Botulinum injections for anterolateral lower-leg chronic exertional compartment syndrome
Treatment of Lower Leg Anterolateral Chronic Exertional Compartment Syndrome With Intra-muscular Botulinum Injections.
This will test whether botulinum toxin injections into the lower-leg muscles reduce exercise-related pain in adults with anterolateral CECS.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT05765071 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Only case reports and small series have reported symptom improvement with intramuscular botulinum injections, and randomized controlled evidence is currently limited.
Eligibility criteria
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 this trial is running
Calgary, Alberta
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.