NCT07440173Not yet recruitingPhase 4
Phenol and Botulinum Toxin vs Botulinum Toxin Alone for Post-Stroke Upper-Limb Spasticity
Combined Phenol and Botulinum Toxin vs Botulinum Toxin Alone for Upper-Limb Spasticity After Stroke: A Randomized Trial
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 20 Feb 2026
- Start date
- 1 May 2026
- Primary completion date
- 30 May 2027
- Lead sponsor
- Assiut University
- Diseases
- Stroke
- NCT number
- NCT07440173
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 60
- From 1 May 2026 to the primary completion date, 30 May 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Inclusion criteria :
- 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.
- Cognitive Ability: Ability to understand and follow instructions (Mini-Mental State Examination score typically 24) to ensure cooperation during TMS and functional testing.
- Consent: Signed informed consent provided by the patient or a legal guardian.
- Exclusion Criteria :
- 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).
- Cardiac pacemakers or implanted medication pumps.
- Local Factors:Skin infection or inflammation at the planned injection sites.
- Medical Co-morbidities: Significant peripheral nerve disease (other than the stroke-related upper motor neuron lesion) or severe psychiatric disorders.
- Phenol Sensitivity: Known hypersensitivity to phenol or its derivatives.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.