Trial · NCT04409600

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

NCT04409600, Phase 2, Completed, Walter Reed National Military Medical Center; results first posted 2026-03-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparison of Non-Surgical Treatment Options for Chronic Exertional Compartment Syndrome (CECS). Trials, record NCT04409600. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04409600

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Comparison of Non-Surgical Treatment Options for Chronic Exertional Compartment Syndrome (CECS)
NCT number: NCT04409600
Status: Completed
Phases: Phase 2
Enrollment: 35 participants, actual
Lead sponsor: Walter Reed National Military Medical Center
Conditions: Chronic Exertional Compartment Syndrome
Interventions: Supervised Gait Retraining, Home Based Gait Retraining, Saline Injection, Botulinum Toxin Injection
First posted: 2020-06-01
Last updated: 2026-03-06
Results first posted: 2026-03-06

Source ClinicalTrials.gov

Registered outcomes62

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	University of Wisconsin Running Injury and Recovery Index Score at Baseline	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.
Primary	University of Wisconsin Running Injury and Recovery Index Score at 8 Weeks Post-Injection	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.
Primary	University of Wisconsin Running Injury and Recovery Index Score at 3-months Post-injection	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.
Primary	University of Wisconsin Running Injury and Recovery Index Score 6-months Post-injection	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.
Primary	University of Wisconsin Running Injury and Recovery Index Score at 12-months Post-Injection	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.
Primary	University of Wisconsin Running Injury and Recovery Index Score at 24-Months Post-Injection	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.
Primary	Single Assessment Numerical Evaluation (SANE) Score at Baseline	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.
Primary	Single Assessment Numerical Evaluation (SANE) 8-weeks Post-Injection	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.
Primary	Single Assessment Numerical Evaluation (SANE) at 3-months Post-Injection	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.
Primary	Single Assessment Numerical Evaluation (SANE) at 6-months Post-Injection	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.

1 to 10 of 62Source ClinicalTrials.gov

See all 62 registered outcomes

Outcomes62

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	University of Wisconsin Running Injury and Recovery Index Score at Baseline	baseline	cumulative score on a 9-item scale	MEAN
PRIMARY	University of Wisconsin Running Injury and Recovery Index Score at 8 Weeks Post-Injection	8-week	Cumulative Score on a 9-item scale	MEAN
PRIMARY	University of Wisconsin Running Injury and Recovery Index Score at 3-months Post-injection	3-month	Cumulative score on a 9-item scale	MEAN
PRIMARY	University of Wisconsin Running Injury and Recovery Index Score 6-months Post-injection	6-month	Cumulative score on a 9-item scale	MEAN
PRIMARY	University of Wisconsin Running Injury and Recovery Index Score at 12-months Post-Injection	12-month	Cumulative Score on a 9-item scale	MEAN
PRIMARY	University of Wisconsin Running Injury and Recovery Index Score at 24-Months Post-Injection	24-month	Cumulative Score on a 9-item scale	MEAN
PRIMARY	Single Assessment Numerical Evaluation (SANE) Score at Baseline	baseline	score on a scale	MEAN
PRIMARY	Single Assessment Numerical Evaluation (SANE) 8-weeks Post-Injection	8-weeks	score on a scale	MEAN
PRIMARY	Single Assessment Numerical Evaluation (SANE) at 3-months Post-Injection	3-months	score on a scale	MEAN
PRIMARY	Single Assessment Numerical Evaluation (SANE) at 6-months Post-Injection	6-months	score on a scale	MEAN

