New Options for Treating Knee Osteoarthritis Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Change in Osteoarthritis symptoms
研究概览
简要总结
This study will be a single-site, four-arm, randomized, placebo-controlled clinical trial. Knee osteoarthritis patients (N=164) will be randomized to Reiki, Sham Reiki (placebo control), mindfulness meditation (active control), or a waitlist control condition. The three active interventions will be applied for 20 minutes, once a week, for four consecutive weeks in a university laboratory setting.
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
- Triple (Participant, 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
- •Osteoarthritis in at least one knee
- •Report a WOMAC pain score average >/= 2
- •Not using any kind of energy therapy different from the proposed study
- •Ability to read, understand and speak English
排除标准
- •Knee arthroplasty in the previous year
- •Have cognitive impairment as determined by clinical interview
结局指标
主要结局
Change in Osteoarthritis symptoms
时间窗: One week before treatment to one week after treatment, which comprises a 6 week span
The Western Ontario and McMaster Universities Arthritis Index will be used to measure change in osteoarthritis symptoms. Scores range from 0 to 96, with higher scores reflect worse pain, stiffness and physical function
次要结局
- Change in Pain Catastrophizing(One week before treatment to one week after treatment, which comprises a 6 week span)
- Change in Quality of Life(One week before treatment to one week after treatment, which comprises a 6 week span)
- Change in Acute Pain Intensity(Immediately before to after the first and last treatment session, which comprises a 20 minute span)
- Change in Anxiety(One week before treatment to one week after treatment, which comprises a 6 week span)
- Change in Depression(One week before treatment to one week after treatment, which comprises a 6 week span)
- Change in Sleep(One week before treatment to one week after treatment, which comprises a 6 week span)
研究者
Adam Hanley
Principal Investigator, Assistant Professor
University of Utah