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

2026年8月6日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

70

段階

  • 適用できない

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

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

いいえ

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

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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

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出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2027年9月1日

研究の完了 (推定)

2028年2月1日

試験登録日

最初に提出

2026年7月30日

QC基準を満たした最初の提出物

2026年8月6日

最初の投稿 (実際)

2026年8月7日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月7日

QC基準を満たした最後の更新が送信されました

2026年8月6日

最終確認日

2026年8月1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

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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