NCT03339921

Botulinum for Chronic Exertional Compartment Syndrome

Comparison of Botulinum Toxin to Fasciotomy in Treatment of Chronic Exertional Compartment Syndrome

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: 375th Medical Group, Scott Air Force Base · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will be a prospective cohort pilot study designed to compare Active Duty patients, 18 years of age or older, with Chronic Exertional Compartment Syndrome (CECS) undergoing two different treatment interventions. The first arm will be patients receiving investigational botulinum toxin injections. The second arm will be patients who undergo the standard of care surgical fasciotomy. Both arms will be evaluated for pain relief with the universal pain scale and lower extremity functional index (LEFI) surveys at pre-treatment and again at one, three, and six months post-treatment. Clinical data that will be analyzed for research purposes in both groups include age, sex, height, weight, body mass index, time to diagnosis, minutes of exercise prior to onset of symptoms, minutes of rest before relief of symptoms, LEFI and pain on the Universal Pain Assessment Tool.

Conditions

• Chronic Exertional Compartment Syndrome

Interventions

Type	Name	Description
DRUG	Botulinum toxin injections for chronic compartment syndrome	Botulinum toxin will be injected in the upper and lower portion of the affected area with a syringe
PROCEDURE	surgical fasciotomy for chronic compartment syndrome	linear incisions will be made into the affected compartment releasing the underlying fascial layer, reducing the pressure of the compartment

Timeline

• Start date: 2018-12-07
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2017-11-13
• Last updated: 2024-03-05
• Results posted: 2024-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study