Effectiveness of High-Intensity Laser Therapy Combined With Exercise on Clinical and Ultrasonographic Outcomes in Patients With Hemiplegic Shoulder Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Shoulder Pain and Disability Index (SPADI)
研究概览
简要总结
This randomized, sham-controlled clinical trial aims to evaluate the effectiveness of high-intensity laser therapy (HILT) combined with exercise on pain, functional status, disability, and ultrasonographic findings in patients with hemiplegic shoulder pain following stroke.
详细描述
Hemiplegic shoulder pain (HSP) is a common complication after stroke that significantly affects functional recovery and quality of life. High-intensity laser therapy (HILT) has analgesic, anti-inflammatory, and regenerative effects.
Participants will be randomly assigned into two groups:
HILT + exercise therapy Sham HILT + exercise therapy
The treatment protocol will consist of 20 sessions over 4 weeks (5 sessions per week).
Outcome assessments will be conducted at baseline and at the end of week 4 by blinded assessors.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30-75 years
- •Hemiplegic shoulder pain after stroke
- •Stroke within last 6 months
- •VAS ≥ 3 for pain
- •Medically stable
排除标准
- •Neurological disorders (MS, Parkinson, etc.)
- •Recent shoulder surgery/injection
- •Botulinum toxin (last 6 months)
- •Malignancy
- •Pregnancy
- •Epilepsy or photosensitivity
- •Cognitive impairment
结局指标
主要结局
Shoulder Pain and Disability Index (SPADI)
时间窗: Baseline and Week 4
The Shoulder Pain and Disability Index (SPADI) was used to evaluate shoulder-related pain and functional impairment. The index consists of 13 items divided into two subscales: pain (5 items) and disability (8 items). Each item is scored on a 0-10 numerical rating scale, where 0 indicates "no pain/difficulty" and 10 indicates "worst imaginable pain/so difficult it requires help." The total score is calculated by averaging the subscale scores and converting them to a percentage, ranging from 0 to 100. Higher scores represent greater levels of pain and disability. The SPADI is a widely recognized tool with high internal consistency and responsiveness to clinical changes in shoulder conditions.
Functional Independence Measure (FIM)
时间窗: Baseline and Week 4
Assesses functional independence in activities of daily living. Includes motor and total scores. The functional status of the participants was evaluated using the Functional Independence Measure (FIM). The FIM consists of 18 items, categorized into two main domains: Motor FIM (13 items): Assessing self-care, sphincter control, transfers, and locomotion (score range: 13-91). Cognitive FIM (5 items): Assessing communication and social cognition (score range: 5-35). Each item is scored on a 7-point Likert scale, ranging from 1 (total assistance) to 7 (complete independence). Total scores range from 18 to 126, where higher scores indicate greater functional independence.
Ultrasonographic Assessment
时间窗: Baseline and Week 4
This description refers to the Ultrasonographic Evaluation of the shoulder. In a Method section, it is important to specify that the exam was performed by a specialist and to list the specific structures visualized. Here is the professional English text for your article: Ultrasonographic Evaluation All participants underwent a standardized musculoskeletal ultrasound (US) examination of the affected shoulder, performed by an experienced \[radiologist/physiatrist\] using a \[Insert Brand, e.g., GE Voluson\] system with a high-frequency linear transducer. The examination followed the European Society of Musculoskeletal Radiology (ESSR) guidelines. The sonographic assessment included: Tendon Pathology: Evaluation of the supraspinatus, infraspinatus, and subscapularis tendons for signs of tendinosis, calcifications, and partial or full-thickness tears. The long head of the biceps tendon was also assessed for tenosynovitis or subluxation
次要结局
- Brunnstrom Recovery Stages(Baseline and Week 4)
- Shoulder Range of Motion (ROM)(Baseline and Week 4)
- Modified Ashworth Scale(Baseline and Week 4)
- Pressure Pain Threshold(Baseline and Week 4)
- Acromiohumeral Distance(Baseline and Week 4)
- Supraspinatus Tendon Thickness and occupation ratio(Baseline and Week 4)
研究者
Fatima Yaman
Assoc. Prof.
Kutahya Health Sciences University