Efficacy of Radial Shockwave Therapy for Treatment of Pain in Knee Osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 4
- 主要终点
- Visual Analog Scale
研究概览
简要总结
The objective of this study is to compare the results of 2000 impulses of radius shockwaves per week with 2000 placebo shockwaves on the treatment of pain and functional incapacity of patients with severe primary knee osteoarthritis, who did not satisfactory respond to previous conventional treatments.
详细描述
- Prospective, placebo controlled randomized and double-blind study.
- Treatment Method:
Radial extracorporeal shockwaves will be applied using the Swiss Dolorclast (EMS Electro Medical Systems, Switzerland), generated by pneumatic waves.
Intervention:
- Group 1 - Intervention group Patients will receive 2,000 impulses of radial shockwave per week, with pressure of 2.5bar to 4.0bar, at the frequency of 8Hz. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
- Group 2 - Control Group:
Patients will receive 2,000 impulses of placebo radial shockwave per week, without any energy flow intensity. Frequency of 8Hz will appear in the screen. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
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)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and radiological diagnosis of primary knee diagnosis.
- •Pain intensity: Visual Analog Scale (VAS) ≥ 6;
- •One of more failures with conventional treatment (drugs, Non-Steroidal Anti-inflammatory Drugs - NSAD, physiotherapy, stretching, acupuncture, orthosis and others);
- •Age over 60 years;
- •No use of corticosteroids in the prior 48 hours;
- •No major osteoarthritis events in other joints of lower limbs (waist and ankle) and lower back;
- •No clinical evidence of related neuropathy, including radiculopathy and peripheral neuropathy;
- •Absence of systemic inflammatory disease (Rheumatoid arthritis, Reiter, ankylosing spondylitis, generalized polyarthritis, cancer);
- •Absence of infection or cancer at the application site;
- •Absence of related endocrine and metabolic diseases;
- •Absence of fibromyalgia, diagnosed after the American College of Rheumatology, 1999;
- •Absence of severe blood dyscrasias;
- •Absence of severe psychiatric disturbances that requires psychiatric assessment;
- •Availability to comply with the clinic visits and follow up evaluations along the treatment
排除标准
- •Patients who withdraw the informed consent form at any time
结局指标
主要结局
Visual Analog Scale
时间窗: Before intervention and after 3 months of the end of intervention
The Visual Analog Scale consists of a straight line of 10cm length which presents the phrase "absence of pain" (0) at one extremity, and unbearable pain (10) at the other extremity.
次要结局
- Level of tolerance of pain(Immediately before the intervention, immediately after the intervention and 3 months after the intervention.)
研究者
Marta Imamura
Medical Doctor
University of Sao Paulo