Chronic Exertional Compartment Syndrome (CECS) Treated With Abobotulinumtoxin A

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emory University
• Collaborator: Ipsen
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A

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