The East-Midlands Knee Pain Multiple Randomised Controlled Trial Cohort Study: Cohort Establishment and Feasibility Cohort-randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,806
- 试验地点
- 2
- 主要终点
- The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
研究概览
简要总结
- To develop a training package for nurse-led management of knee osteoarthritis (OA), incorporating information about OA and core non-pharmacologic and pharmacologic principles of management of OA as recommended in the National Institute for Clinical Excellence and Health (NICE) guidelines for management of OA
- To evaluate fidelity of delivery of individual components of this complex package of care for knee pain
- To assess the acceptability of the intervention by exploring participant satisfaction with nurse-led complex package of care of knee pain.
- To explore and resolve possible challenges to delivery of individual components within a complex package
- To examine the feasibility of a definitive cohort randomised controlled trial of nurse-led care versus usual care of knee pain in terms of recruitment rate, drop-out rate, reasons for dropping out and completeness of outcome data
- To explore whether such a trial should provide analgesia before non-pharmacologic interventions or vice versa
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Knee pain on most days of the previous month
- •At least moderate pain on two of the five WOMAC knee pain domains in the most painful knee
- •Knee pain present for longer than 3 months
排除标准
- •House-bound or care home resident
- •On home oxygen
- •Serious mental illness
- •Inability to communicate in English
- •Unable to give consent
- •Terminal cancer
- •Known diagnosis of autoimmune rheumatic diseases or psoriasis
- •Knee or hip replacement, or on waiting list for knee or hip replacement
- •Asthma or COPD requiring regular daily oral corticosteroids
- •Unstable angina or heart failure
- •Known peripheral vascular disease
结局指标
主要结局
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: 26 weeks
questionnairehe Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties
次要结局
未报告次要终点