection
Time frame: 6-months
Pain Running 2 Miles at 12-months Post-Injection
Time frame: 12-months
Pain Running 2 Miles at 24-months Post-Injection
Time frame: 24-months
Patient Satisfaction of Treatment at 8-week Post-Injection
Time frame: 8-weeks
Patient Satisfaction of Treatment at 3-months Post-Injection
Time frame: 3-months
Patient Satisfaction of Treatment at 6-months Post-Injection
Time frame: 6-months
Patient Satisfaction of Treatment at 12-weeks Post-Injection
Time frame: 12-months
Patient Satisfaction of Treatment at 24-months Post-Injection
Time frame: 24-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Leggit, MD principal investigator
Uniformed Services University of the Health Sciences
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Supervised Gait Retraining, Home Based Gait Retraining and Saline Injection in people with Chronic Exertional Compartment Syndrome, run by Walter Reed National Military Medical Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
University of Wisconsin Running Injury and Recovery Index Score at Baseline (time frame: baseline). The study lists 45 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.