Evaluation of Questionnaire Measures for Patients With Osteoarthritis of the Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 448
- 试验地点
- 3
- 主要终点
- Questionnaire set assessing physical symptoms, cognitive and emotional factors, and quality of life in knee OA.
研究概览
简要总结
The aim is to improve understanding of the assessment of pain experience in patients with osteoarthritis (OA) of the knee. The current study will be divided into two parts. In Study 1, the investigators will analyse existing questionnaires relevant to the mechanisms and therapeutic targets of knee OA to establish discrete dimensions that discriminate between the different mechanisms of pain. On the basis of this analysis, the investigators will refine the questionnaires to maximise their sensitivity to knee OA. In Study 2, the investigators will seek to confirm the factor structure identified in the questionnaires in Study 1 and explore potential mediator and moderator variables between pain and quality of life using the refined measures. The investigators will also evaluate Quantitative Sensory Testing as a predictor of OA knee pain.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Participants in Study 1 will have OA of the knee defined and scored radiologically and will report knee pain. Participants in Study 2 will also have OA of the knee, but a clinical diagnosis will suffice.
排除标准
- •Inability to speak or understand English
- •Under the age of 18 years old
- •knee joint surgery within three months prior to participation
- •Diagnosed Rheumatoid Arthritis, Psoriatic Arthritis, Gout or any other inflammatory arthritis disorder
- •The participants in Study 2 will also be excluded if they participated in Study 1
结局指标
主要结局
Questionnaire set assessing physical symptoms, cognitive and emotional factors, and quality of life in knee OA.
时间窗: Patients will be assessed after diagnosis of OA of the knee. There is no specific time point after diagnosis, because we are interested in a broad spectrum of patients with OA of the knee. All patients will be assessed at enrollment into the study.
Patients will be given a questionnaire set assessing pain (nociceptive and neuropathic), anxiety, depression, fatigue, illness belief, pain self-efficacy, coping, helplessness and quality of life, associated with OA of the knee. The psychometric properties of the questionnaire set will be reported, including results from Rasch Analysis, Cronbach's Alpha and results from Factor Analysis.
次要结局
- Quantitative Sensory Testing assessing pain and sensory thresholds for a noxious stimulus (Pain Pressure Thresholds)(Patients will be assessed after diagnosis of OA of the knee. There is no specific time point after diagnosis, because we are interested in a broad spectrum of patients with OA of the knee.)