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Completed Phase 4 Interventional Accepts healthy volunteers

Chronic Exertional Compartment Syndrome (CECS) Treated With Abobotulinumtoxin A

ClinicalTrials.gov ID: NCT05466539

Public ClinicalTrials.gov record NCT05466539. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 7:55 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05466539
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Emory University
Other
Enrollment
3 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 24, 2024
Primary completion
Aug 12, 2025
Completion
Aug 12, 2025
Last update posted
Oct 20, 2025

2024 – 2025

United States locations

U.S. sites
2
U.S. states
1
U.S. cities
2
Facility City State ZIP Site status
Emory Sports Medicine-Dunwoody Atlanta Georgia 30338
Emory Hawks Sports Medicine Center Brookhaven Georgia 30329

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05466539, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 20, 2025 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05466539 live on ClinicalTrials.gov.

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