Acupuncture for Knee Osteoarthritis With Sensitized Acupoints: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 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 undertake a rigorous multicentre randomised controlled trial, comparing acupuncture on sensitized acupoints with low/non-sensitive points or no acupuncture (waiting-list), to test if acupuncture on sensitized acupoints may result in improved treatment outcomes in patients with Knee osteoarthritis (KOA).The current pilot study aimed to assess the feasibility of performing the definitive randomised controlled trial.
详细描述
Patients in the intervention group received acupuncture treatment on the 5 most sensitized points/ acupoints.Patients in the control group received acupuncture treatment on the 5 least /non-sensitized points. All other treatment settings were the same as in the intervention group.
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
- •Eligible patients are those aged 40 years or older who are diagnosed with KOA and have signed the informed consent.
- •The diagnosis of KOA will follow the diagnostic criteria according to the Chinese Guidelines for the Medical Management of Osteoarthritis:
- •refractory knee pain for most days in the last month;
- •joint space narrowing, sclerosis or cystic change in subchondral bone (as indicated by X-ray);
- •laboratory examinations of arthritis: clear and viscous synovial fluid (≥2 times) and white blood cell count < 2000/mm3;
- •age 40 years or older;
- •morning stiffness continues less than 30 minutes;
- •bone sound exists when joints was taking flexion and/or extension. A person is confirmed to be diagnosed with KOA if meeting the either of the three criteria set: (1 and 2), or (1,3 and 5), or (1,4,5 and 6).
排除标准
- •Patients will be excluded if they:
- •Can not adhere to the study protocol in the future 6 months;
- •Are diagnosed with conditions leading to skeletal disorders, such as tuberculosis, tumors or rheumatism of knee/bone joint, rheumatoid arthritis;
- •Have sprain or other trauma;
- •Are unable to walk properly due to foot deformity or pain;
- •Are present with mental disorders;
- •Have comorbidities including severe cardiovascular disease, liver or kidney impairment, immunodeficiency, diabetes mellitus or blood disorder;
- •Females who are pregnant or lactating;
- •Were using physiotherapy treatments for osteoarthritis knee pain;
- •Had used intra-articular injection of glucocorticoid or viscosupplementation in the past 6 months;
- •Received knee-replacement surgery;
- •Were participating or had participated in the other clinical trials.
研究组 & 干预措施
experimental group: Acupuncture
acupuncture on 5 most sensitized points/ acupoints
干预措施: acupuncture (Other)
Control group: Acupuncture
acupuncture on 5 least low/non-sensitized points
干预措施: acupuncture (Other)
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 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)