TerminatedPhase 2/3

Botulinum for Chronic Exertional Compartment Syndrome

Stopped: This study is being closed because it is unworkable.

United States3 participantsStarted 2018-12-07

Plain-language summary

We will investigate the feasibility of a simple outpatient one time injection regimen for the treatment of Chronic Exertional Compartment Syndrome (CECS). We think botulinum toxin injections will be a potentially cost-effective, low-risk alternative to surgery in reducing pain and returning patients to full activity.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult ages 18-65 * Active duty military * Unable to run 1.5 miles without producing symptoms, including aching, burning, numbness, tingling, or weakness in the affected limb * Failed conservative treatment over a period of 2 months, including trial of rest, NSAIDs, icing, and stretching routine * Meets standard of care clinical diagnostic intramuscular compartment pressure criteria for CECS, based on standardized IMP needle testing. See below for testing protocol and criteria. Exclusion Criteria: * Prior Botulinum toxin injections into the affected limb * Prior compartment release of the affected limb * Pregnant or becomes pregnant during the study * Standard of care clinical exams indicating other more likely causes of leg pain

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Lower Extremity Functional Index

Timeframe: 6 months

Trial details

NCT IDNCT03339921

Sponsor375th Medical Group, Scott Air Force Base

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2020-05-01

Results submitted2024-01-17

View on ClinicalTrials.gov More Chronic Exertional Compartment Syndrome trials