Comparison Between Radiofrequency and Ultrasound on Shoulder Pain, Range of Motion, and Functional Outcomes in Patients With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Digital Goniometer for shoulder range of motion
研究概览
简要总结
The purpose of the current study is to:
Compare between radiofrequency (TECAR) therapy and ultrasound on Shoulder Pain, Range of Motion and Functional Outcome in Patients with stroke.
详细描述
Stroke is the third leading cause of death worldwide and a major contributor to long-term disability, particularly affecting upper limb function in about 70% of survivors. Among post-stroke complications, hemiplegic shoulder pain (HSP) is notably challenging, affecting 30-65% of patients and often resulting from structural injuries, poor posture, or conditions like rotator cuff impingement and shoulder-hand syndrome. HSP is linked to reduced arm function, depression, and diminished quality of life. Therapeutic approaches such as TECAR therapy and therapeutic ultrasound aim to alleviate pain and promote tissue healing through deep heat and mechanical effects. Assessment tools like the algometer, Numerical Rating Scale (NRS), digital goniometer, and the Shoulder Pain and Disability Index (SPADI)-including its validated Arabic version-are reliable methods for evaluating pain, joint mobility, and functional disability in stroke patients.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fourty-five hemiplegic patients with shoulder pain post- stroke from both sexes will participate in this study.
- •The patients will be older than 18 years old (30-60 years old)
- •The presence of sub-acute shoulder pain (more than 3 months).
- •Sub-acute stroke survivors (3 months post-stroke).
- •score of 1|1+ points on the Modified Ashworth Scale (MAS) on shoulder joint.
- •Stage 2 or above according to Brunnstrom function assessment of shoulder joint
- •All conducted patients experienced a single stroke during the last 3 months with cognitive capacity that will enable them to comprehend and follow the instructions (Mini-Mental Scale score > 24).
排除标准
- •The following patients will be excluded from the study patients with:
- •Bilateral adhesive capsulitis
- •Systemic diseases such as rheumatoid arthritis, malignancies, heart diseases, infections, coagulation disorders, full rotator cuff tears
- •A history of recent shoulder surgery, neurological problems involving the upper extremity, shoulder joint osteoarthritis
- •Upper extremity fractures, cervical radiculopathy
- •Impaired sensation, having a heart pacemaker, pregnancy
- •Injuries in the upper limbs
- •Other neurological diseases or cancer
- •Osteosynthesis material or pacemaker
- •Botulinum toxin or antispastic treatment 3 months prior to studying.
- •Any contraindication to massage and Tecar as skin infections, inflammatory vascular diseases, or acute inflammation.
研究组 & 干预措施
Group (GI)= 15 will be treated by Radiofrequency TECAR Therapy
Group (GI) will be treated by Radiofrequency TECAR Therapy on shoulder joint as well as Designed Physical Therapy Program
干预措施: Radiofrequency (Device)
Group (GII)= 15 will be treated by Ultrasound Therapy
Group (GII) will be treated by Ultrasound Therapy on shoulder joint as well as Designed Physical Therapy Program
干预措施: Ultrasound (Device)
Group (GIII)= 15 will be treated by Designed Physical Therapy Program,
Group (GIII) will be treated by Designed Physical Therapy Program, all outcomes' measures will be assessed pre and post treatment.
干预措施: The designed physical therapy program (Other)
结局指标
主要结局
Digital Goniometer for shoulder range of motion
时间窗: 4 Weeks
The digital goniometer (Baseline 12-1027 USA) will be used to assess range of motion (ROM) of the shoulder joint. The device consists of fixed arm, movable arm and screen. The device converts the angular displacement of the joint (represented in the degree of change of the angle between the two arms of the device) into an electric signal readout which is produced in a simple digital form. The device is the most accurate and objective method of ROM measurement with excellent inter-rater and intra-rater ranged from 0.89 to 0.98
The pressure algometer
时间窗: 4 weeks
The pressure algometer, specifically the hand-held Baseline® model, is a reliable and valid tool used to objectively measure pressure pain thresholds (PPT). It features a pistol-style grip and a pressure-sensitive gauge with a 0.785 cm² rubber tip. The device applies gradual, consistent manual force to determine the minimal pressure at which a sensation of pressure turns into pain. This method is widely used in clinical settings due to its strong correlation with pain intensity and excellent inter-rater reliability, making it a dependable tool for assessing pain sensitivity.
Numerical Rating Scale (NRS):
时间窗: 4 weeks
Numerical Rating Scale (NRS): For pain Threshold will be assessed by Numeric pain rating scale (NPRS) is an 11-point (0-10) Scale will be used to measure pain. Patients verbally will select value between (0-10) based on intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline
Functional Outcome and disability / Shoulder pain and Disability Index (SPADI)
时间窗: 4 weeks
The Shoulder Pain and Disability Index (SPADI) is a 13-item questionnaire used to assess the intensity of shoulder pain and the degree of functional disability. It includes two subscales: five questions evaluating pain severity and eight questions assessing difficulty with daily activities involving upper limb use. Patients mark their responses on a 10 cm visual analogue scale, with scores ranging up to 50 for pain, 80 for disability, and a total of 130, all expressed as percentages. SPADI has demonstrated strong validity and reliability, including in its Arabic version, with an intra-rater reliability coefficient of 0.89, making it a dependable tool for clinical and research use.
次要结局
未报告次要终点
研究者
Rewan Magdy Aloush
Demonestrator for Physical Therapy for Neurology and Its Surgery
Delta University for Science and Technology