Comparison of Non-Surgical Treatment Options for Chronic Exertional Compartment Syndrome (CECS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- University of Wisconsin Running Injury and Recovery Index Score at Baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants are masked to treatment injection arm. At 3 months post-injection, the treatment injection arm will be revealed to the participant.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
Home Based Gait Retraining + Saline Injection
干预措施: Home Based Gait Retraining (Behavioral)
Home Based Gait Retraining + Saline Injection
干预措施: Saline Injection (Drug)
Home Based Gait Retraining + Botulinum Toxin Injection
干预措施: Home Based Gait Retraining (Behavioral)
Home Based Gait Retraining + Botulinum Toxin Injection
干预措施: Botulinum Toxin Injection (Drug)
Supervised Gait Retraining + Saline Injection
干预措施: Supervised Gait Retraining (Behavioral)
Supervised Gait Retraining + Saline Injection
干预措施: Saline Injection (Drug)
Supervised Gait Retraining + Botulinum Toxin Injection
干预措施: Supervised Gait Retraining (Behavioral)
Supervised Gait Retraining + Botulinum Toxin Injection
干预措施: Botulinum Toxin Injection (Drug)
结局指标
主要结局
University of Wisconsin Running Injury and Recovery Index Score at Baseline
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: baseline
Question asked to military service members about their current duty status.
Duty Status at 8-weeks Post-Injection
时间窗: 8-weeks
Question asked to military service members about their current duty status.
Duty Status at 3-months Post-Injection
时间窗: 3-months
Question asked to military service members about their current duty status.
Duty Status at 6-months Post-Injection
时间窗: 6-months
Question asked to military service members about their current duty status.
Duty Status at 12-months Post-Injection
时间窗: 12-months
Question asked to military service members about their current duty status.
Duty Status at 24-months Post-Injection
时间窗: 24-months
Question asked to military service members about their current duty status.
Patient Specific Functional Scale Scores at Baseline
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
Ability to Run 2 Miles at 3-months Post-Injection
时间窗: 3-months
Question asked to military service members about their ability to run 2 miles.
Balance Error Scoring System Score at 6-months Post-Injection
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: baseline
Question asked to military service members about their ability to run 2 miles.
Ability to Run 2 Miles at 8-weeks Post-Injection
时间窗: 8-weeks
Question asked to military service members about their ability to run 2 miles.
Ability to Run 2 Miles at 6-months Post-Injection
时间窗: 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
时间窗: 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
时间窗: 24-months
Question asked to military service members about their ability to run 2 miles.
Gait Analysis - Cadence at 8-weeks Post-Injection
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Ability to Perform Service Specific Job Tasks at Baseline(baseline)
- Ability to Perform Service Specific Job Tasks at 8-weeks Post-Injection(8-weeks)
- Ability to Perform Service Specific Job Tasks at 3-months Post-Injection(3-months)
- Ability to Perform Service Specific Job Tasks at 6-months Post-Injection(6-months)
- Ability to Perform Service Specific Job Tasks at 12-months Post-Injection(12-months)
- Ability to Perform Service Specific Job Tasks at 24-months Post-Injection(24-months)
- Pain Running 2 Miles at Baseline(baseline)
- Pain Running 2 Miles at 8-weeks Post-Injection(8-weeks)
- Pain Running 2 Miles at 3-months Post-Injection(3-months)
- Pain Running 2 Miles at 6-months Post-Injection(6-months)
- Pain Running 2 Miles at 12-months Post-Injection(12-months)
- Pain Running 2 Miles at 24-months Post-Injection(24-months)
- Patient Satisfaction of Treatment at 8-week Post-Injection(8-weeks)
- Patient Satisfaction of Treatment at 3-months Post-Injection(3-months)
- Patient Satisfaction of Treatment at 6-months Post-Injection(6-months)
- Patient Satisfaction of Treatment at 12-weeks Post-Injection(12-months)
- Patient Satisfaction of Treatment at 24-months Post-Injection(24-months)