Effects of Additional High-Intensity Pulsed Electromagnetic Field (HI-PEMF) Therapy on Pain and Physical Function After Total Hip Replacement: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
研究概览
简要总结
This study aims to verify whether high-intensity pulsed electromagnetic fields (HI-PEMF) can be effectively applied to postoperative total hip arthroplasty patients. Using pain and function as the primary assessment indicators, the study explores the effects of HI-PEMF on postoperative total hip arthroplasty to confirm its effectiveness in relieving pain and improving daily living functions. Simultaneously, it combines physical therapy with exercise training to simulate a clinical environment, comprehensively understanding the feasibility of future clinical applications of magnetic field therapy. It is hoped that by exploring the potential benefits of magnetic field intervention in improving the postoperative condition of these high-needs patients, new clinical evidence can be provided for postoperative management.
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A. Age 18 years or older.
- •B. Patients who have undergone primary unilateral total hip arthroplasty due to hip osteoarthritis.
- •C. Patients who, after postoperative evaluation by their surgeon, are advised to bear full weight within their tolerance.
排除标准
- •A. Patients who have not undergone primary hip arthroplasty.
- •B. Patients who are advised by their doctor to maintain non-weight-bearing or partial weight-bearing on the affected or unaffected side.
- •C. History of neurological deficits (e.g., sensory abnormalities, stroke, spinal cord injury, Parkinson's disease, multiple sclerosis).
- •D. Mini-Mental State Examination (MMSE) < 24 (mild cognitive impairment).
- •E. Berger's Balance Scale (BBS) < 40 (higher risk of falls).
- •F. Sensory abnormalities.
- •G. Before or after this exercise training, if pain in other areas (e.g., degenerative pain in the knee or spine) prevents movement, or if the hip joint still experiences pain on a Visual Analogue Scale (VAS) score of 4 or higher even after taking pain medication.
- •H. Known malignancy.
- •I. Schizophrenia, bipolar disorder, or substance addiction (e.g., alcohol, drug).
- •J. Pregnant woman.
- •K. Individuals with implanted stents, pacemakers, or those requiring treatment for arrhythmia.
- •L. Wearing a hearing aid.
研究组 & 干预措施
Arm 1:HI-PEMF
HI-PEMF
干预措施: High-Intensity Pulsed Electromagnetic Field（HI-PEMF) (Device)
Arm 1:HI-PEMF
HI-PEMF
干预措施: Post Operative exercise (Other)
Arm 2 :exercise
干预措施: Post Operative exercise (Other)
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
时间窗: 1-month
This scale can measure THR patient pain and function.The standard WOMAC scale (using a 0-4 Likert scale for each of the 24 questions) ranges from 0 to 96.
次要结局
未报告次要终点