Efficacy of High Energy Density Pulse Electromagnetic Field for Patients With Adhensive Capsulitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 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 adhesive capsulitis
详细描述
Adhesive capsulitis, a condition causing shoulder pain and limited range of motion (ROM), is estimated to affect 2-5% of the general population. Typically occurring in middle-aged individuals during their 50s to 70s, it presents with gradually developing shoulder pain and restricted ROM, particularly in external rotation.
In cases of primary adhesive capsulitis, the condition often resolves on its own, lasting around 18-24 months. However, some individuals experience persistent symptoms beyond 3 years, with up to 40% of patients and 15% facing lasting disability. Therefore, effective treatment is essential to alleviate the pain and disability associated with frozen shoulder.
High energy density pulse electromagnetic field (High-PEMF) differs from traditional PEMF and possesses the following characteristics:
Brief pulse duration (50μs) with a damped oscillation. Wide bandwidth (200kHz~300MHz) centered around 240kHz. High voltages (up to 40 kV) and peak currents (up to 10 kA) in the applicator spool.
Delivery of around 96Ws (Joule) of energy per pulse with a magnetic flux density of 50~100mT.
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
- •Physicians diagnose frozen shoulder by considering the patient's medical background, conducting a physical assessment, and reviewing X-ray and ultrasound findings.
- •The symptoms endure for a duration exceeding 3 months.
- •There exists a decrease of no less than 30 degrees in a minimum of two joint angles of the affected shoulder, namely flexion, abduction, and external rotation, in comparison to the corresponding angles of the unaffected side.
排除标准
- •Musculoskeletal ultrasound of the shoulder identifies a full-thickness tear or substantial tear in the rotator cuff tendons or presents calcific tendinitis.
- •Presence of systemic rheumatic disease.
- •Prior history of shoulder fracture or surgical intervention involving the shoulder joint.
- •Acute compression of cervical nerve root.
- •Patients displaying instability (e.g., those with signs of internal bleeding) or individuals with cancer.
- •Recent receipt of shoulder injections for treatment within the last 3 months.
- •Impaired cognitive function that hinders the patient's ability to provide informed consent or engage in rehabilitation therapy.
- •Expectant or breastfeeding women.
- •Meets any of the contraindications for high-energy electromagnetic pulse therapy: individuals with organ transplants, implanted cardiac pacemakers, defibrillators, metal implants (such as stents), cochlear implants, and those requiring insulin supplementation.
结局指标
主要结局
Change in pain Visual Analogue Scale(VAS)
时间窗: the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months
The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. "0" means painless and "10" means extremely painful.
次要结局
- Change in Shoulder Pain and Disability Index (SPADI)(the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months)
研究者
Liang-Cheng Chen
Director
Tri-Service General Hospital