- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07753759
Ultrasound-Guided Pulsed Radiofrequency Versus Phenol Neurolysis for Post-Stroke Hemiplegic Shoulder Pain
Ultrasound-Guided Pulsed Radiofrequency Neuromodulation Versus Ultrasound -Guided Phenol Neurolysis in Post-Stroke Hemiplegic Shoulder Pain: A Randomized Controlled Trial
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Adults aged 18 years or older. History of ischemic or hemorrhagic stroke confirmed clinically and/or by neuroimaging when available.
Post-stroke shoulder pain on the hemiplegic side with VAS pain intensity >=4/10 during rest, passive movement or functional use.
Spasticity of target shoulder-girdle muscles with MAS score >=2. Stable medical condition allowing outpatient or inpatient interventional procedure.
Ability to provide written informed consent; if the patient has a communication impairment, consent will follow institutional ethics-approved procedures involving legally authorized representatives when appropriate.
Expected ability to attend scheduled follow-up visits through 6 months
Exclusion Criteria:
- Previous radiofrequency treatment or phenol neurolysis to the affected shoulder within the previous 6 months.
Botulinum toxin injection to the target shoulder muscles within the previous 3-6 months.
Shoulder fracture, dislocation or rotator cuff tear requiring surgery. Active infection at the injection site. Known allergy or contraindication to phenol, local anesthetic, antiseptic solution or other procedure-related medication.
Coagulopathy, platelet disorder or anticoagulant/antiplatelet treatment that cannot be safely managed according to local anesthesia/interventional-pain policy.
Severe uncontrolled medical illness, unstable cardiopulmonary disease, uncontrolled diabetes with active infection risk, or any condition judged by investigators to increase procedural risk.
Severe cognitive, behavioral, or communication impairment preventing reliable pain/outcome assessment unless a validated caregiver-assisted assessment approach is approved by the ethics committee.
Pregnancy or lactation, when applicable, because of procedural medication exposure and safety monitoring requirements.
Concurrent participation in another interventional trial that may affect shoulder pain, tone or function.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Ultrasound-guided pulsed radiofrequency
|
Ultrasound-guided pulsed radiofrequency will be applied to radicular branch of suprascapular, axillary and lat pectoral nerves
|
|
Sperimentale: Ultrasound-guided phenol neurolysis
|
Ultrasound-guided phenol injection will be applied to radicular branch of suprascapular, axillary and lat pectoral nerves
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in shoulder pain intensity measured from baseline to 3 months
Lasso di tempo: 3months
|
Change in shoulder pain intensity measured by 0-10 cm/point VAS from baseline to 3 months.
The 3-month endpoint is selected as the primary endpoint because it is clinically meaningful for rehabilitation planning and allows comparison of medium-term response between neuromodulatory PRF and neurolytic phenol treatment.
|
3months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pain intensity by VAS at 1 week, 1 month, and 6 months.
Lasso di tempo: 6 months
|
Pain intensity by VAS at 1 week, 1 month, and 6 months.
|
6 months
|
|
Patient Global Impression of Change (1-7)at 1, 3, and 6 month
Lasso di tempo: 6 months
|
6 months
|
|
|
Functional outcomes using SPADI.
Lasso di tempo: 6 months
|
6 months
|
|
|
Neuromuscular/shoulder ultrasound findings, including bursitis, tendinopathy, effusion, subluxation or other relevant pathology when assessed.
Lasso di tempo: 6 months
|
6 months
|
|
|
Technical success
Lasso di tempo: 6 months
|
Technical success is defined as successful ultrasound-guided identification of all predefined target nerves, correct needle placement, and complete delivery of the assigned intervention to all target nerves.
The outcome will be reported as the proportion of participants in whom all criteria are achieved
|
6 months
|
|
Analgesic/rescue medication consumption during follow-up.
Lasso di tempo: 6 months
|
6 months
|
|
|
Shoulder ROM measured by goniometer using a standardized method and side-positioning protocol. [14
Lasso di tempo: 6 months
|
6 months
|
|
|
Shoulder spasticity using MAS, with predefined target muscle groups documented at baseline. [12]
Lasso di tempo: 6 months
|
6 months
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- Park D, Chang MC. The mechanism of action of pulsed radiofrequency in reducing pain: a narrative review. J Yeungnam Med Sci. 2022 Jul;39(3):200-205. doi: 10.12701/jyms.2022.00101. Epub 2022 Apr 7.
- Karri J, Mas MF, Francisco GE, Li S. Practice patterns for spasticity management with phenol neurolysis. J Rehabil Med. 2017 Jun 28;49(6):482-488. doi: 10.2340/16501977-2239.
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Guideline: Guideline for Good Clinical Practice E6(R3). Final version. Adopted 06 January 2025.
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- ASU-HSP-PRF-PHENOL-1
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .