NCT00694447已完成不适用
Exploring Outcomes and Mechanisms of Acupuncture in Treating Pain and Sleep Disturbance in Knee Osteoarthritis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Sleep disturbances as recorded by wrist actigraph, including sleep duration and sleep efficiency. Pain as measured by 0-10 VAS and WOMAC pain scores.
研究概览
简要总结
The hypotheses of this study are: In the older population with knee OA,
- When acupoints are chosen for both sleep and pain, there are additive effects on sleep improvement and pain relief (i.e. no interaction).
- Main effects of acupuncture on sleep improvement and pain relief are anticipated when acupoints are separately targeted for sleep and for pain, respectively.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with knee osteoarthritis, diagnosed by the ACR clinical diagnosis criteria for idiopathic OA, with at least Kellgren and Lawrence grading II and above. AND,
- •Present with knee pain at least half of the time. AND,
- •Complain of sleep disturbances associated with knee OA, with Pittsburgh Sleep Quality Index > 5 [36].
排除标准
- •Patients with diagnosis of obstructive sleep apnea (OSA). OR,
- •Patients with dense hemiplegia secondary to cerebrovascular accident. OR,
- •NYHA Class III - patients with heart failure condition limited by minimal activity. OR,
- •Severe COPD with shortness of breath at minimal exertion. OR,
- •Peripheral vascular disease with severe claudication. OR,
- •Dementia with Mini Mental Status Exam score of 20 or less. OR,
- •Patients who received knee intra-articular corticosteroid injection within 4 weeks prior to the study or who received acupuncture treatment within 6 months. OR,
- •Unwilling to come off narcotic pain medication. OR,
- •History of bleeding diathesis or currently on anticoagulation. OR,
- •Patients currently engaged in medical legal cases related to OA or disability.
研究组 & 干预措施
Real acupuncture
Experimental
Real acupuncture
干预措施: Acupuncture (Procedure)
Sham acupuncture
Sham Comparator
Sham acupuncture
干预措施: Acupuncture (Procedure)
结局指标
主要结局
Sleep disturbances as recorded by wrist actigraph, including sleep duration and sleep efficiency. Pain as measured by 0-10 VAS and WOMAC pain scores.
时间窗: at least 3 months
次要结局
- WOMAC disability scores, IDEEA gait patterns and activity levels, medication type and amount consumed, side effects, and medical care utilization.(at least 3 months)
研究者
Wei Huang MD, PhD
Principal Investigator
Emory University
研究点 (1)
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