Effects of Extracorporeal Shock Wave Therapy on Shoulder Internal Rotator Spasticity in Post-Stroke Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- passive range of motion for the shoulder joints
研究概览
简要总结
Extracorporeal shock wave therapy (ESWT) has shown potential in reducing post-stroke limb spasticity. This study aims to evaluate the efficacy of focused ESWT on shoulder internal rotator spasticity in post-stroke patients.
详细描述
This study aimed to evaluate the effects of focused extracorporeal shock wave therapy (ESWT) on shoulder internal rotator spasticity in stroke patients. Participants were randomized into two groups: an experimental group receiving targeted ESWT on specific shoulder internal rotators, and a control group receiving placebo treatments mimicking the shockwave therapy, with treatments administered twice weekly over two weeks for a total of four sessions.
The efficacy of the treatment was measured using a comprehensive set of assessment tools, including range of motion, pain levels, spasticity scales, functional assessments, as well as measures of daily living activities, and ultrasound strain elastography. The outcomes were evaluated at multiple points in time: before treatment, and 1, 4, 12, and 24 weeks after the therapy concluded, to assess both immediate and sustained effects of the treatment on shoulder function and spasticity in stroke survivors.
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 (Participant)
盲法说明
Participant Care Provider 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
- •Patients aged 18 years or older with unilateral cerebral stroke.
- •Restricted passive external rotation of the spastic shoulder by more than 20 degrees.
- •A Modified Ashworth Scale score of 1 or higher for shoulder internal rotator spasticity.
- •Stable medical condition and vital signs.
- •Clear consciousness, able to follow instructions.
排除标准
- •History of two or more strokes, traumatic brain injury, brain tumors, or other cerebral disorders.
- •Coexisting central nervous system disorders (e.g., spinal cord injury, Parkinson's disease) or other musculoskeletal conditions affecting muscle tone assessment.
- •Ineligibility for shock wave intervention due to malignancies, coagulation disorders, localized infections, or presence of a pacemaker.
- •Prior shock wave intervention or botulinum toxin injection for post-stroke spasticity within the past three months.
- •Inability to participate in interventions or functional assessments due to cognitive, consciousness, or language impairments.
研究组 & 干预措施
Focused Extracorporeal Shock Wave
Participants in this arm will receive focused Extracorporeal Shock Wave Therapy (ESWT) targeting four specific muscles: subscapularis, pectoralis major, latissimus dorsi, and teres major muscles. Each muscle will receive 1,000 shockwave shots per session, accumulating to a total of 4,000 shots across all targeted muscles in each session. The treatment will be administered twice a week for two consecutive weeks, resulting in a total of four treatment sessions.
干预措施: focused extracorporeal shock wave therapy (ESWT) (Device)
Placebo-Controlled Shockwave Therapy
Participants in this arm will receive placebo-controlled focused ESWT, mirroring the treatment protocol of the experimental group but without the application of active shockwaves.
干预措施: focused extracorporeal shock wave therapy (ESWT) (Device)
结局指标
主要结局
passive range of motion for the shoulder joints
时间窗: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
the extent to which a joint can be moved without the patient actively participating in the movement
shoulder strength
时间窗: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
the muscle power generated by the shoulder muscles, quantified using the Medical Research Council (MRC) scale, which grades muscle strength from 0 (no visible contraction) to 5 (normal strength against full resistance)
Visual Analogue Scale (VAS)
时间窗: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
individuals rate their pain from 0 to 10, where 0 represents 'no pain' and 10 signifies 'the worst pain imaginable
modified Ashworth scale (MAS)
时间窗: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Evaluate spasticity in individuals with neurological conditions. The scale ranges from 0, indicating no increase in muscle tone, to 4, which represents severe spasticity with affected parts rigid in flexion or extension.
次要结局
- Fugl-Meyer Assessment for the Upper Extremity (FMA-UE)(pre-treatment; 1, 4, 12, and 24 weeks post-treatment)
- Action Research Arm Test (ARAT)(pre-treatment; 1, 4, 12, and 24 weeks post-treatment)
- Barthel index(pre-treatment; 1, 4, 12, and 24 weeks post-treatment)
- Wolf Motor Function Test(pre-treatment; 1, 4, 12, and 24 weeks post-treatment)
- ultrasound assessment(pre-treatment; 1, 4, 12, and 24 weeks post-treatment)