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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAssiut University

About this trial

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.

Eligibility criteria

Qualifiers

Adults aged 18 to 70 years.

Diagnosis: Documented Ischemic or Hemorrhagic stroke (with a duration of at least 6 months post-stroke to ensure a chronic, stable phase).

Spasticity Severity: A score of 2 on the Modified Ashworth Scale (MAS) in at least one proximal muscle group (Shoulder adductors or Elbow flexors).

Functional Status: Evidence of upper limb motor impairment but with enough stability to participate in follow-up.

Disqualifiers

Fixed Contractures: Any permanent joint deformity or fixed contracture in the target limb that would prevent range of motion improvement.

Prior Treatment: Received Botulinum Toxin or phenol injections in the affected limb within the last 6 months.

TMS Contraindications: History of seizures.

Presence of metallic implants in the head or neck (e.g., clips, shunts).

Trial design

Treatments tested in this trial

  • phenol neurolysis
  • Botulinum Toxin - A injections

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators