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Completed

NCT Number: NCT04409600

Comparison of Non-Surgical Treatment Options for Chronic Exertional Compartment Syndrome (CECS)

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Walter Reed National Military Medical Center, Bethesda, Maryland, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supervised Gait Retraining

Behavioral

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 Retraining

Behavioral

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 injection

Drug

The participant will receive a saline injection to their painful lower leg compartment(s).

Botulinum toxin injection

Drug

The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. Duty Status at Baseline

    Time frame: baseline

    Question asked to military service members about their current duty status.

  19. Duty Status at 8-weeks Post-Injection

    Time frame: 8-weeks

    Question asked to military service members about their current duty status.

  20. Duty Status at 3-months Post-Injection

    Time frame: 3-months

    Question asked to military service members about their current duty status.

  21. Duty Status at 6-months Post-Injection

    Time frame: 6-months

    Question asked to military service members about their current duty status.

  22. Duty Status at 12-months Post-Injection

    Time frame: 12-months

    Question asked to military service members about their current duty status.

  23. Duty Status at 24-months Post-Injection

    Time frame: 24-months

    Question asked to military service members about their current duty status.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. Ability to Run 2 Miles at Baseline

    Time frame: baseline

    Question asked to military service members about their ability to run 2 miles.

  37. 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.

  38. 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.

  39. 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.

  40. 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.

  41. 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.

  42. 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.

  43. 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.

  44. 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.

  45. 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.

Secondary outcomes

  1. Ability to Perform Service Specific Job Tasks at Baseline

    Time frame: baseline

    Question that asks the military service member of their ability to perform service specific job tasks.

  2. Ability to Perform Service Specific Job Tasks at 8-weeks Post-Injection

    Time frame: 8-weeks

    Question that asks the military service member of their ability to perform service specific job tasks.

  3. Ability to Perform Service Specific Job Tasks at 3-months Post-Injection

    Time frame: 3-months

    Question that asks the military service member of their ability to perform service specific job tasks.

  4. Ability to Perform Service Specific Job Tasks at 6-months Post-Injection

    Time frame: 6-months

    Question that asks the military service member of their ability to perform service specific job tasks.

  5. Ability to Perform Service Specific Job Tasks at 12-months Post-Injection

    Time frame: 12-months

    Question that asks the military service member of their ability to perform service specific job tasks.

  6. Ability to Perform Service Specific Job Tasks at 24-months Post-Injection

    Time frame: 24-months

    Question that asks the military service member of their ability to perform service specific job tasks.

  7. Pain Running 2 Miles at Baseline

    Time frame: 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.

  8. Pain Running 2 Miles at 8-weeks Post-Injection

    Time frame: 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

  9. Pain Running 2 Miles at 3-months Post-Injection

    Time frame: 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.

  10. Pain Running 2 Miles at 6-months Post-Injection

    Time frame: 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.

  11. Pain Running 2 Miles at 12-months Post-Injection

    Time frame: 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.

  12. Pain Running 2 Miles at 24-months Post-Injection

    Time frame: 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.

  13. Patient Satisfaction of Treatment at 8-week Post-Injection

    Time frame: 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.

  14. Patient Satisfaction of Treatment at 3-months Post-Injection

    Time frame: 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.

  15. Patient Satisfaction of Treatment at 6-months Post-Injection

    Time frame: 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.

  16. Patient Satisfaction of Treatment at 12-weeks Post-Injection

    Time frame: 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.

  17. Patient Satisfaction of Treatment at 24-months Post-Injection

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Walter Reed National Military Medical Center

Fed

Collaborators

  • Uniformed Services University of the Health Sciences

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 1, 2020
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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