NCT00493753已完成不适用
Feasibility and Safety of Acupuncture for Systemic Lupus Erythematosus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Safety (side effect and adverse event rates), protocol adherence (expected 80% of sessions completed on time)
研究概览
简要总结
The aim of this pilot study was to evaluate whether acupuncture is safe and acceptable to people with systemic lupus erythematosus (SLE). Twenty-four SLE patients were assigned randomly to receive either 10 sessions of acupuncture, 10 sessions of a minimal-needling control intervention, or their usual medical care alone. It was hypothesized that acupuncture would be safe for people with SLE, and that participants would be able to complete their assigned treatment within 5 to 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 盲法
- Single
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
- •diagnosed with SLE, 18 years old or older, pain duration at least 3 times per week for at least 3 months, medications and doses stable for the past month, able to speak, read, and understand English, and provide informed consent.
排除标准
- •known pregnancy, active uncontrolled organ involvement, steroid dose greater than 10 mg per day, platelets < 100,000, previous course of acupuncture treatment.
结局指标
主要结局
Safety (side effect and adverse event rates), protocol adherence (expected 80% of sessions completed on time)
时间窗: 6 weeks
次要结局
- pre-post treatment effect size estimates for self-reported pain and fatigue(6 weeks)
研究者
研究点 (4)
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