The Efficacy of Radial Extracorporeal Shockwave Therapy (RESWT) for Functional Improvement of Patients With Knee Osteoarthritis - A Double-blind Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Functional Change
研究概览
简要总结
This is a double-blind placebo controlled trial whose objective is to understand how much the radial extracorporeal shockwave therapy can improve function of patients with knee osteoarthritis.
For this trial, patients with knee osteoarthritis, after signing the informed consent form and having their demographic and baseline information collected, will be randomly allocated into one of both treatment arms: radial extracorporeal shockwave therapy (rESWT) or sham radial extracorporeal shockwave therapy. Then, they will undertake three sessions of rESWT, for three weeks, i.e. one session per week.
Patients will be assessed prior to the therapy, one week after the end of the therapy and three months after the end of the therapy, and the primary outcome of this study is the functional change measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) validated in Portuguese, three months after the end of the therapy.
Secondary outcomes, will be the change of pain, the change of pressure pain tolerance threshold, change in diffuse noxious inhibitory control (DNIC), and thermographic changes.
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
- Quadruple (Participant, Care Provider, 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
- •Clinical diagnosis of knee osteoarthritis;
- •Onset knee pain with moderate or severe intensity: Visual Analogue Scale (VAS) > 4;
- •Onset knee pain over 3 months prior to the inclusion;
排除标准
- •Presence of psychiatric disease;
- •Presence of fibromyalgia;
- •Presence of systemic inflammatory rheumatic diseases;
- •History of neoplasia;
- •Presence of clinical diseases in other joints;
- •Ongoing use of anticoagulant drugs.
结局指标
主要结局
Functional Change
时间窗: At baseline and three months after the end of the treatment.
Functional change from baseline, measured by KOOS.
次要结局
- Pain pressure threshold tolerance changes(At baseline, one week and three months after the end of the treatment)
- Thermography evaluation(At baseline, one week and three months after the end of the treatment)
- Diffuse noxious inhibitory control alterations(At baseline, one week and three months after the end of the treatment)
- Short Term Functional Changes(At baseline and one week after the end of the treatment.)
- Knee pain reduction(At baseline, one week and three months after the end of the treatment)
研究者
Marta Imamura
Principal Investigator
University of Sao Paulo