Phase 2
N=35
Comparison of Non-Surgical Treatment Options for Chronic Exertional Compartment Syndrome (CECS)
Chronic Exertional Compartment Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04409600 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: University of Wisconsin Running Injury and Recovery Index Score at Baseline — 10.86; 11.86; 12.14; 9.75 cumulative score on a 9-item scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Supervised Gait Retraining (Behavioral); Home Based Gait Retraining (Behavioral); Saline Injection (Drug); Botulinum Toxin Injection (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Walter Reed National Military Medical Center
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY University of Wisconsin Running Injury and Recovery Index Score at Baseline |
10.86; 11.86; 12.14; 9.75 | — |
| PRIMARY University of Wisconsin Running Injury and Recovery Index Score at 8 Weeks Post-Injection |
14.14; 17.71; 20.86; 15.67 | — |
| PRIMARY University of Wisconsin Running Injury and Recovery Index Score at 3-months Post-injection |
13.40; 14.43; 20.57; 15.67 | — |
| PRIMARY University of Wisconsin Running Injury and Recovery Index Score 6-months Post-injection |
12.17; 16.40; 22.43; 14.57 | — |
| PRIMARY University of Wisconsin Running Injury and Recovery Index Score at 12-months Post-Injection |
10.83; 21.75; 21.00; 18.80 | — |
| PRIMARY University of Wisconsin Running Injury and Recovery Index Score at 24-Months Post-Injection |
18.00; 36.00; 13.00; 22.33 | — |
| PRIMARY Single Assessment Numerical Evaluation (SANE) Score at Baseline |
74.44; 5357; 58.50; 44.00 | — |
| PRIMARY Single Assessment Numerical Evaluation (SANE) 8-weeks Post-Injection |
66.29; 66.43; 67.50; 51.88 | — |
| PRIMARY Single Assessment Numerical Evaluation (SANE) at 3-months Post-Injection |
65.00; 66.43; 70.00; 47.78 | — |
| PRIMARY Single Assessment Numerical Evaluation (SANE) at 6-months Post-Injection |
60.83; 71.00; 76.67; 61.67 | — |
| PRIMARY Single Assessment Numerical Evaluation (SANE) at 12-months Post-Injection |
64.17; 68.75; 72.00; 52.14 | — |
| PRIMARY Single Assessment Numerical Evaluation (SANE) at 24-months Post-Injection |
90.00; 100.00; 51.67; 76.67 | — |
| PRIMARY Global Rate of Change Score at 8-weeks Post-Injection |
1; 2.43; 3.20; 3.00 | — |
| PRIMARY Global Rate of Change Score 3-months Post-Injection |
2.00; 1.71; 3.78; 1.11 | — |
| PRIMARY Global Rate of Change Score at 6-months Post-Injection |
1.67; 3.20; 5.00; 1.44 | — |
| PRIMARY Global Rate of Change Score 12-months Post-Injection |
0.50; 3.00; 3.20; 2.86 | — |
| PRIMARY Global Rate of Change Score at 24-months Post-Injection |
7.00; 7.00; -0.33; 4.00 | — |
| PRIMARY Duty Status at Baseline |
6; 3; 6; 6; 2; 4 | — |
| PRIMARY Duty Status at 8-weeks Post-Injection |
4; 2; 1; 5; 3; 5 | — |
| PRIMARY Duty Status at 3-months Post-Injection |
1; 4; 1; 4; 5; 3 | — |
| PRIMARY Duty Status at 6-months Post-Injection |
3; 3; 3; 6; 3; 2 | — |
| PRIMARY Duty Status at 12-months Post-Injection |
3; 3; 4; 5; 3; 1 | — |
| PRIMARY Duty Status at 24-months Post-Injection |
1; 0; 2; 2; 0; 1 | — |
| PRIMARY Patient Specific Functional Scale Scores at Baseline |
4.33; 3.98; 3.86; 2.67 | — |
| PRIMARY Patient Specific Functional Scale Scores at 8-weeks Post-Injection |
5.70; 4.99; 5.49; 4.29 | — |
| PRIMARY Patient Specific Functional Scale Scores at 3-months Post-Injection |
3.55; 4.94; 6.09; 3.35 | — |
| PRIMARY Patient Specific Functional Scale Scores at 6-months Post-Injection |
4.68; 6.04; 6.83; 3.62 | — |
| PRIMARY Patient Specific Functional Scale Scores at 12-months Post-Injection |
3.57; 4.46; 5.67; 3.90 | — |
| PRIMARY Patient Specific Functional Scale Scores at 24-months Post-Injection |
10.00; 4.33; 5.00 | — |
| PRIMARY Balance Error Scoring System Score at Baseline |
19.11; 21.14; 21.60; 15.70 | — |
| PRIMARY Balance Error Scoring System Score at 8-weeks Post-Injection |
19.71; 19.29; 23.50; 18.50 | — |
