NCT05038553进行中（未招募）不适用
CNS Pain Mechanisms in Early Rheumatoid Arthritis: Implications for the Acute to Chronic Pain Transition
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 125
- 试验地点
- 9
- 主要终点
- Fibromyalgia Survey Criteria
研究概览
简要总结
The objective is to identify modifiable clinical factors and neurobiological pathways that lead to the development of chronic pain in patients with early rheumatoid arthritis. Participants will undergo quantitative sensory testing, a type of testing that involves assessing response to well-defined, quantifiable painful stimuli, at 0, 3, and 12 months. A subset of participants will also undergo magnetic resonance imaging at 0 and 12 months to assess neuroimaging markers that have previously been shown to be involved in chronic 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
- •Age ≥18 years
- •Meet either the 1987 or 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria for RA
- •Persistent joint symptoms ≤ 2 years
- •Active inflammatory disease
- •If taking opioids on an as needed (prn) basis, must be able to hold opioid for 12 hours before study procedures
- •If taking NSAIDs, must be able to hold NSAIDS for 24 hours before study procedures
- •If taking a central-acting pain medication, must be on a stable dose and able to stay on a stable dose throughout study
排除标准
- •Routine, scheduled opioid use
- •Routine, scheduled prednisone dose >10 mg or its equivalent
- •Peripheral neuropathy
- •Peripheral vascular disease
- •Raynaud's phenomenon requiring treatment, manifested by claudication or ischemic rest pain
- •Uncontrolled blood pressure
- •Additional Inclusion Criteria for neuroimaging:
- •Age ≤ 80 years old
- •Right-handed or ambidextrous
- •Ability to lie on their back for the duration of the MRI scans
- •Additional Exclusion Criteria for neuroimaging:
- •Severe claustrophobia precluding MRI
- •Unable to fit comfortably in the MRI scanner (usually only occurs if body mass index >40 kg/m2)
- •Contraindications to MRI
结局指标
主要结局
Fibromyalgia Survey Criteria
时间窗: 12 months
Minimum value 0, maximum value 31; higher scores indicate worse outcomes
次要结局
未报告次要终点
研究者
Yvonne Lee
Associate Professor of Medicine and Preventive Medicine
Northwestern University
研究点 (9)
Loading locations...
相似试验
已完成
不适用
Central Aspects of Pain in Rheumatoid ArthritisRheumatoid ArthritisNCT04515589University of Nottingham95
已完成
不适用
Probing the Rheumatoid Arthritis Brain to Elucidate Central Pain PathwaysRheumatoid ArthritisNCT05693532NHS Greater Glasgow and Clyde13
已完成
不适用
Foot Orthotic for Early Stage Rheumatoid ArthritisRheumatoid Arthritis of Foot (Disorder)Rheumatoid ArthritisNCT03561688Vendsyssel Hospital27
进行中（未招募）
不适用
Pain mechanisms and fatigue in rheumatoid arthritis (RA) and healthy volunteers. Can antirheumatic and biological therapy affect pain processing and fatigue in RA? - RA PAIN PROCESSINGEUCTR2008-005212-40-SEKarolinska Institute
已完成
不适用
Evaluation of the Effect of Neuropathic Pain on Quality of Life in Rheumatoid Arthritis PatientsNeuropathic PainRheumatoid ArthritisNCT04820426Ahi Evran University Education and Research Hospital85