Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Ultrasound-Guided Pulsed Radiofrequency Versus Phenol Neurolysis for Post-Stroke Hemiplegic Shoulder Pain

6 augustus 2026 bijgewerkt door: Salwa Omar Mohamed, Assiut University

Ultrasound-Guided Pulsed Radiofrequency Neuromodulation Versus Ultrasound -Guided Phenol Neurolysis in Post-Stroke Hemiplegic Shoulder Pain: A Randomized Controlled Trial

Post-stroke hemiplegic shoulder pain is a common complication that negatively affects upper limb function and quality of life. This randomized controlled trial aims to compare the efficacy and safety of ultrasound-guided pulsed radiofrequency neuromodulation versus ultrasound-guided phenol neurolysis targeting the suprascapular, axillary, and lateral pectoral nerves in patients with post-stroke hemiplegic shoulder pain. The primary outcome is pain reduction, while secondary outcomes include shoulder function, spasticity, range of motion, quality of life, analgesic consumption, and adverse events during follow-up.

Studie Overzicht

Gedetailleerde beschrijving

Hemiplegic shoulder pain (HSP) is a common complication following stroke. It may lead to withdrawal from rehabilitation programs, reduced upper-limb movement and poorer functional recovery; therefore, timely pain control is relevant to rehabilitation participation and long-term outcome. [1] A systematic review reported wide variation in incidence and prevalence; pooled/meta-analytic estimates included incidence ranges around 10-22% and prevalence ranges around 22-47%, while individual studies varied more widely because of differences in timing, definitions and clinical settings. Risk factors include increased tone, impaired motor function, sensory impairment, shoulder subluxation, abnormal shoulder examination, hemispastical neglect and prior shoulder pain. [1,2] The cause of post-stroke HSP is often multifactorial. The mechanisms can be grouped into: (a) impaired motor control and tone changes; (b) soft-tissue lesions and (c) altered peripheral and central nervous activity, Because these mechanisms may overlap in the same patient, baseline clinical and ultrasound phenotyping will be used to document the dominant pain/spasticity pattern and to exclude structural shoulder pathology requiring surgical management. [1,3,4] Central sensitization, defined as increased responsiveness of nociceptive neurons in the central nervous system to normal or subthreshold afferent input, may contribute to persistent HSP. [4] Pulsed radiofrequency delivers radiofrequency current in intermittent pulses consisting of short periods of electrical stimulation, typically 20 ms, followed by longer silent phases, approximately 480 ms. This intermittent delivery allows heat dissipation and keeps target tissue temperature below approximately 42 degrees Celsius, thereby reducing the risk of thermal nerve injury. For this reason, the intervention is described in this enhanced protocol as PRF rather than conventional thermal radiofrequency ablation. This correction improves technical accuracy because the submitted synopsis described a PRF technique rather than destructive thermal ablation. [5] PRF stimulation may reduce pain through long-term depression of C-fiber-mediated spinal sensitization and several neuromodulatory effects on inflammatory and descending inhibitory pathways. The exact mechanism remains elucidated; therefore, the study will measure both pain and function rather than assuming a single mechanism of benefit. [5,6] Phenol is a neurolytic agent used to manage focal spasticity. Immediately after injection, phenol may produce a transient local anesthetic effect by reversibly blocking nerve conduction. At neurolytic concentrations, commonly around 5-6%, phenol causes protein denaturation with segmental demyelination, axonal degeneration, and Wallerian degeneration of exposed nerve fibers, interrupting nerve conduction and reducing overactivity. Because phenol can cause dysesthesia, pain, inflammation, hypotension or unintended motor/sensory effects, the protocol specifies ultrasound guidance, aspiration before injection, limited per-nerve volumes according to institutional SOP, post-procedure monitoring, and structured AE recording.

Studietype

Ingrijpend

Inschrijving (Geschat)

70

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

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

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

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

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 september 2027

Studie voltooiing (Geschat)

1 februari 2028

Studieregistratiedata

Eerst ingediend

30 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 augustus 2026

Eerst geplaatst (Werkelijk)

7 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

6 augustus 2026

Laatst geverifieerd

1 augustus 2026

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

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren