- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Ultrasound-guided pulsed radiofrequency
|
Ultrasound-guided pulsed radiofrequency will be applied to radicular branch of suprascapular, axillary and lat pectoral nerves
|
|
Eksperimentell: Ultrasound-guided phenol neurolysis
|
Ultrasound-guided phenol injection will be applied to radicular branch of suprascapular, axillary and lat pectoral nerves
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in shoulder pain intensity measured from baseline to 3 months
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain intensity by VAS at 1 week, 1 month, and 6 months.
Tidsramme: 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
Tidsramme: 6 months
|
6 months
|
|
|
Functional outcomes using SPADI.
Tidsramme: 6 months
|
6 months
|
|
|
Neuromuscular/shoulder ultrasound findings, including bursitis, tendinopathy, effusion, subluxation or other relevant pathology when assessed.
Tidsramme: 6 months
|
6 months
|
|
|
Technical success
Tidsramme: 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.
Tidsramme: 6 months
|
6 months
|
|
|
Shoulder ROM measured by goniometer using a standardized method and side-positioning protocol. [14
Tidsramme: 6 months
|
6 months
|
|
|
Shoulder spasticity using MAS, with predefined target muscle groups documented at baseline. [12]
Tidsramme: 6 months
|
6 months
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- ASU-HSP-PRF-PHENOL-1
Legemiddel- og utstyrsinformasjon, studiedokumenter
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