Clinical Trial

Phenol and Botulinum Toxin vs Botulinum Toxin Alone for Post-Stroke Upper-Limb Spasticity

Not Yet Recruiting Phase 4
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Summary
This study aims to evaluate the efficacy of a combined treatment approach for post-stroke upper limb spasticity using phenol neurolysis and botulinum toxin (BoNT). Spasticity is a common post-stroke complication that leads to muscle stiffness and significantly hinders functional recovery. While botulinum toxin is the standard treatment, its high cost often limits its application, particularly for large proximal muscles. The researchers will compare two treatment strategies in 60 adult stroke survivors: Group A (Combined Therapy): Patients will receive ultrasound-guided phenol neurolysis for the proximal nerves (pectoralis and musculocutaneous nerves) and botulinum toxin for the distal forearm flexors. Group B (Standard Care): Patients will receive botulinum toxin alone for all affected muscles in the upper limb. All procedures will be performed under ultrasound guidance to ensure anatomical precision. The study will also utilize Transcranial Magnetic Stimulation (TMS) to assess changes in cortical excitability (RMT, MEPs, and cortical silent period). The primary goal is to determine if this combined approach effectively reduces muscle stiffness (measured by the Modified Ashworth Scale) while potentially reducing the total dose of botulinum toxin required per patient.
Trial Details
NCT Number NCT07440173
Lead Sponsor Assiut University
Conditions Spasticity as Sequela of Stroke
Enrollment 60 participants
Start Date 2026-05-01
Primary Completion 2027-05-30 (estimated)
Study Completion 2027-07-15 (estimated)
Updated on ClinicalTrials.gov 2026-02-27