COMPLETED

Chronic Exertional Compartment Syndrome (CECS) Treated With Abobotulinumtoxin A

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Chronic Exertional Compartment Syndrome (CECS) is a painful condition affecting runners and it is caused by a reversible increase in pressure within a closed compartment in the leg. Currently, to diagnose CECS, a large needle is placed into the muscle to measure pressure, which is invasive and painful. After diagnosis, the gold standard of treatment is surgery, which is also invasive, involves a prolonged return to play, and has a significant number of treatment failures. A growing literature has suggested alternative methods to both diagnosis and treatment that include the use of ultrasound to investigate muscle stiffness with shear wave elastography (SWE), and treatment with botulinum toxin injection into the muscle. The investigators propose a single-site randomized clinical trial to investigate the use of abobotulinumtoxinA in the treatment of CECS. Researchers also look to develop a non-invasive method for the diagnosis of CECS using SWE. To the researchers' knowledge, this is the first randomized study investigating the medication to treat this cause. The study will take place at Emory's outpatient sports medicine clinic. Potential participants will primarily be identified and recruited from the departments of Physical Medicine and Rehabilitation, Orthopedics, Physical Therapy, and Sports medicine as a part of regular clinical care. Participants will be included in the randomized portion of the study if they meet the previously established diagnostic criteria for CECS with compartmental pressure testing. This would be a landmark study to provide evidence for the use of an abobotulinumtoxinA in the treatment of CECS, leading to the potential avoidance of a surgical procedure. It could also change the means of diagnosis without the use of painful and invasive needle pressure testing that would provide patients and athletes with ease of care.

Official Title

Chronic Exertional Compartment Syndrome (CECS) Evaluated With Needle Manometry and Shear Wave Elastography, and Treated With Ultrasound-Guided AbobotulinumtoxinA

Quick Facts

Study Start:2024-04-25
Study Completion:2025-08-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05466539

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult male and female runners aged 18-65 years
  2. * Group providing normative values for SWE and needle manometry - ICP assessments
  1. * History of Neuromuscular disease, serious soft-tissue injury, fractures, and surgery to the lower limb(s).

Contacts and Locations

Principal Investigator

Lee Kneer
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Emory Sports Medicine-Dunwoody
Atlanta, Georgia, 30338
United States
Emory Hawks Sports Medicine Center
Brookhaven, Georgia, 30329
United States

Collaborators and Investigators

Sponsor: Emory University

  • Lee Kneer, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-25
Study Completion Date2025-08-13

Study Record Updates

Study Start Date2024-04-25
Study Completion Date2025-08-13

Terms related to this study

Keywords Provided by Researchers

  • Runners
  • Lower extremity pain
  • Exertional Compartment Syndrome of the Leg

Additional Relevant MeSH Terms

  • Compartment Syndrome of Leg