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Effectiveness of High-intensity Peripheral Magnetic Stimulation on Hemiplegic Shoulder Pain After Stroke

Effectiveness of High-intensity Peripheral Magnetic Mtimulation in Patients With Post-stroke Hemiplegic Shoulder Pain

This study aims to investigate the effectiveness of high-intensity electromagnetic stimulation using the BTL-6000 Super Inductive System (SIS) in the management of hemiplegic shoulder pain in patients with stroke. Hemiplegic shoulder pain is a common complication following stroke and may negatively affect upper limb function, participation in rehabilitation, and quality of life. The study will evaluate whether treatment with the Super Inductive System can reduce shoulder pain and improve shoulder-related clinical outcomes. The findings are expected to contribute to the evidence regarding non-invasive physical therapy approaches for hemiplegic shoulder pain.

研究概览

研究类型

介入性

注册 (估计的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adults aged 18-75 years.
  • History of a first-ever unilateral stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI), occurring more than 3 months before enrollment.
  • Hemiplegic shoulder pain with a Visual Analog Scale (VAS) score of at least 4.
  • Presence of shoulder pathology identified by clinical examination and ultrasonography.
  • Reduced shoulder range of motion.
  • Brunnstrom recovery stage of at least 2.
  • Clinically stable condition.
  • Mini-Mental State Examination (MMSE) score of at least 18.
  • Ability to provide written informed consent.

Exclusion Criteria:

  • Shoulder pain or restricted shoulder movement before the stroke.
  • History of shoulder trauma, infection, malignancy, or surgery.
  • Full-thickness rotator cuff tear.
  • Shoulder injection within the previous 3 months.
  • Previous treatment with high-intensity laser therapy, electromagnetic stimulation, or therapeutic ultrasound.
  • Central post-stroke pain or complex regional pain syndrome.
  • Modified Ashworth Scale (MAS) score of 3 or higher.
  • Cervical radiculopathy or another neurological disorder.
  • Inflammatory rheumatic disease.
  • Uncontrolled diabetes mellitus (HbA1c of 8% or higher or poor glycemic regulation within the previous 3 months).
  • Pacemaker, implanted electronic device, or metallic implant contraindicating electromagnetic stimulation.
  • Pregnancy.
  • Severe aphasia or severe visual or hearing impairment.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Active Peripheral Magnetic Stimulation

Participants assigned to this group will receive active peripheral magnetic stimulation according to the predefined treatment protocol. The intervention will be administered using the study device under the supervision of trained healthcare professionals.

Participants in the active intervention group will receive active peripheral magnetic stimulation for hemiplegic shoulder pain following stroke. Treatment will be administered using the study device by trained healthcare professionals according to the predefined treatment protocol.

假比较器:Sham Peripheral Magnetic Stimulation

Participants assigned to this group will receive sham peripheral magnetic stimulation using a procedure designed to mimic the active intervention without delivering the intended therapeutic magnetic stimulation. The intervention schedule and assessment procedures will be consistent with those of the active stimulation group.

Participants in the sham comparator group will receive sham peripheral magnetic stimulation for hemiplegic shoulder pain following stroke. The sham procedure will be designed to mimic the active intervention without delivering therapeutic magnetic stimulation. The treatment schedule and assessment procedures will be consistent with those of the active stimulation group.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Visual Analog Scale (VAS) for Shoulder Pain
大体时间:Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)

Shoulder pain will be assessed using the Visual Analog Scale (VAS). Patients will be asked to rate their average shoulder pain experienced at rest and during shoulder movements over the previous 24 hours on a scale from 0 (no pain) to 10 (unbearable pain).

Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)

次要结果测量

结果测量
措施说明
大体时间
Goniometric Measurement of Shoulder Range of Motion
大体时间:Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)

Passive range of motion of the affected shoulder will be measured using a goniometer. Flexion, abduction, internal rotation, and external rotation will be recorded in degrees.

Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
Shoulder Pain and Disability Index (SPADI)
大体时间:Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)

Shoulder pain and functional limitations will be assessed using the Shoulder Pain and Disability Index (SPADI). The scale consists of 13 items covering pain (5 items) and disability (8 items). Scores range from 0 to 100, with higher scores indicating greater pain and disability.

Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
Functional Independence Measure (FIM)
大体时间:Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)

Functional independence will be assessed using the Functional Independence Measure (FIM). The scale consists of 18 items evaluating self-care, transfers, locomotion, sphincter control, communication, and social cognition. Each item is scored from 1 (total dependence) to 7 (complete independence). Total scores range from 18 to 126, with higher scores indicating greater functional independence.

Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
Fugl-Meyer Assessment - Upper Extremity Motor Subscale (FMA-UE)
大体时间:Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)

Upper extremity motor function will be assessed using the Fugl-Meyer Assessment Upper Extremity Motor Subscale (FMA-UE), which evaluates motor function, coordination, and reflex activity in the affected upper extremity. The motor subscale ranges from 0 to 66 points, with higher scores indicating better motor function.

Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
Modified Ashworth Scale (MAS) for Shoulder Spasticity
大体时间:Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)

Shoulder spasticity will be assessed using the Modified Ashworth Scale (MAS), focusing on shoulder adduction and internal rotation patterns rather than individual muscle isolation. The functional contributions of the subscapularis, pectoralis major, latissimus dorsi, and teres major muscles will be considered. Assessments will be performed with patients in a seated position, with the scapula stabilized. Standardized rapid passive movements will be applied, and resistance to movement will be graded according to MAS criteria (0, 1, 1+, 2, 3, and 4), with higher grades indicating greater muscle tone.

Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)
Shoulder Ultrasonographic Findings
大体时间:Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)

Shoulder ultrasonography will be performed using a 5-12 MHz linear transducer. The acromioclavicular joint, glenohumeral joint, long head of the biceps tendon, rotator cuff tendons (supraspinatus, infraspinatus, and subscapularis), and subacromial-subdeltoid bursa will be evaluated. Acromioclavicular joint abnormalities, glenohumeral subluxation, biceps tendon pathology, bursitis, and rotator cuff tendinopathy will be recorded as present or absent. In patients with partial-thickness rotator cuff tears, the maximum anteroposterior tear diameter will be measured in millimeters. Patients with full-thickness rotator cuff tears will be excluded. Copy

Baseline and immediately after completion of 10 treatment sessions (approximately 4 weeks)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2027年8月1日

研究完成 (估计的)

2027年8月1日

研究注册日期

首次提交

2026年10月21日

首先提交符合 QC 标准的

2026年10月30日

首次发布 (实际的)

2026年11月3日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年10月30日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • E2-26-15492

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be shared with other researchers due to participant confidentiality and data privacy considerations.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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