Botulinum injections for anterolateral lower-leg chronic exertional compartment syndrome
Official title: Treatment of Lower Leg Anterolateral Chronic Exertional Compartment Syndrome With Intra-muscular Botulinum Injections.
Run by University of Calgary · NCT05765071 · Data updated 2026-11-12
This will test whether botulinum toxin injections into the lower-leg muscles reduce exercise-related pain in adults with anterolateral CECS.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Status | Recruiting |
| Started | July 17, 2025 |
| Main results expected | June 30, 2028 |
| Study ends | June 30, 2028 |
| Registry record updated | May 13, 2026 |
| Trial ID | NCT05765071 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with confirmed anterolateral lower-leg CECS by post-exertional compartment pressures (immediate >30 mmHg and 5-minute >12 mmHg) who can attend the University of Calgary for injection and follow-up.
✕Probably not a fit
Patients with CECS affecting other compartments, those who are pregnant or breastfeeding, people with significant neurologic disorders, or those with contraindications to botulinum toxin may not receive benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a triple-blind randomized trial comparing intramuscular botulinum toxin A injections to a normal saline placebo for anterolateral lower-leg CECS. Adults with CECS confirmed by post-exertional compartment pressure measurements will receive the assigned injection at the University of Calgary. Participants complete baseline and web-based follow-up questionnaires at 2, 4, 6, 8, 12, 16, and 24 weeks to track pain during sport activity and other outcomes. Secondary measures include time to pain onset and duration, pain character, foot paresthesias, self-reported ankle instability, ankle dorsiflexion/eversion strength, and SANE score.
Why it matters
Potential benefit: If successful, injections could offer a non-surgical way to reduce exercise pain and improve leg function for people with anterolateral CECS.
How similar studies have gone: Only case reports and small series have reported symptom improvement with intramuscular botulinum injections, and randomized controlled evidence is currently limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed diagnosis of lower leg anterolateral chronic exertional compartment syndrome (CECS), as measured post-exertional compartment pressure measurements of greater than 30 mmHg for immediate post-exertional compartment pressure, and greater than 12 mmHg at 5 minutes after stopping exercise. Exclusion Criteria: * Female patients who are pregnant, trying to get pregnant or lactating * History of keloidal scarring * History of any significant neurologic disease (ie: amyotrophic lateral sclerosis, motor neuropathy, myasthenia gravis, Lambert-Eaton syndrome)
Where it's running
-
University of Calgary Sport Medicine Centre
Calgary, Alberta, Canada Recruiting
Study contacts
- Principal investigator: Victor Lun — University of Calgary Sport Medicine Centre
- Study coordinator: Victor Lun, MD
- Email: vmylun@ucalgary.ca
- Phone: 403-220-8518
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.