Efficacy of High Energy Density Pulse Electromagnetic Field for Patients With Rotator Cuff Tendinopathy: A Double-blinded, Randomized Controlled Trail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in Pain Visual Analogue Scale(VAS)
研究概览
简要总结
The aim of our study is to investigate the efficacy of high energy density pulse electromagnetic field for patients with rotator cuff tendinopathy
详细描述
Traditional pulse electromagnetic field (PEMF) devices have been approved by the U.S. Food and Drug Administration (FDA) to treat nonunion fractures and cleared to treat post-operative pain and edema, osteoarthritis, and plantar fasciitis. However, high level of evidence indicated that the lack of beneficial effects of PEMF on pain, function or range of motion in the treatment of shoulder pain.
High energy density pulse electromagnetic field(High-PEMF) which builds up a voltage up to 30 kilovolt (kV) with shorter impulse time(50us) and broad band-width(200kHz~300MHz) is very different from traditional PEMF. Magnetic field about 50~150 millitesla (mT) is created and it can penetrate the body up to 20 cm. The aim of our study is to investigate the efficacy of High-PEMF for patients with rotator cuff tendinopathy.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 20 to 75 years old
- •persistent shoulder pain for at least 3 months and pain VAS score >=5
- •positive result in any of the following physical examinations: Hawkins-Kennedy, Neer or Jobe tests
- •confirmed rotator cuff tendinopathy by ultrasonography or MRI
排除标准
- •complete or full-thickness tear of rotator cuff found by ultrasonography or MRI
- •previous shoulder surgery
- •previous history of severe trauma in shoulder
- •cervical radiculopathy related shoulder pain or referred pain
- •other shoulder diseases: adhesive capsulitis, calcifying tendinopathy, radiology-confirmed acromion type III, shoulder instability, degenerative osteoarthritis, labral tear
- •present with any of the following systemic diseases: active infection, sever and uncontrolled medical condition, cancer, immune-related or rheumatoid arthritis, hyperuricemia and gout
- •previous treatment with articular or subacromial steroid injections within the last 3 months
- •cognitive impairment with loss of ability to sign the agreement and receive rehabilitation
- •pregnancy or lactating women
- •has any of the following contraindications: Carriers of pacemakers, internal defibrillators,internal metal implants (locally dependent), Cochlea implants, metallic stents, insulin pumps
结局指标
主要结局
Change in Pain Visual Analogue Scale(VAS)
时间窗: baseline, immediate after treatment, 4 weeks, 12 weeks
The Visual Analog Scale (VAS) was used to measure pain intensity. The scale ranges from 0 to 10, where 0 indicates no pain and 10 represents the worst possible pain. Higher scores indicate worse outcomes.
次要结局
- Change in Total Score of Shoulder Pain and Disability Index (SPADI)(baseline, immediate after treatment, 4 weeks, 12 weeks)
- Changes of Shoulder Range of Motion in Active Flexion(baseline, immediate after treatment, 4 weeks, 12 weeks)
- Changes of Shoulder Range of Motion in Active Abduction(baseline, immediately after treatment, 4 weeks, 12 weeks)
- Changes of Shoulder Range of Motion in Active Internal Rotation(baseline, immediately after treatment, 4 weeks, 12 weeks)
研究者
Liang-Cheng Chen
Director
Tri-Service General Hospital