Effects of Radial Extracorporeal Shock Wave Therapy (r-ESWT) on Clinical Variables and Isokinetic Performance in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- 20-meter walk test
研究概览
简要总结
This study aims to compare the efficacy of r-ESWT treatment with sham-ESWT on pain, walking speed, physical function, and isokinetic muscle strength in knee osteoarthritis.
详细描述
Extracorporeal shock wave therapy (ESWT) has been increasingly used to help relieve pain and to remedy musculoskeletal disorders in recent years. ESWT seems to be an effective treatment modality many different musculoskeletal conditions, including rotator cuff tendinopathies, calcifying tendinopathy of the shoulder, lateral epicondylitis, greater trochanteric pain syndrome, patellar tendinopathy, achilles tendinopathy, plantar fasciitis, and bone disorders. ESWT seems to have chondroprotective, anti-inflammatory, neovascularization, anti-apoptotic, and tissue regeneration effect on tissues which could be relevant in the treatment of 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Knee OA according to American College of Rheumatology (ACR) diagnostic criteria with Kellgren - Lawrence (K-L) grade 2 or 3.
排除标准
- •Patients with secondary OA,
- •severe chronic illness,
- •poor general health status (heart failure, chronic bronchitis, etc.),
- •chronic inflammatory diseases,
- •knee replacement surgery,
- •prior malignancy
研究组 & 干预措施
ESWT group
All patients in both groups were applied with a hot pack for 40-minutes, transcutaneous electrical nerve stimulation for 30-minutes (100 Hz frequency and 60 milliseconds pulse duration), and a home-based exercise program around the knee for 30-minutes per day for three weeks. Also, each patient in group 1 received shockwaves of continuous frequency and intensity (2000 shocks, 10 Hz, 2.0 to 3.0 bar), while the second group of patients received sham-ESWT. In group 1, for a total of 3 weeks, r-ESWT was undertaken with 2000 pulse each time at a week interval totaling 6000 pulse by using a radial shock wave therapy system (vibrolith ortho tip ESWT (ELMED Turkey)).
干预措施: ESWT (Device)
Sham-ESWT group
The other group received sham-ESWT at 0.1 bar in the same area. The patients were placed supine with the affected knee at 90 degrees flexion at each treatment session. The shock wave probe was held stationary on painful points around the knee or at the patellofemoral and tibiofemoral borders of the target knee.
干预措施: ESWT (Device)
结局指标
主要结局
20-meter walk test
时间窗: up to 12 weeks
change from baseline on walking speed
isokinetic muscle performance
时间窗: up to 12 weeks
Isokinetic muscle performance was measured using a calibrated isokinetic test device named Humac®/NormTM Testing \& Rehabilitation System (Computer Sports Medicine Inc. Stoughton, MA, USA). The knee extensor/flexor muscle group isokinetic muscle strength \[peak torque (PT)\] of both groups was evaluated using a calibrated isokinetic dynamometer.
Visual Analog Scale (VAS)
时间窗: up to 12 weeks
The VAS is used to measure and monitor pain intensity. Scores range from the absence of pain (0) to intolerable pain (0 or 10)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: up to 12 weeks
Pain, joint stiffness, and physical functions were evaluated by the Western Ontario and McMaster Osteoarthritis Index (WOMAC). The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).
次要结局
未报告次要终点
研究者
Mustafa Turgut Yildizgoren
Principal Investigator, Clinical Assoc. Professor
Mustafa Kemal University