Phenotyping of Chronic Pain in Diffused Systemic Scleroderma: Characteristics and Perturbations of Mechanisms of Pain, Impact on the Quality of Life and Correlations of Fatigue, Sleeping Disorders and Mood or Anxiety Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Assessment of pain by BPI
研究概览
简要总结
The primary objective of the study is to describe the different phenotyping of pain in systemic scleroderma patients and perturbations of mechanisms of the pain.
As secondary objectives, the study aims to describe the importances of overall symptoms in alteration of quality of life and conserve the questions which will be associated in a unique questionnaire in order to evaluate the pain, the fatigue and the sleeping disorders in diffused systemic scleroderma patients.
详细描述
This is a prospective, non-randomized, controlled study.
Beside the routine care, the patients will have only one visit in the study during which the informed consent will be signed, also the following will be performed: pain evaluation, blood sampling, questionnaires and Sudoscan, test QST.
100 patients will be enrolled in total with 50 in each group (scleroderma with pain vs. scleroderma without pain, 1:1 ratio), the duration of inclusion is estimated for 23 months.
2 centers will be involved in the enrollment of patients: rheumatology department and interne medicine department of Cochin hospital-APHP. One center will perform the evaluations of pain for all patients: center of pain of Cochin hospital - APHP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Patients ≥ 18 years;
- •Patients with diffused SSc according to ACR / EULAR Classification 2013 since at least 3 months;
- •For group pain: pain intensity ≥4 of 11 points of scale (NRS);
- •For group painless: pain intensity on the month before inclusion.
排除标准
- •Patients unable to understand french language;
- •Patients no-affiliated to the french social security scheme;
- •Patients under the french AME scheme;
- •Patients under guardianship;
- •Pregnant and breastfeeding patients;
- •Patients with thermoalgesic neuropathy;
- •Articular pain from degenerative diseases (known osteoarthritis);
- •Patients under antidepressant;
- •Temporary discontinuation of analgesics which are not well tolerated.
结局指标
主要结局
Assessment of pain by BPI
时间窗: at baseline
Pain will be evaluated by the Brief Pain Inventory (BPI)
Assessment of pain by NRS
时间窗: at baseline
Pain will be evaluated by the numerical pain rating scale (NRS).
Assessment of pain by Pain Detect Questionnaires
时间窗: at baseline
Pain will be evaluated by the painDETECT questionnaire.
Assessment of pain by FiRST
时间窗: at baseline
Pain will be evaluated by the Fibromyalgia Rapid Screening Tool (FiRST).
Assessment of pain
时间窗: at baseline
McGill Pain Questionnaire (MPQ) will be used. McGill Pain Questionnaire is a self-report questionnaire for multidimensional pain assessment in chronic pain.
Assessment of pain by DN4
时间窗: at baseline
Pain will be evaluated by the Douleur Neuropathique (DN4) questionnaire as tool.
次要结局
- Assessment of quality of life by questionnaire EQ5D(at baseline)
- Assessment of quality of life by questionnaire HAQ.(at baseline)
- SSc-SAQ questionnaire development(through study completion, an average of 2 years)