| PRIMARY Balance Error Scoring System Score at 3-months Post-Injection |
14.83; 22.20; 23.00; 14.83 | — |
| PRIMARY Balance Error Scoring System Score at 6-months Post-Injection |
19.80; 22.20; 23.00; 18.44 | — |
| PRIMARY Balance Error Scoring System Score at 12-months Post-Injection |
20.50; 26.50; 25.50; 23.67 | — |
| PRIMARY Gait Analysis - Cadence at Baseline |
161.22; 162.14; 159.80; 158.60 | — |
| PRIMARY Ability to Run 2 Miles at Baseline |
4; 5; 7; 7; 0; 0 | — |
| PRIMARY Ability to Run 2 Miles at 8-weeks Post-Injection |
4; 5; 7; 6; 1; 0 | — |
| PRIMARY Ability to Run 2 Miles at 3-months Post-Injection |
2; 5; 5; 6; 1; 1 | — |
| PRIMARY Ability to Run 2 Miles at 6-months Post-Injection |
2; 4; 1; 6; 0; 0 | — |
| PRIMARY Ability to Run 2 Miles at 12-months Post-Injection |
3; 3; 1; 4; 1; 0 | — |
| PRIMARY Ability to Run 2 Miles at 24-months Post-Injection |
0; 0; 1; 1; 0; 1 | — |
| PRIMARY Gait Analysis - Cadence at 8-weeks Post-Injection |
166.34; 168.00; 167.80; 468.99 | — |
| PRIMARY Gait Analysis - Cadence at 3-months Post-Injection |
171.61; 171.34; 171.71; 173.60 | — |
| PRIMARY Gait Analysis - Cadence at 6-months Post-Injection |
167.51; 175.59; 170.00; 169.11 | — |
| PRIMARY Gait Analysis - Cadence at 12-months Post-Injection |
173.99; 168.99; 16799; 173.01 | — |
| SECONDARY Ability to Perform Service Specific Job Tasks at Baseline |
0; 2; 2; 1; 0; 1 | — |
| SECONDARY Ability to Perform Service Specific Job Tasks at 8-weeks Post-Injection |
1; 3; 1; 0; 0; 0 | — |
| SECONDARY Ability to Perform Service Specific Job Tasks at 3-months Post-Injection |
1; 3; 1; 2; 0; 0 | — |
| SECONDARY Ability to Perform Service Specific Job Tasks at 6-months Post-Injection |
1; 1; 0; 1; 0; 0 | — |
| SECONDARY Ability to Perform Service Specific Job Tasks at 12-months Post-Injection |
2; 1; 0; 1; 0; 0 | — |
| SECONDARY Ability to Perform Service Specific Job Tasks at 24-months Post-Injection |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Pain Running 2 Miles at Baseline |
7.56; 4.42; 7.00; 7.80 | — |
| SECONDARY Pain Running 2 Miles at 8-weeks Post-Injection |
6.14; 5.57; 5.40; 5.75 | — |
| SECONDARY Pain Running 2 Miles at 3-months Post-Injection |
6.00; 4.71; 5.33; 5.67 | — |
| SECONDARY Pain Running 2 Miles at 6-months Post-Injection |
5.67; 2.60; 5.33; 4.78 | — |
| SECONDARY Pain Running 2 Miles at 12-months Post-Injection |
5.17; 3.50; 6.40; 3.00 | — |
| SECONDARY Pain Running 2 Miles at 24-months Post-Injection |
1.00; 0; 8.33; 3.67 | — |
| SECONDARY Patient Satisfaction of Treatment at 8-week Post-Injection |
1; 1; 2; 2; 3; 2 | — |
| SECONDARY Patient Satisfaction of Treatment at 3-months Post-Injection |
1; 0; 3; 3; 2; 2 | — |
| SECONDARY Patient Satisfaction of Treatment at 6-months Post-Injection |
0; 1; 2; 1; 3; 2 | — |
| SECONDARY Patient Satisfaction of Treatment at 12-weeks Post-Injection |
1; 0; 2; 1; 2; 0 | — |
| SECONDARY Patient Satisfaction of Treatment at 24-months Post-Injection |
0; 0; 0; 0; 0; 1 | — |
Summary
Chronic Exertional Compartment Syndrome (CECS) in the lower leg is a debilitating condition in highly active individuals. Pain occurs in 1 or several leg compartments upon an exertional activity, typically running, that quickly dissipates once the activity stopped. Surgical fasciotomy is the standard for treating lower leg CECS, but success is variable. Complications may occur post-surgery and there is a potential for a repeat procedure. Recovery times post-surgery also vary greatly. Conservative treatments, such as gait retraining and botulinum toxin injections, are emerging as non-surgical options for the treatment of CECS with success through published case reports and case series. This study aims to evaluate the use of these non-surgical treatment options for CECS in the anterior and lateral leg compartments with a follow up for at least 2 years across multiple study sites.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04409600). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.