Chronic Exertional Compartment Syndrome (CECS) Treated With Abobotulinumtoxin A
Status:
Not yet recruiting
Trial end date:
2023-04-01
Target enrollment:
Participant gender:
Summary
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.