Treatment of Chronic Exertional Compartment Syndrome with Botulinum Toxin

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

This study is testing if a botulinum toxin treatment can help runners with Chronic Exertional Compartment Syndrome feel better by reducing muscle pressure and pain.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Emory University (other)
• Locations: 2 sites (Atlanta, Georgia and 1 other locations)
• Trial ID: NCT05466539 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of abobotulinumtoxinA as a treatment for Chronic Exertional Compartment Syndrome (CECS) in runners, a condition characterized by painful increases in pressure within the leg's muscle compartments. The study aims to develop a non-invasive diagnostic method using ultrasound shear wave elastography (SWE) to assess muscle stiffness, potentially replacing the invasive needle manometry currently used. Participants will be randomly assigned to receive either the botulinum toxin or a placebo, with the goal of evaluating the efficacy and safety of this treatment approach. The trial will include adult runners aged 18-65 who meet specific diagnostic criteria for CECS.

Who should consider this trial

Good fit: Ideal candidates for this study are adult runners aged 18-65 who experience significant pain due to CECS and have confirmed elevated intra-compartmental pressure.

Not a fit: Patients with a history of neuromuscular disease, serious soft-tissue injuries, or previous surgeries to the lower limbs may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a less invasive and more effective option for managing CECS, reducing the need for surgery and improving recovery times for athletes.

How similar studies have performed: While the use of botulinum toxin for CECS is relatively novel, there is growing literature supporting the use of SWE for non-invasive diagnosis, indicating potential for success in this approach.

Eligibility criteria

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 \> 15mmHg; 1-min. post \> 30mmHg; or, 5-min. post \> 20mmHg
* Ages 18-65 years inclusive at study onset.
* Ability to adhere to protocol.
* Pain level on the VAS of \>=6/10 during baseline visit assessed immediately after a treadmill run
* An established physiotherapy and/or orthotic regimen will be permitted provided that it began \> 4 weeks before the study start and is maintained throughout the study.
* Botulinum toxin naïve (lower extremity). Others previously treated, \> than 6 mos. prior to 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) \< than12 months prior to study entry.
* Current need for surgery at any level of the lower extremity.Without a history of Neuromuscular disease, serious soft-tissue injury, fractures, and surgery to the lower limb(s).
* 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, pregnant women, prisoners, persons who have not obtained the legal age for consent to treatment or procedures

Where this trial is running

Atlanta, Georgia and 1 other locations

• Emory Sports Medicine-Dunwoody — Atlanta, Georgia, United States (RECRUITING)
• Emory Hawks Sports Medicine Center — Brookhaven, Georgia, United States (RECRUITING)

Study contacts

• Principal investigator: Lee Kneer — Emory University
• Study coordinator: Lee Kneer, MD

Conditions: Compartment Syndrome of Leg, Runners, Lower extremity pain, Exertional Compartment Syndrome of the Leg