Chronic Exertional Compartment Syndrome (CECS) Treated With Abobotulinumtoxin A (NCT05466539) | Clinical Trial Compass
CompletedPhase 4
Chronic Exertional Compartment Syndrome (CECS) Treated With Abobotulinumtoxin A
United States3 participantsStarted 2024-04-25
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Baseline Comparator Group:
Inclusion Criteria:
* Adult male and female runners aged 18-65 years
* Group providing normative values for SWE and needle manometry - ICP assessments
Exclusion Criteria:
* History of Neuromuscular disease, serious soft-tissue injury, fractures, and surgery to the lower limb(s).
Treatment Groups:
Inclusion Criteria:
* Confirmatory pressure values at diagnosis: Pre-exercise \> 15 mmHg; 1-min. post \> 30mmHg; or 5-min. post \> 20mmHg
* Ages 18-65 years inclusive at study onset.
* Ability to adhere to protocol.
* Botulinum toxin naïve (lower extremity). Others previously treated, \> than 6 mos. before study entry.
Exclusion Criteria:
* Diagnosis of comorbid pain conditions, including claudication and/or popliteal artery entrapment syndrome.
* Serious soft tissue injury, fractures, or surgery in the lower limb(s) \< than 12 months before study entry.
* Current need for surgery at any level of the lower extremity.
* Treatment with any drug known to interfere with neuromuscular function (e.g., aminoglycoside antibiotics or neuromuscular blocking agents).
* Any other medical condition, laboratory, or diagnostic procedure finding that might preclude the administration of aboBoNTA (Dysport®).
* Ongoing infection at the injection sites.
* Diagnosed as either resistant or sensitive to botulinum toxin treatment of any type or to any components of Dysport®
* Cow milk protein allergy.
* Vulnerable patient populations such as adults unable to consent, pre…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Absolute change from baseline in the Visual Analog Scale (VAS) at 3 months following treatment