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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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03339921
Study type Interventional
Source 375th Medical Group, Scott Air Force Base
Contact
Status Terminated
Phase Phase 2/Phase 3
Start date December 7, 2018
Completion date May 1, 2020

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04409600 - Comparison of Non-Surgical Treatment Options for Chronic Exertional Compartment Syndrome (CECS) Phase 2
Not yet recruiting NCT05765071 - Treatment of Lower Leg Anterolateral Chronic Exertional Compartment Syndrome With Intra-muscular Botulinum Injections. N/A
Completed NCT05247541 - Diagnosing Compartment Syndrome With SHAPE vs Elastography Phase 2/Phase 3
Active, not recruiting NCT03736174 - Utilization of High Frequency Ultrasound to Diagnose Chronic Exertional Compartment Syndrome