Chronic Exertional Compartment Syndrome (CECS) Treated With Abobotulinumtoxin A
Purpose
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.
Condition
- Compartment Syndrome of Leg
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment Group |
AbobotulinumtoxinA |
|
|
Placebo Comparator Control Group |
Normal Saline |
|
Recruiting Locations
Atlanta, Georgia 30338
Brookhaven, Georgia 30329
More Details
- NCT ID
- NCT05466539
- Status
- Recruiting
- Sponsor
- Emory University
Detailed Description
Chronic exertional compartment syndrome (CECS) is an underdiagnosed condition and a cause of lower extremity pain often observed in running athletes. In runners, CECS is characterized by a reversible increase in pressure within an inelastic fascial compartment(s) of the lower extremity leading to compromised tissue perfusion and subsequent pain and neurologic symptoms. It impacts both pediatric and adult populations. As currently diagnosed and treated, chronic exertional compartment syndrome presents unique challenges. Evaluation of CECS includes a thorough history and physical exam to rule out other causes of exertional leg pain, but the differential diagnosis must remain high on the list. Needle manometry, an invasive and painful procedure, is therefore used to confirm the diagnosis of CECS by measuring intra-compartmental pressure (ICP). A growing literature, however, positions ultrasound shear wave elastography (SWE) as a viable and attractive alternative to ICP testing as it is both non-invasive and cost-effective. Earlier efforts demonstrated that muscle compartment "hardness" may accurately, and, noninvasively predict ICP. Building on these, SWE now provides direct measures of related mechanical properties of muscle and compartment, namely, "stiffness", thereby demonstrating promise as a diagnostic tool for CECS. Fasciotomy, currently the most well-accepted treatment approach, still has a significant number of treatment failures, demonstrating the need for additional options. A series of case reports have highlighted the potential merits of botulinum toxin as an alternative non-invasive treatment to surgery. Further, there is a growing consensus that desired BoNT targeting is best achieved through incorporating ultrasound guidance during the injection. The largest case series study to date reported that 15/16 patients with CECS had complete exertional pain relief with aboBoNTA. However, the apparent high dosing also led to a reduction in strength in 11/16 patients - An average of 288 units for the anterior compartment and 180 for the lateral compartment. In sum, the optimal dosage has yet to be determined. Recently the research team reported a case of a 39-year-old female runner presenting with lower extremity pain. CECS was confirmed with ICP. In addition, SWE was utilized in diagnosis and management. Briefly, SWE testing showed post-exercise increases in "stiffness" in the right Tibialis Anterior and left Fibularis Brevis relative to baseline measures. To provide perspective, both pre-and post-exercise SWE measures were elevated in this patient compared to two age and sex-matched controls. Following onaBoNTA treatment, further SWE measures revealed a reduction in patient muscle stiffness from the initial pre- post-exercise treadmill testing, reaching levels comparable to the two-asymptomatic age and sex-matched controls by week 6. Collectively, these results support a relationship between changes in intra-compartmental pressure as measured by needle manometry and muscle compartment "stiffness" as measured by SWE, and, as such, a role for SWE in CECS diagnosis and management. In sum, SWE-based diagnosis coupled with ultrasound-enhanced injection accuracy are introduced to potentially complement and/or replace traditional approaches which have challenged the diagnosis and management of CECS.