Central Pain Mechanisms in Osteoarthritis: A Longitudinal Cohort
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
The primary objective of this study is to evaluate the relative efficacy of a centrally-acting analgesic (duloxetine) versus a peripherally acting analgesic (topical diclofenac) for pain and associated symptom management in knee osteoarthritis. Secondary objectives include the determination of which self-report and experimental pain measures best differentiate those who respond better to duloxetine than diclofenac.
详细描述
This is a randomized, blinded, crossover, controlled study design comparing duloxetine and topical diclofenac for osteoarthritis pain.
The study cohort will be individuals who have a confirmed diagnosis of knee osteoarthritis. Subjects will be randomized only after all entry criteria have been met. These individuals will be evaluated at baseline, and then followed longitudinally following enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with knee osteoarthritis as defined by American College of Rheumatology (ACR) criteria
- •Males and females age greater than 50 years at time of screening
排除标准
- •History of chronic kidney disease or moderate to severe hepatic impairment
- •History of anemia
- •Allergy or intolerance of drug intervention
- •Inability to participate in outcome measures
结局指标
主要结局
Pain
时间窗: One month
次要结局
未报告次要终点
研究者
Kristine Phillips
Associate Professor
University of Michigan