A Multi-center Randomized Controlled Trial of Acupuncture Treatment for Knee Osteoarthritis With Sensitive Acupoints and Tender Points
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 666
- 试验地点
- 4
- 主要终点
- The change of Western Ontario and McMaster Universities Osteoarthritis index total score from baseline to 16 weeks
研究概览
简要总结
The investigators plan to investigate the effectiveness of acupuncture at highly sensitive points, compared with lowly/non-sensitive points or no acupuncture (waiting-list), in improving pain, joint function and quality of life, among patients with KOA. The safety of acupuncture will also be assessed during the study period.
详细描述
Participants in the high sensitization group receive acupuncture treatment at the five highly sensitive points; Participants in the low/non-sensitization group receive acupuncture treatment at the five low/non-sensitive points and all other treatment settings will be the same as in the high sensitization group. Patients in the waiting-list group will receive standard acupuncture treatment after the study is completed.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 40 years or older and diagnosed with mild or moderate knee osteoarthritis(KOA) are eligible to participate in the study
- •The following criteria are used for diagnosis of KOA:
- •refractory knee pain for most days in the last month;
- •joint space narrowing, sclerosis or cystic change in subchondral bone (as demonstrated in X-ray);
- •laboratory examinations of arthritis: clear and viscous synovial fluid (≥2 times) and white blood cell count < 2000/mm3;
- •morning stiffness continues less than 30 minutes;
- •bone sound exists when joints was taking flexion and/or extension. If a patient meets criteria 1 and 2, or criteria 1, 3, 4, and 5, a diagnosis of KOA is confirmed.
排除标准
- •Patients will be excluded if they meet any of the following:
- •diagnosed with conditions leading to skeletal disorders, such as tuberculosis, tumors or rheumatism of the knee joint and rheumatoid arthritis;
- •present sprain or trauma in the lower limb;
- •unable to walk properly due to foot deformity or pain;
- •present with mental disorders;
- •present with comorbidities including severe cardiovascular disease, liver or kidney impairment, immunodeficiency, diabetes mellitus, blood disorder or skin disease;
- •females who are pregnant or lactating;
- •using physiotherapy treatments for osteoarthritis knee pain;
- •have used intra-articular injection of glucocorticoid or viscosupplementation in the past six months;
- •received knee-replacement surgery;
- •diagnosed with severe (stage 4, according to Kellgren and Lawrence radiographic classification) or late clinical stage of KOA;
- •have a swollen knee or positive result of floating patella test; or'
- •are participating or have participated in the other clinical trials.
结局指标
主要结局
The change of Western Ontario and McMaster Universities Osteoarthritis index total score from baseline to 16 weeks
时间窗: Assessments will be conducted at baseline and 16 weeks after randomization
It consists of 24 items assessing the knee osteoarthritis patients pain, stiffness, and physical function. Each of the 24 items will be graded on a visual analog scale ranging from 0 to 10, with higher scores reflecting more pain, stiffness and poorer physical function.
次要结局
- The changes of knee ranges of motion (ROMs) from baseline to 16 weeks(Assessments will be conducted at baseline and 16 weeks after randomization)
- The changes of pressure-pain threshold of the five selected acupuncture points from baseline to 16 weeks(Assessments will be conducted at baseline and 16 weeks after randomization)
- The change of Short Form (SF)-12 health survey score from baseline to 16 weeks(Assessments will be conducted at baseline and 16 weeks after randomization)