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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 2
- 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.
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 (2)
Loading locations...
相似试验
Unknown
3 期
Multi-center Clinical Research of Acupuncture Treatment of Knee OsteoarthritisKnee OsteoarthritisNCT02948218Shanghai University of Traditional Chinese Medicine400
招募中
1 期
The effect of acupuncture for patients with knee osteoarthritis: a protocol for a single-blinded, double-dummy randomised controlled trialKnee osteoarthritisITMCTR2100004526The First Affiliated Hospital of Henan University of CM
Unknown
不适用
Prospective Study of Clinical Utility of Acupuncture in Back PainBack PainMusculoskeletal DiseaseNCT01231425Group G-6102
已完成
不适用
Effect of Distal Needling on Knee Pain Using Acupuncture TechniquesPatellar TendonitisComplete Tear, Knee, Anterior Cruciate LigamentNCT01612663Hadassah Medical Organization70
撤回
不适用
Acupuncture for Pain Management After Hip or Knee ArthroplastyPainPostoperative ComplicationsNCT00455182HealthEast Care System