NCT00404443已完成2 期
Efficacy of Traditional Chinese Acupuncture in the Treatment of Rheumatoid Arthritis: a Double-Blind Controlled Pilot Study
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The changes in the pain score.
研究概览
简要总结
To study the efficacy of acupuncture used as an adjunct measure for patients with refractory RA
详细描述
The study employs a randomized, prospective, double-blind, placebo-controlled trial to evaluate the effect of electroacupuncture, traditional Chinese acupuncture and sham acupuncture in patients with refractory RA. All patients received 20 sessions over a period of 10 weeks. Six acupuncture points were chosen. Primary outcome is the changes in the pain score. Secondary outcomes included the changes in the ACR core disease measures, DAS 28 score and the number of patients who achieved ACR 20 at week 10.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfilled The American College of Rheumatology (ACR)[10] criteria of RA
- •Active disease affecting the hands and wrists defined as having at least 4 tender joints and 2 swollen joints
- •Early morning stiffness of greater than 45 minutes
- •ESR > 28 mmHg or CRP > 10
- •Patients taking disease modifying anti-rheumatic drugs (DMARDs) were eligible if they were on a stable dose for at least 3 months before screening.
- •Patients on stable doses of one non-steroidal anti-inflammatory drug (NSAID) or up to 10 mg daily prednisone were also included.
排除标准
- •Under the age of 18 years
- •Pregnancy
- •Previously had acupuncture
- •Localized skin infections
- •Anticoagulated
- •Bleeding diathesis
- •Intra-articular corticosteroid within 4 weeks preceding the study
- •Any severe chronic or uncontrolled co-morbid disease
- •Fear of needles
研究组 & 干预措施
1
Sham Comparator
arm 1: placebo needle
干预措施: Acupuncture (Device)
结局指标
主要结局
The changes in the pain score.
时间窗: wk52
次要结局
- The ACR core disease measures(wk52)
- DAS 28 score(wk52)
- The number of patients who achieved ACR 20 at week 10.(wk52)
研究者
研究点 (1)
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