RecruitingPhase 4NCT07803276

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


Sponsor

Universidade Federal Fluminense

Enrollment

40 participants

Start Date

Apr 22, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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 blinded to muscle ultrasound features (e.g., fatty infiltration or fibrosis) during the landmark-guided phase. Both the participants and the outcome assessor are blinded to the application sequence. Assessments will occur before and 4 weeks after each intervention using validated tools, including the Modified Ashworth Scale, Goal Attainment Scaling (GAS), Timed Up and Go (TUG), Visual Analog Scale (VAS) for pain, modified Barthel Index, SF-36 questionnaire, and the Heckmatt scale. The hypothesis is that ultrasound-guided injections will achieve greater spasticity reduction and functional recovery.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AbobotulinumtoxinA - Conventional Technique and a drug called AbobotulinumtoxinA - Ultrasound-Guided Technique for people with spastic paraplegia. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAbobotulinumtoxinA - Ultrasound-Guided Technique

Administration of AbobotulinumtoxinA (500U) into spastic lower limb target muscles under real-time ultrasound guidance to ensure precise muscle localization. Performed 16 weeks after the first intervention. Assessments are performed pre-injection and 4 weeks post-injection

DRUGAbobotulinumtoxinA - Conventional Technique

Administration of AbobotulinumtoxinA (500U) into spastic lower limb target muscles using standard anatomical landmarks and manual palpation. Assessments are performed at baseline and 4 weeks post-injection.


Locations(1)

Instituto de Neurologia Deolindo Couto

Rio de Janeiro, Rio de Janeiro, Brazil

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NCT07803276


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