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Comparison Between Palpatory and Ultrasound-guided Methods for Botulinum Toxin Administration in Spastic Paraplegia

RecruitingPhase 4Ages 18 Years - anyAllUniversidade Federal Fluminense
NCT07803276 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Spasticity in spastic paraplegia is a major cause of chronic pain and functional limitation. Although botulinum toxin type A (BoNT-A) reduces muscle tone, studies like the SPASTOX trial have shown limited functional improvement, which may be related to injection accuracy in deep or complex muscle groups. Ultrasound guidance enhances injection precision, potentially improving clinical outcomes. This prospective, single-group, fixed-sequence crossover study ($N = 40$) aims to compare the response to BoNT-A in patients with spastic paraplegia (all etiologies included). Participants will receive treatment in two distinct phases separated by a 16-week washout period: first with conventional anatomical landmark-guided injections, followed by ultrasound-guided injections. A fixed sequence (anatomical first, ultrasound second) is used to prevent observer bias, ensuring the injector remains blind

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📋 Eligibility rules (as published)
Inclusion Criteria * Age over 18 years * Clinical diagnosis of spastic paraplegia * Spasticity with Ashworth Scale score between 2 and 3 in at least one muscle group with indication for botulinum toxin treatment * Muscle strength ≥ 3 on the Muscle Strength Assessment Scale * Enrollment in a rehabilitation program * For women of childbearing potential, a negative beta-hCG test at the time of injection Exclusion Criteria * Concomitant neuromuscular disorders * History of hypersensitivity to botulinum toxin * Active infection at the injection site * Ashworth Scale score of 4 * Pregnancy or breastfeeding
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What it tests

  • AbobotulinumtoxinA - Ultrasound-Guided Technique
  • AbobotulinumtoxinA - Conventional Technique
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Where

1 site
Instituto de Neurologia Deolindo Couto
Rio de Janeiro, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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