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

Primary Purpose

Chronic Exertional Compartment Syndrome

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Supervised Gait Retraining

Home Based Gait Retraining

Saline Injection

Botulinum Toxin Injection

About this trial

This is an interventional treatment trial for Chronic Exertional Compartment Syndrome focused on measuring botulinum toxin, gait training, military

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Walter Reed National Military Medical CenterRecruiting
Womack Army Medical Center
Carl R. Darnell Army Medical CenterRecruiting
Fort Belvoir Community HospitalRecruiting
Madigan Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Home Based Gait Retraining + Saline Injection

Home Based Gait Retraining + Botulinum Toxin Injection

Supervised Gait Retraining + Saline Injection

Supervised Gait Retraining + Botulinum Toxin Injection

Arm Description

Outcomes

Primary Outcome Measures

Change in Balance Error Scoring System Score

Clinical evaluation tool to assess balance. Individuals are assessed on a firm and flat surface while completing different stances and observed for multiple errors while performing the activity. The higher the number of errors, the greater the deficiency in their balance.

Change in University of Wisconsin Running Injury and Recovery Index Score

9-item questionnaire that assesses an individual's ability to run after a running related injury. Total maximum score is 36 with higher scores indicating no deficiency in their ability to run.

Change in Single Assessment Numerical Evaluation (SANE)

A patient reported outcome measure consisting of 1 question that asks the individual to rate their current level of function compared to their function prior to their injury, on a scale from 0-100. A higher score suggests a higher level of function.

Change in Patient Specific Functional Scale Scores

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.

Change in Global Rate of Change Score

Using a 15 point scale, the individual selects 1 choice to reflect their current perceived health rating compared to a specified time point.

Change in gait analysis

Using wearable technology and slow motion capture camera, gait analysis will be collected.

Change in ability to return to full active duty

Question asked to military service members about their ability to return to full active duty.

Change in ability to run 2 miles

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

Secondary Outcome Measures

Pain reduction

Pain reduction will be assessed using a numeric pain rating scale (NPRS). This is an 11 point Likert scale that reflects the individual's pain level.

Ability to perform service specific military physical training requirements

Question that asks the military service member of their ability to perform service specific physical training requirements.

Patient satisfaction of treatment

Questionnaire asking the individual to rate their satisfaction of treatment from 'exceptional' to 'very poor.'

Full Information

NCT ID

NCT04409600

First Posted

May 7, 2020

Last Updated

September 5, 2023

Sponsor

Walter Reed National Military Medical Center

Collaborators

Uniformed Services University of the Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT04409600

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 5, 2020 (Actual)

Primary Completion Date

April 1, 2024 (Anticipated)

Study Completion Date

November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Walter Reed National Military Medical Center

Collaborators

Uniformed Services University of the Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Exertional Compartment Syndrome

Keywords

botulinum toxin, gait training, military

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

Participant

Masking Description

Participants are masked to treatment injection arm. At 3 months post-injection, the treatment injection arm will be revealed to the participant.

Allocation

Randomized

Enrollment

620 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Home Based Gait Retraining + Saline Injection

Arm Type

Active Comparator

Arm Title

Home Based Gait Retraining + Botulinum Toxin Injection

Arm Type

Experimental

Arm Title

Supervised Gait Retraining + Saline Injection

Arm Type

Active Comparator

Arm Title

Supervised Gait Retraining + Botulinum Toxin Injection

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Supervised Gait Retraining

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Home Based Gait Retraining

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Saline Injection

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Botulinum Toxin Injection

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Balance Error Scoring System Score

Description

Time Frame

baseline, 6 weeks, 3-, 6-, 12-months post injection

Title

Change in University of Wisconsin Running Injury and Recovery Index Score

Description

9-item questionnaire that assesses an individual's ability to run after a running related injury. Total maximum score is 36 with higher scores indicating no deficiency in their ability to run.

Time Frame

baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection

Title

Change in Single Assessment Numerical Evaluation (SANE)

Description

Time Frame

baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection

Title

Change in Patient Specific Functional Scale Scores

Description

Time Frame

baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection

Title

Change in Global Rate of Change Score

Description

Using a 15 point scale, the individual selects 1 choice to reflect their current perceived health rating compared to a specified time point.

Time Frame

6 weeks, 3-, 6-, 12-, 24-, 36-months post injection

Title

Change in gait analysis

Description

Using wearable technology and slow motion capture camera, gait analysis will be collected.

Time Frame

baseline, 6 weeks, 3-, 6-, 12-months post injection

Title

Change in ability to return to full active duty

Description

Question asked to military service members about their ability to return to full active duty.

Time Frame

baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection

Title

Change in ability to run 2 miles

Description

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

Time Frame

baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection

Secondary Outcome Measure Information:

Title

Pain reduction

Description

Pain reduction will be assessed using a numeric pain rating scale (NPRS). This is an 11 point Likert scale that reflects the individual's pain level.

Time Frame

baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection

Title

Ability to perform service specific military physical training requirements

Description

Question that asks the military service member of their ability to perform service specific physical training requirements.

Time Frame

baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection

Title

Patient satisfaction of treatment

Description

Questionnaire asking the individual to rate their satisfaction of treatment from 'exceptional' to 'very poor.'

Time Frame

6 weeks, 3-, 6-, 12-, 24-, 36-months post injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jeffrey Leggit, MD

Phone

301-295-9460

jeff.leggit@usuhs.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Teonette Velasco, DPT

Phone

301-400-4456

teonette.velasco.ctr@usuhs.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey Leggit, MD

Organizational Affiliation

Uniformed Services University of the Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Walter Reed National Military Medical Center

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20307

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jeffrey Leggit

Facility Name

Womack Army Medical Center

City

Fort Bragg

State/Province

North Carolina

ZIP/Postal Code

28310

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Carl R. Darnell Army Medical Center

City

Killeen

State/Province

Texas

ZIP/Postal Code

76544

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Hoellen, ATC

david.hoellen.ctr@usuhs.edu

First Name & Middle Initial & Last Name & Degree

Caleb Dickison, DO

Facility Name

Fort Belvoir Community Hospital

City

Fort Belvoir

State/Province

Virginia

ZIP/Postal Code

22060

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Katie Roberts, ATC, DHSc

kathryn.roberts.ctr@usuhs.edu

First Name & Middle Initial & Last Name & Degree

Chad Hulsopple, LTC, MC, USA

Facility Name

Madigan Army Medical Center

City

Fort Lewis

State/Province

Washington

ZIP/Postal Code

98431

Country

United States

Individual Site Status

Withdrawn

12. IPD Sharing Statement

Learn more about this trial

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

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