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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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Ultrasound-guided pulsed radiofrequency
|
Ultrasound-guided pulsed radiofrequency will be applied to radicular branch of suprascapular, axillary and lat pectoral nerves
|
|
Experimenteel: Ultrasound-guided phenol neurolysis
|
Ultrasound-guided phenol injection will be applied to radicular branch of suprascapular, axillary and lat pectoral nerves
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in shoulder pain intensity measured from baseline to 3 months
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Pain intensity by VAS at 1 week, 1 month, and 6 months.
Tijdsspanne: 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
Tijdsspanne: 6 months
|
6 months
|
|
|
Functional outcomes using SPADI.
Tijdsspanne: 6 months
|
6 months
|
|
|
Neuromuscular/shoulder ultrasound findings, including bursitis, tendinopathy, effusion, subluxation or other relevant pathology when assessed.
Tijdsspanne: 6 months
|
6 months
|
|
|
Technical success
Tijdsspanne: 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.
Tijdsspanne: 6 months
|
6 months
|
|
|
Shoulder ROM measured by goniometer using a standardized method and side-positioning protocol. [14
Tijdsspanne: 6 months
|
6 months
|
|
|
Shoulder spasticity using MAS, with predefined target muscle groups documented at baseline. [12]
Tijdsspanne: 6 months
|
6 months
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
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Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
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Eerst geplaatst (Werkelijk)
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Laatste update ingediend die voldeed aan QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- ASU-HSP-PRF-PHENOL-1
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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