A Double-Blinded, Randomized-Control-Trial to Investigate the Effect of Pulsed Electromagnetic Field (PEMF) for Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change of Peak torque of Isometric muscle strength
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). OA is a debilitating progressive disease with typical symptoms such as acute pain causing loss of mobility Currently there is no cure for OA. Pharmacological treatment and new regenerative technologies such as stem cell therapy are actively being developed, but most of these options are very expensive per se, and side effects are not uncommon. Costeffectiveness is also a major consideration for devising new therapeutic modalities for OA.
There are emerging evidences showing that pulsed electromagnetic field (PEMF) can modulae mitochondrial activities for muscle gain. PEMF exposure on top of regular exercise training may promote muscle regeneration and tissue healing.
This study aims to conduct a double-blinded, randomized controlled trial to investigate the effect of PEMF treatment on knee pain in patients with knee OA. We hypothesize that PEMF treatment is effective to relief in pain and improve knee function in Knee OA subjects.
Based on the aim of this study, older adult patients (aged 50 or above) with knee OA with Kellgren-Lawrence grade 2-4 by X-ray, have sedentary lifestyle (Tegner activity level less or equal to 3), no acute knee injuries in past 12 months, no muscle strain in past 12 months and not degenerative joint disease in other joints except the involved knee.
To estimate the improvement of patients, isometric quadricep muscle strength, posture assessment, serum myokine level, serum vitamin D level and selfreported outcome with questionnaires will be performed.
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, Care Provider, Investigator)
盲法说明
It is doubled blinded, a subject 's specific ID card will be provided for each of the enrolled subject and the investigators don't know whether it is PEMF or Sham treatment for that subject's specific ID card. And the investigator will ask the manufactory about the number of grouping at the end of the study.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 50 or above
- •knee OA with Kellgren-Lawrence grade 2-4 by X-ray
- •Sedentary lifestyle (Tegner activity level ≤ 3)
- •No acute knee injuries in past 12 months
- •No muscle strain in past 12 months
- •No degenerative joint diseases in other joints except the involved knee
排除标准
- •Age smaller than 50 years old
- •Experienced any concomitant bone fracture, ACL injury, major meniscus injury
- •Any rheumatological diseases
- •Metal implants that would cause interference on MRI
- •Previous contralateral knee injury
- •Recent knee injections (prior 3 months)
- •Physical inability to undertake testing procedures
- •Pregnancy or possibility of pregnancy
结局指标
主要结局
Change of Peak torque of Isometric muscle strength
时间窗: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
The peak torque in kgf will be recorded with in 2 trials in the 5 seconds isometric muscle strength test.
次要结局
- International Physical Activity Questionnaire(pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF)
- Short Form-36 questionnaires (SF-36)(pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF)
- The speed and rate of force development in 6 repetitions in chair stand test(pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF)
- Change of centre of pressure with the position of double leg squat(pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF)
- Change of centre of pressure with the position of dynamic postural codition(pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF)
- Change of the scoring of Knee injury and Osteoarthritis Outcome Score(pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF)
- Serum myokine evaluation(pre PEMF treatment, 3-months, 6-months, and 12-months after the commencement of PEMF)
- Tegner activity score(pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF)
- Change of centre of pressure with the position of static postural codition(pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF)
- Visual Analogue Scale(pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF)
- Serum vitamin D level and vitamin D metabolites evaluation(pre PEMF treatment, 3-months, 6-months, and 12-months after the commencement of PEMF)
研究者
Prof. Tim-Yun Michael ONG
Clinical Assistant Professor
Chinese University of Hong Kong