Advancing the Understanding of Pain Mechanisms in Inflammatory Arthritis Towards Precision Pain Management
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- PROMIS Pain Interference - Short Form 8a
研究概览
简要总结
Our primary objective is to better understand the etiology and consequences of chronic paint by using an explorative approach to identify phenotypes and endotypes of patients with inflammatory joint diseases, with a special focus on central sensitization and cognitive functioning as a key element in chronic pain. We will also examine the risk factors and clinical impact of these factors on pain, disease activity and treatment effects in a longitudinal study of patients with inflammatory joint disesases.
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
- •All patients who initiate or switch biological or targeted synthetic DMARDs
排除标准
- 未提供
研究组 & 干预措施
Patients who initiate or switch biological or targeted synthetic DMARD
All patients initiate or switch biological or targeted synthetic DMARD
干预措施: Biological or targeted synthetic DMARD (Drug)
结局指标
主要结局
PROMIS Pain Interference - Short Form 8a
时间窗: Baseline, 3 months
PROMIS Pain Interference - Short Form 8a assesses to which extend pain affect various aspects in daily life. This includes 8 items covering social, emotional, physical, and recreational activities \[74\], such as "How much did pain interfere with your day-to-day activities?" and "How much did pain interfere with your enjoyment of life?". The items have a 7-day time frame. Participants are asked to rate their responses on a three different 5-point Likert response scales. Scores are converted to a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD). Higher scores represent more pain interference.
次要结局
- Social network(Baseline)
- Gender role perception(Baseline)
- Arthritis Self-Efficacy Scale (ASES)(Baseline)
- Pain Catastrophizing Scale (PSC)(Baseline)
- Douleur Neuropathique 4 (DN4)(Baseline and 3 months)
- Painful joint count (Homunculus)(Baseline and 3 months)
- Patient Health Questionnaire (PHQ)(Baseline)
- General Anxiety Disorder Questionnaire (GAD-7)(Baseline)
- Psoriatic Arthritis Impact of Disease (PsAID)(Baseline)
- MetaCognitions Questionnaire 30* (MCQ-30)(Baseline)
- Pain Metacognition Questionnaire (PMQ)(Baseline)
- Everyday Memory Questionnaire - revised (EMQ)(Baseline)
- Stanford Expectation of Treatment Scale (SETS)(Baseline)
- Gender Role Expectations of Pain (GREP)(Baseline)
- American College of Rheumatology (ACR) criteria for fibromyalgia(Baseline)
- Cambridge Neuropsychological Test Automated Battery (CANTAB)(Baseline)
- Height and weight(Baseline)
- Hand preference(Baseline)
- Quantitative sensory testing (QST)(Baseline, 3 months)
- Biobank(Baseline)
- Psoriatic Arthritis Impact of Disease (PsAID)(Baseline and 3 months)
- Pain Metacognition Questionnaire (PMQ)(Baseline and 3 months)
- Everyday Memory Questionnaire - revised (EMQ)(Baseline and 3 months)
- Ultrasound of joints and tendons(Baseline and 3 months)
- MRI(Baseline)
- Treatments(Baseline)
研究者
Ida Kristin Haugen
MD PhD
Diakonhjemmet Hospital