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
調査の概要
状態
詳細な説明
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Ultrasound-guided pulsed radiofrequency
|
Ultrasound-guided pulsed radiofrequency will be applied to radicular branch of suprascapular, axillary and lat pectoral nerves
|
|
実験的:Ultrasound-guided phenol neurolysis
|
Ultrasound-guided phenol injection will be applied to radicular branch of suprascapular, axillary and lat pectoral nerves
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in shoulder pain intensity measured from baseline to 3 months
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain intensity by VAS at 1 week, 1 month, and 6 months.
時間枠: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
時間枠:6 months
|
6 months
|
|
|
Functional outcomes using SPADI.
時間枠:6 months
|
6 months
|
|
|
Neuromuscular/shoulder ultrasound findings, including bursitis, tendinopathy, effusion, subluxation or other relevant pathology when assessed.
時間枠:6 months
|
6 months
|
|
|
Technical success
時間枠: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.
時間枠:6 months
|
6 months
|
|
|
Shoulder ROM measured by goniometer using a standardized method and side-positioning protocol. [14
時間枠:6 months
|
6 months
|
|
|
Shoulder spasticity using MAS, with predefined target muscle groups documented at baseline. [12]
時間枠:6 months
|
6 months
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- ASU-HSP-PRF-PHENOL-1
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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