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Botulinum for Chronic Exertional Compartment Syndrome (Botox)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03339921
Recruitment Status : Terminated (This study is being closed because it is unworkable.)
First Posted : November 13, 2017
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
375th Medical Group, Scott Air Force Base

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Exertional Compartment Syndrome Drug: Botulinum toxin injections for chronic compartment syndrome Procedure: surgical fasciotomy for chronic compartment syndrome Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Botulinum Toxin to Fasciotomy in Treatment of Chronic Exertional Compartment Syndrome
Actual Study Start Date : December 7, 2018
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : May 1, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Botulinum toxin injections
Botulinum toxin injections for chronic compartment syndrome
 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
Active Comparator: surgical fasciotomy
surgical fasciotomy for chronic compartment syndrome
 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


Outcome Measures
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Primary Outcome Measures :
  1. Lower Extremity Function index [ Time Frame: 6 months ]
    Pain relief and increased function


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339921


Locations
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United States, Illinois
375th Medical Group
Scott Air Force Base, Illinois, United States, 62225
Sponsors and Collaborators
375th Medical Group, Scott Air Force Base
Investigators
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Principal Investigator: Brett Boyce, MD Principal Investigator
More Information
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Responsible Party: 375th Medical Group, Scott Air Force Base
ClinicalTrials.gov Identifier: NCT03339921    
Other Study ID Numbers: FWH20170037H
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Compartment Syndromes
Chronic Exertional Compartment Syndrome
Syndrome
Disease
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Vascular Diseases
 Cardiovascular Diseases
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs