Botulinum for Chronic Exertional Compartment Syndrome

Chronic Exertional Compartment Syndrome Clinical Trial

— Botox  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03339921
• Other study ID #: FWH20170037H
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: December 7, 2018
• Est. completion date: May 1, 2020

Study information

• Verified date: March 2024
• Source: 375th Medical Group, Scott Air Force Base
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Exertional Compartment Syndrome
• Compartment Syndromes
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	375th Medical Group	Scott Air Force Base	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
375th Medical Group, Scott Air Force Base

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower Extremity Functional Index	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.	6 months