NCT04409600

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

Completed Phase 2 Results posted Last updated 6 March 2026

What this trial tests

Phase 2 trial testing Supervised Gait Retraining in Chronic Exertional Compartment Syndrome in 35 participants. Completed in 6 December 2024.

Timeline

5 November 2020

Primary endpoint
6 December 2024

6 December 2024

Quick facts

Lead sponsor	Walter Reed National Military Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	treatment
Enrollment	35
Start date	5 November 2020
Primary completion	6 December 2024
Estimated completion	6 December 2024
Sites	4 locations across United States

Drugs / interventions tested

• Supervised Gait Retraining
• Home Based Gait Retraining
• Saline Injection
• Botulinum Toxin Injection

Conditions studied

• Chronic Exertional Compartment Syndrome — all drugs for Chronic Exertional Compartment Syndrome →

Sponsor

Walter Reed National Military Medical Center

Who can join

Adults 18 to 50, any sex, with Chronic Exertional Compartment Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

University of Wisconsin Running Injury and Recovery Index Score at Baseline Primary · 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.

Group	Value	95% CI
Home Based Gait Retraining + Saline Injection	10.86	± 5.90
Supervised Gait Retraining + Saline Injection	11.86	± 4.95
Home Based Gait Retraining + Botulinum Toxin Injection	12.14	± 3.44
Supervised Gait Retraining + Botulinum Toxin Injection	9.75	± 5.52

University of Wisconsin Running Injury and Recovery Index Score at 8 Weeks Post-Injection Primary · 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.

Group	Value	95% CI
Home Based Gait Retraining + Saline Injection	14.14	± 9.30
Supervised Gait Retraining + Saline Injection	17.71	± 6.13
Home Based Gait Retraining + Botulinum Toxin Injection	20.86	± 7.10
Supervised Gait Retraining + Botulinum Toxin Injection	15.67	± 6.59

University of Wisconsin Running Injury and Recovery Index Score at 3-months Post-injection Primary · 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.

Group	Value	95% CI
Home Based Gait Retraining + Saline Injection	13.40	± 8.41
Supervised Gait Retraining + Saline Injection	14.43	± 6.60
Home Based Gait Retraining + Botulinum Toxin Injection	20.57	± 4.76
Supervised Gait Retraining + Botulinum Toxin Injection	15.67	± 6.59

University of Wisconsin Running Injury and Recovery Index Score 6-months Post-injection Primary · 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.

Group	Value	95% CI
Home Based Gait Retraining + Saline Injection	12.17	± 7.49
Supervised Gait Retraining + Saline Injection	16.40	± 9.34
Home Based Gait Retraining + Botulinum Toxin Injection	22.43	± 4.72
Supervised Gait Retraining + Botulinum Toxin Injection	14.57	± 7.39

University of Wisconsin Running Injury and Recovery Index Score at 12-months Post-Injection Primary · 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.

Group	Value	95% CI
Home Based Gait Retraining + Saline Injection	10.83	± 6.85
Supervised Gait Retraining + Saline Injection	21.75	± 6.31
Home Based Gait Retraining + Botulinum Toxin Injection	21.00	± 5.23
Supervised Gait Retraining + Botulinum Toxin Injection	18.80	± 13.74

University of Wisconsin Running Injury and Recovery Index Score at 24-Months Post-Injection Primary · 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.

Group	Value	95% CI
Home Based Gait Retraining + Saline Injection	18.00	± 0
Supervised Gait Retraining + Saline Injection	36.00	± 0
Home Based Gait Retraining + Botulinum Toxin Injection	13.00	± 4.58
Supervised Gait Retraining + Botulinum Toxin Injection	22.33	± 14.57

Single Assessment Numerical Evaluation (SANE) Score at Baseline Primary · 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.

Group	Value	95% CI
Home Based Gait Retraining + Saline Injection	74.44	± 15.09
Supervised Gait Retraining + Saline Injection	5357	± 19.73
Home Based Gait Retraining + Botulinum Toxin Injection	58.50	± 12.03
Supervised Gait Retraining + Botulinum Toxin Injection	44.00	± 16.96

Single Assessment Numerical Evaluation (SANE) 8-weeks Post-Injection Primary · 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.

Group	Value	95% CI
Home Based Gait Retraining + Saline Injection	66.29	± 18.50
Supervised Gait Retraining + Saline Injection	66.43	± 21.55
Home Based Gait Retraining + Botulinum Toxin Injection	67.50	± 16.71
Supervised Gait Retraining + Botulinum Toxin Injection	51.88	± 24.49

Single Assessment Numerical Evaluation (SANE) at 3-months Post-Injection Primary · 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.

Group	Value	95% CI
Home Based Gait Retraining + Saline Injection	65.00	± 23.24
Supervised Gait Retraining + Saline Injection	66.43	± 14.06
Home Based Gait Retraining + Botulinum Toxin Injection	70.00	± 17.50
Supervised Gait Retraining + Botulinum Toxin Injection	47.78	± 22.38

Single Assessment Numerical Evaluation (SANE) at 6-months Post-Injection Primary · 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.

Group	Value	95% CI
Home Based Gait Retraining + Saline Injection	60.83	± 23.33
Supervised Gait Retraining + Saline Injection	71.00	± 28.15
Home Based Gait Retraining + Botulinum Toxin Injection	76.67	± 20.46
Supervised Gait Retraining + Botulinum Toxin Injection	61.67	± 25.98

Single Assessment Numerical Evaluation (SANE) at 12-months Post-Injection Primary · 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.

Group	Value	95% CI
Home Based Gait Retraining + Saline Injection	64.17	± 22.89
Supervised Gait Retraining + Saline Injection	68.75	± 22.98
Home Based Gait Retraining + Botulinum Toxin Injection	72.00	± 7.58
Supervised Gait Retraining + Botulinum Toxin Injection	52.14	± 34.38

Single Assessment Numerical Evaluation (SANE) at 24-months Post-Injection Primary · 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.

Group	Value	95% CI
Home Based Gait Retraining + Saline Injection	90.00	± 0.00
Supervised Gait Retraining + Saline Injection	100.00	± 0.00
Home Based Gait Retraining + Botulinum Toxin Injection	51.67	± 7.64
Supervised Gait Retraining + Botulinum Toxin Injection	76.67	± 25.17

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 months. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Home Based Gait Retraining + Saline Injection

Serious: 0/8 (0%)

Deaths: 0/8

Supervised Gait Retraining + Saline Injection

Serious: 0/7 (0%)

Deaths: 0/7

Home Based Gait Retraining + Botulinum Toxin Injection

Serious: 0/10 (0%)

Deaths: 0/10

Supervised Gait Retraining + Botulinum Toxin Injection

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (5 terms — click to expand)

Reaction	System	Home Based Gait Retraining…	Supervised Gait Retraining…	Home Based Gait Retraining…	Supervised Gait Retraining…
Tingling	Musculoskeletal and connective tissue disorders	—	—	—	—
Ankle sprains	Musculoskeletal and connective tissue disorders	—	—	—	—
Weakness	Musculoskeletal and connective tissue disorders	—	—	—	—
Achilles tendon pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Soreness	Musculoskeletal and connective tissue disorders	—	—	—	—

Data from ClinicalTrials.gov NCT04409600 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.