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

  • STATUS
    Recruiting
  • End date
    Nov 1, 2024
  • participants needed
    620
  • sponsor
    Walter Reed National Military Medical Center
Updated on 7 June 2022

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.

Details
Condition Chronic Exertional Compartment Syndrome
Treatment Saline Injection, botulinum toxin injection, Supervised Gait Retraining, Home Based Gait Retraining
Clinical Study IdentifierNCT04409600
SponsorWalter Reed National Military Medical Center
Last Modified on7 June 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note