1 to 10 of 62Source ClinicalTrials.gov

See all 62 outcomes

Results by group535

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
University of Wisconsin Running Injury and Recovery Index Score at Baseline	Home Based Gait Retraining + Saline Injection	10.86	Standard Deviation 5.90	cumulative score on a 9-item scale
University of Wisconsin Running Injury and Recovery Index Score at Baseline	Supervised Gait Retraining + Saline Injection	11.86	Standard Deviation 4.95	cumulative score on a 9-item scale
University of Wisconsin Running Injury and Recovery Index Score at Baseline	Home Based Gait Retraining + Botulinum Toxin Injection	12.14	Standard Deviation 3.44	cumulative score on a 9-item scale
University of Wisconsin Running Injury and Recovery Index Score at Baseline	Supervised Gait Retraining + Botulinum Toxin Injection	9.75	Standard Deviation 5.52	cumulative score on a 9-item scale
University of Wisconsin Running Injury and Recovery Index Score at 8 Weeks Post-Injection	Home Based Gait Retraining + Saline Injection	14.14	Standard Deviation 9.30	Cumulative Score on a 9-item scale
University of Wisconsin Running Injury and Recovery Index Score at 8 Weeks Post-Injection	Supervised Gait Retraining + Saline Injection	17.71	Standard Deviation 6.13	Cumulative Score on a 9-item scale
University of Wisconsin Running Injury and Recovery Index Score at 8 Weeks Post-Injection	Home Based Gait Retraining + Botulinum Toxin Injection	20.86	Standard Deviation 7.10	Cumulative Score on a 9-item scale
University of Wisconsin Running Injury and Recovery Index Score at 8 Weeks Post-Injection	Supervised Gait Retraining + Botulinum Toxin Injection	15.67	Standard Deviation 6.59	Cumulative Score on a 9-item scale
University of Wisconsin Running Injury and Recovery Index Score at 3-months Post-injection	Home Based Gait Retraining + Saline Injection	13.40	Standard Deviation 8.41	Cumulative score on a 9-item scale
University of Wisconsin Running Injury and Recovery Index Score at 3-months Post-injection	Supervised Gait Retraining + Saline Injection	14.43	Standard Deviation 6.60	Cumulative score on a 9-item scale

1 to 10 of 535Source ClinicalTrials.gov

See all 535 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Home Based Gait Retraining + Saline Injection	8
Overall Study	STARTED	Supervised Gait Retraining + Saline Injection	7
Overall Study	STARTED	Home Based Gait Retraining + Botulinum Toxin Injection	10
Overall Study	STARTED	Supervised Gait Retraining + Botulinum Toxin Injection	10
Overall Study	COMPLETED	Home Based Gait Retraining + Saline Injection	1
Overall Study	COMPLETED	Supervised Gait Retraining + Saline Injection	1
Overall Study	COMPLETED	Home Based Gait Retraining + Botulinum Toxin Injection	3
Overall Study	COMPLETED	Supervised Gait Retraining + Botulinum Toxin Injection	3
Overall Study	NOT COMPLETED	Home Based Gait Retraining + Saline Injection	7
Overall Study	NOT COMPLETED	Supervised Gait Retraining + Saline Injection	6

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Ankle sprains	Musculoskeletal and connective tissue disorders	Home Based Gait Retraining + Saline Injection		8
other	Ankle sprains	Musculoskeletal and connective tissue disorders	Supervised Gait Retraining + Saline Injection	1	7
other	Ankle sprains	Musculoskeletal and connective tissue disorders	Home Based Gait Retraining + Botulinum Toxin Injection	1	10
other	Ankle sprains	Musculoskeletal and connective tissue disorders	Supervised Gait Retraining + Botulinum Toxin Injection	1	10
other	Tingling	Musculoskeletal and connective tissue disorders	Home Based Gait Retraining + Saline Injection		8
other	Tingling	Musculoskeletal and connective tissue disorders	Supervised Gait Retraining + Saline Injection	0	7
other	Tingling	Musculoskeletal and connective tissue disorders	Home Based Gait Retraining + Botulinum Toxin Injection	0	10
other	Tingling	Musculoskeletal and connective tissue disorders	Supervised Gait Retraining + Botulinum Toxin Injection	2	10
other	Weakness	Musculoskeletal and connective tissue disorders	Home Based Gait Retraining + Saline Injection		8
other	Weakness	Musculoskeletal and connective tissue disorders	Supervised Gait Retraining + Saline Injection	1	7

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Home Based Gait Retraining + Saline Injection	0	8
Total, all-cause mortality	Supervised Gait Retraining + Saline Injection	0	7
Total, all-cause mortality	Home Based Gait Retraining + Botulinum Toxin Injection	0	10
Total, all-cause mortality	Supervised Gait Retraining + Botulinum Toxin Injection	0	10
Total, other adverse events	Home Based Gait Retraining + Saline Injection	0	8
Total, other adverse events	Supervised Gait Retraining + Saline Injection	1	7
Total, other adverse events	Home Based Gait Retraining + Botulinum Toxin Injection	3	10
Total, other adverse events	Supervised Gait Retraining + Botulinum Toxin Injection	3	10
Total, serious adverse events	Home Based Gait Retraining + Saline Injection	0	8
Total, serious adverse events	Supervised Gait Retraining + Saline Injection	0	7

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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GET https://conductscience.org/api/trials/v1/NCT04409600/registered?page=2

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