Multidimensional Evaluation of Pain in Rheumatoid Arthritis (Douleur PR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 7
- 主要终点
- Evaluation of the pain
研究概览
简要总结
Rheumatoid Arthritis (RA) is an inflammatory chronic rheumatism where the pain remains the priority domain of improvement for the patients instead a good control of the inflammatory disease by treatments, even biotherapeutics .
Some studies show that less than 50 % of the patients is satisfied by the care of the pain, whereas the criteria of evaluation of the RA improve under treatment. The chronic pain, is a complex and multifactorial subjective phenomenon requiring a multidimensional evaluation, while the current criteria of follow-up of the RA (DAS28, ACR criteria) investigate the pain in a single dimension that is the pain intensity.
So, the investigators do not arrange explanation for this observed dichotomy between the improvement of the clinical and biological inflammatory criteria of the RA and on the other hand the persistence of pain.
On the other hand, the interleukin (IL)-6, IL-17 and IL-33 are cytokines occurring in the physiopathology of RA and probably in the pain processing according to recent data of the literature.
The aim of this study is:
- to assess the multidimensional origin of the pain in RA patients by means of questionnaires
- to look for a possible correlation between the serum level of cytokines and pain.
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
- •Adults with RA treated with DMARDs and/or biotherapy,
- •Capable of providing written consent
排除标准
- •Patients affected by a painful disease other one than RA,
- •Fibromyalgia,
- •A malignancy disease,
- •An hemopathy,
- •Psychiatric disorders or dementia and
- •Acute infectious diseases and
- •Receive or had received anti-IL6 therapy
结局指标
主要结局
Evaluation of the pain
时间窗: At day 1
Multidimensional evaluation of the pain using standard questionnaires: HAS, Beck and Speilberger , Erosion Narrow Score and Fibromyalgia diagnostic criteria
次要结局
- Correlation(At day 1)
- Patients pain care(At day 1)
