The Effectiveness of Moxibustion Treatment for Osteoarthritis of the Knee : a Double-blinded, Double-dummy, Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 主要终点
- The change of the global scale of the Western Ontario and McMaster Osteoarthritis Index (WOMAC)
研究概览
简要总结
This is a multicenter , double-blinded, double-dummy, randomized controlled clinical trial to evaluate the efficacy of moxibustion for osteoarthritis of the knee.
详细描述
Aim: To evaluate the effectiveness of moxibustion treatment for patients with osteoarthritis of the knee, with respect to relieving pain, improving the dysfunction and improving their quality of life as well.
Design: A multicentre, double-blinded, double-dummy, randomized controlled clinical study will be performed in China. Eligible participants will be randomly assigned to moxibustion group (real moxibustion plus placebo gel) and the control group (diclofenac sodium gel plus sham moxibustion) with a 1:1 allocation ratio. Participants in both groups will receive 12 sessions of real/sham moxibustion in 4 weeks at 3 acupoints (ST35, EX-LE4, ST36 ). Either diclofenac sodium gel or placebo gel will be applied 4 g per knee 4 times daily for 4 weeks. The whole study period is 13 weeks, with a 1-week run-in period, 4-week treatment phase, and 8-week follow-up phase. The primary outcome measure will be the change of the global scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at the end of the course. The secondary outcomes include the change of other subscales (pain, stiffness, and function) of WOMAC, Visual Analogue scale (VAS) and Patient Global Assessment (PGA). Safety will be assessed at every visit.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged between 40 and 75 years, with knee osteoarthritis diagnosed according to American College of Rheumatology criteria
- •Radiologic confirmation of osteoarthritis in 1 or both knees (Kellgren-Lawrence score 2 or 3)
- •Had knee pain in one or both knee(s) of longer than 3 months'duration
- •The average severity of knee pain at least 3 points on a10-point of visual analogue scale(VAS)
- •Never experienced moxibustion before this trial
- •Participants who are willing to comply with our study protocol
- •Participants who agree to sign the consent form
排除标准
- •Subjects with serious diseases including cancer, uncontrolled hypertension, diabetes mellitus requiring insulin injection, life-threatening cardiovascular or neurological events, chronic respiratory disease, a haemorrhagic disorder and serious mental diseases
- •Subjects had pain in the knee may caused by inflammatory, malignant, autoimmune disease or traumatic injury;
- •Subjects received knee replacement surgery for the affected knee
- •Subjects received knee arthroscopy within the past year, steroid or hyaluronic acid injection in the knee joints within the previous 3 months
- •Subject who currently participate in another clinical trial
- •Subjects received physiotherapy or other treatments for osteoarthritis knee pain (with the exception of non-steroidal anti-inflammatory drugs) during the previous 4 weeks;
研究组 & 干预措施
diclofenac sodium gel plus sham moxibustion
In subjects with osteoarthritis of the knee
干预措施: sham moxibustion (Other)
real moxibustion plus placebo gel
In subjects with osteoarthritis of the knee
干预措施: real moxibustion (Other)
real moxibustion plus placebo gel
In subjects with osteoarthritis of the knee
干预措施: placebo gel (Drug)
diclofenac sodium gel plus sham moxibustion
In subjects with osteoarthritis of the knee
干预措施: diclofenac sodium gel (Drug)
结局指标
主要结局
The change of the global scale of the Western Ontario and McMaster Osteoarthritis Index (WOMAC)
时间窗: 4 weeks from baseline
次要结局
- The changes from baseline to 2, 4, 8,12 weeks in the WOMAC subscales (pain, stiffness, and function)(at baseline(0 week), 2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation)
- The change of Patient global assessment score(2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation)
- The change from baseline to 2, 4, 8,12 weeks in Visual Analogue Scale for the pain intensity.(at baseline(0 week), 2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation)