Ultrasound-Guided Pulsed Radiofrequency Neuromodulation Versus Ultrasound -Guided Phenol Neurolysis in Post-Stroke Hemiplegic Shoulder Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Change in shoulder pain intensity measured from baseline to 3 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 >=
- •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
排除标准
- •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.
研究组 & 干预措施
Ultrasound-guided pulsed radiofrequency
干预措施: Pulsed radiofrequency neuromodulation (Procedure)
Ultrasound-guided phenol neurolysis
干预措施: Ultrasound-guided phenol neurolysis (Other)
结局指标
主要结局
Change in shoulder pain intensity measured from baseline to 3 months
时间窗: 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.
次要结局
- 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(6 months)
- Functional outcomes using SPADI.(6 months)
- Neuromuscular/shoulder ultrasound findings, including bursitis, tendinopathy, effusion, subluxation or other relevant pathology when assessed.(6 months)
- Technical success(6 months)
- Analgesic/rescue medication consumption during follow-up.(6 months)
- Shoulder ROM measured by goniometer using a standardized method and side-positioning protocol. [14(6 months)
- Shoulder spasticity using MAS, with predefined target muscle groups documented at baseline. [12](6 months)
研究者
Salwa Omar Mohamed
Assistant Lecturer in rheumatology, rehabilitation and physical medicine
Assiut University
