Central Pain Mechanisms in Patients With Hand-Osteoarthritis, Psoriatic Arthritis and Healthy Controls
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Between group difference in Pressure pain threshold (PPT)
研究概览
简要总结
In this trial different parts of the pain signalling system involved in two rheumatic diseases - painful hand osteoarthritis and psoriatic arthritis, is examined. These measurements will be compared to those of healthy volunteers
The hypothesis is that patients with hand osteoarthritis and psoriatic arthritis react differently to painful and non-painful stimuli compared with the healthy volunteers.
The aim is to recruit 66 patients with painful hand-osteoarthritis, 66 patients with painful psoriatic arthritis and 66 healthy subjects not currently suffering from any pain conditions.
After completing an informed consent form subjects will participate in a single clinical visit. The pain signalling system is examined using pressure algometry and cuff algometry. A pressure algometer is a pistol shaped device that elicits pressure through a rod and a cuff algometer is akin to a blood pressure cuff. Different thresholds will be measured, such as when the sensation of pressure becomes painful and when the painful pressure becomes unbearable.
Participants will also get hand strength tested, have their joints examined and answer questionnaires regarding daily function and quality of life.
Furthermore participants will get blood drawn which is analysed for the presence of markers of inflammation and joint degeneration.
详细描述
Purpose and rationale for this study:
Treating painful hand osteoarthritis (Hand-OA) and psoriatic arthritis (PsA) is a clinical challenge because the exact pain mechanisms remain unknown. Both conditions seem to involve both central and peripheral pain mechanisms and inflammation to some degree. However, it remains unknown whether the pain mechanisms are homogenous among patients with said conditions or if different pain phenotypes exist that may respond differently to treatments.
The initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consortium has recognized this. IMMPACT recommends that clinical trials with chronic pain patients assess different domains of the pain experience (psychosocial, pain qualities, sleep, and pain pathways) to examine if pain phenotypes exist and whether different treatment modalities are more effective for certain phenotypes.
Methods: A cross-sectional study examining the difference in pain phenotype and pain mechanisms between patients with Hand-OA, PsA and healthy pain free controls using questionnaire assessments and quantitative sensory testing aiming at investigating pain pathways in the central nervous system. Participants will also have blood drawn to evaluate serological biomarkers for inflammation and joint degeneration.
Aim: To examine the pain phenotypes and assess differences in pressure pain threshold between patients with Hand-OA, PsA and healthy pain free controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Other known inflammatory rheumatic disease (i.e. rheumatoid arthritis, gout) *
- •Erosive Hand-OA (One or more erosive joints on plain x-ray)
- •Isolated Hand-OA of the first metacarpal joint or this joint as the most painful*
- •Other known pain condition (i.e. fibromyalgia, Carpel tunnel syndrome, polyneuropathy)
- •Other known disease where exacerbations need to be treated with systemic corticosteroids (i.e. certain types of inflammatory bowl disease) or patients who have received systemic corticosteroid treatment during the last 3 months.
- •Planning pregnancy, pregnant or breastfeeding. (Fertile women will be tested for pregnancy)
- •Planned major surgery or recent major surgery (last 8weeks)
- •Verified malignant disease
- •History of epilepsy or severe cramps
- •History of serious cardiovascular pathology
- •Lacking ability to corporate with the research staff.
结局指标
主要结局
Between group difference in Pressure pain threshold (PPT)
时间窗: Day One
Difference PPT between groups measured in kPa
次要结局
未报告次要终点
研究者
Jonathan Vela
Medical Doctor
Aalborg University Hospital