Botulinum for Chronic Exertional Compartment Syndrome

Phase 2

Terminated

• Conditions: Chronic Exertional Compartment Syndrome
• Interventions: Drug: Botulinum toxin injections for chronic compartment syndrome; Procedure: surgical fasciotomy for chronic compartment syndrome

• Registration Number: NCT03339921
• Lead Sponsor: 375th Medical Group, Scott Air Force Base

Brief 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.

Study Timeline

• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-13
• Study Start: 2018-12-07
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01
• Results First Submitted: 2024-01-17
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-04
• Last Update Submitted: 2024-03-04
• Results First Posted: 2024-03-05
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botulinum toxin injections	Botulinum toxin injections for chronic compartment syndrome	Botulinum toxin injections for chronic compartment syndrome
surgical fasciotomy	surgical fasciotomy for chronic compartment syndrome	surgical fasciotomy for chronic compartment syndrome

Primary Outcome Measures

Name	Time	Method
Lower Extremity Functional Index	6 months	The Lower Extremity Functional Index measures the functional impairment of a patient with a lower extremity disorder. It can be used to monitor the patient over time and to evaluate the effectiveness of an intervention. Score ranges from 0 to 80. Lower scores indicate more functional impairment.

Trial Locations

Locations (1)

375th Medical Group; 🇺🇸 Scott Air Force Base, Illinois, United States