Pulsed Electromagnetic Fields (PEMF) in Knee Osteoarthritis: a Double-blind, Placebo-controlled, Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Muscle power
研究概览
简要总结
Health care costs are increasing alarmingly, which will impose an overwhelming economic burden to an aging society like that of Hong Kong. For example, degenerative musculoskeletal disorders such as osteoarthritis (OA) present a grand challenge with its high prevalence (>40% in the elderly suffered from knee OA). Knee osteoarthritis (OA) is the most common form of arthritis, and around 2 million population worldwide suffer from this disorder. OA is a debilitating progressive disease with typical pathological progress such as cartilage degeneration, inflammation, joint width narrowing and developing osteophytes. The main system of knee OA is acute pain leading to loss of mobility. There is no effective treatment to cure or stop the progression of OA. For now, the main method is to alleviate the pain and symptoms, including control weight, exercise, physical treatment and intake of NSAIDs/ paracetamol.
Pulsed electromagnetic field (PEMF) treatment has shown to enhance cell activity related to tissue healing, delay bone and cartilage degeneration and give beneficial effects such as relief in pain, anti-inflammation and reduce swelling. In clinic, PEMF treatment has been reported to be safe, and has been proved to reduce the usage of NSAIDs and pain in patients with knee OA.
This study aims to investigate the effectiveness of PEMF therapy on for patients with knee OA.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary osteoarthritis of knee
- •VAS score ≥ 4
- •Grade 2 and 3 osteoarthritis (Kellgren-Lawrence criteria)
- •No alleviation of symptoms after ≥ 3 months of nonsurgical treatment
- •No acute knee injuries in both limbs in the past 3 months
- •No muscle strain in both limbs in the past 3 months
- •Voluntarily agreed to participate and signed the informed consent form
排除标准
- •Skin diseases around the target knee joint
- •Severe pain in other areas affects the diagnosis of function and symptoms of knee joints
- •Injection in target knee within 3 months of enrolment
- •Inflammatory joint disease (e.g., rheumatic inflammation)
- •Infectious joint disease (e.g., septic arthritis)
- •Pregnant or breastfeeding
- •Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a neurostimulator, cochlear implant, a stent, an insulin pump
- •Physical inability to undertake testing procedures
- •Inability to give informed consent
结局指标
主要结局
Muscle power
时间窗: Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)
The isometric strength of the knee flexors and extensors was measured by a handheld dynamometer (MicroFET2, Hoggan Scientific, United States)
次要结局
- Sonography(Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment))
- Dual-energy X-ray absorptiometry (DXA)(Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment))
- 6-meter timed walking test(Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment))
- 30-second chair stand test(Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment))
- X-ray Radiography(Baseline (pre-treatment), 2 months (immediate post-treatment), and 14 months (12 months post-treatment))
- WOMAC(Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment))
研究者
Pauline Lui
Associate Professor
Chinese University of Hong Kong