Central Aspects of Pain in Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Psychometric properties of CAP-RA
研究概览
简要总结
This study seeks to measure the psychometric properties of a newly developed Central Aspects of Pain in Rheumatoid Arthritis (CAP-RA) questionnaire, and investigate the ability of this questionnaire to measure central mechanisms of pain and also to predict worse pain and fatigue outcomes in people with Rheumatoid Arthritis (RA).
详细描述
Persistent pain and fatigue are prevalent and disabling symptoms in people with Rheumatoid Arthritis, even in the absence of active inflammation. The investigators believe that these symptoms may be a result of abnormal pain processing by the Central Nervous System (CNS), in a process called central sensitization.
The investigators have developed a short, self-report questionnaire to measure central pain mechanisms in people with RA. It is called Central Aspects of Pain in Rheumatoid Arthritis (CAP-RA), and was adapted from a pre-existing questionnaire called CAP-Knee (which measures central sensitization in people with chronic knee pain).
This study aims to measure the psychometric properties of CAP-RA, and the ability of the questionnaire to predict worse pain in the RA population. Secondary objectives of the study include predicting worse fatigue in people with RA, deriving CAP-RA scoring recommendations, investigating other factors associated with persistent RA pain, the association between central sensitization and pain, and investigating the course of pain and fatigue in RA.
Participants will be recruited from a Rheumatology clinic. At baseline and 12 weeks these participants will undergo quantitative sensory testing (QST, pain tests), ultrasound for synovitis, clinical assessments, laboratory tests for systemic inflammation and, complete a questionnaire booklet, including the CAP-RA questionnaire.
Some participants will complete the CAP-RA questionnaire 1 week after the baseline visit to assess the test-retest reliability of the questionnaire.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult (age≥18y) of any sex and ethnicity.
- •Satisfy EULAR criteria for RA.
- •Active RA, as defined as DAS28 ≥3.2 at baseline visit
排除标准
- •Unable to give informed consent.
- •Insufficient understanding of spoken or written English to comply with the requirements of the study protocol
- •Unable or unlikely to complete the proposed 12-week study follow up (eg. moving house, terminal diagnosis, current or planned pregnancy).
- •Active comorbidity (e.g. uncontrolled diabetes mellitus, cancer, infection) requiring changes in medical treatment at baseline
- •Major active psychiatric condition (e.g. major depression)
- •Inability to meet the requirements of clinical assessments
结局指标
主要结局
Psychometric properties of CAP-RA
时间窗: 1 week test-retest
A detailed assessment of the psychometric properties of CAP-RA. Higher scores indicate stronger central mechanisms of pain
Bodily pain
时间窗: 12 weeks
Numerical Rating Scale (0-10) of bodily pain - increasing severity
次要结局
- Swollen joints(12 weeks)
- Quantitative Sensory Testing(12 weeks)
- Fatigue(12 weeks)
- Physical activity(12 weeks)
- Functional status(12 weeks)
- Change and trajectory of bodily pain(12 weeks)
- Change and trajectory of fatigue(12 weeks)
- Neuropathic pain mechanisms(12 weeks)
- Mental health(12 weeks)
- Central sensitization(12 weeks)
- Joint inflammation(12 weeks)
- Inflammation-Erythrocyte sedimentation rate(12 weeks)
- Inflammation-CRP(12 weeks)