Effect of Smoking on Pain and Atherosclerosis in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Pain sensitivity (Pressure Pain Detection Threshold, PPDT)
研究概览
简要总结
Primary aim: examine a possible connection between cigarette smoking, disease activity and perceived pain in patients with rheumatoid arthritis.
Secondary aim: Evaluate cardiovascular risk in patients with rheumatoid arthritis.
详细描述
The study will recruit patients with rheumatoid arthritis (age 20-60 years) at rheumatology clinics in Västra Götaland. All patients meeting the inclusion criteria will be informed of the study in a letter and later contacted by the study coordinator and if interested booked for a study visit at the rheumatology clinic. At the study visit the patients will meet with rheumatologist for clinical examination of their joints and tenderpoints. An algometer is used for objective quantification of the patients pain sensitivity. Questionnaire regarding medical treatment, other diseases, smoking habits, subjective pain, fatigue, anxiety and depression, ability to work and ability to perform everyday activities are filled out by the patient.
Height, weight, blood pressure, blood, urine and fat biopsy will be collected for analyse.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20-60 years diagnosed with rheumatoid arthritis
排除标准
- •Other serious physical or mental illness, lack of knowledge in Swedish language making answering the questionnaires impossible
结局指标
主要结局
Pain sensitivity (Pressure Pain Detection Threshold, PPDT)
时间窗: At patient enrollment/study visit
Difference in pain sensitivity in smoking vs non-smoking RA-patients. Testing of of all patients' pressure pain detection threshold (PPDT), i-e pain sensitivity is performed by trained personnel, using an algometer. The algometer is placed bilaterally on the nail of the thumb and on the second metatarsophalangeal joint (MTP2), giving a total of four measured points. A progressively increasing pressure is applied with the algometer and the patients are carefully instructed to signal as soon as the pressure sensation turns into pain (not to withstand the pain) and the algometer is removed. The amount of applied force shown in kPa in the display is reported as the PPDT. The measurements are performed twice for each point and an average value is calculated as the patients' pain sensitivity threshold/pressure pain detection threshold.
Cardiovascular risk
时间窗: At patient enrollment/study visit
Difference in cardiovascular risk (Framingham score) in smoking vs non-smoking RA-patients The Framingham risk score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual calculated on the basis of the following: Age Gender Total cholesterol HDL cholesterol Smoker Diabetes Systolic blood pressure Treatment for high blood pressure
Subjective pain perception (VAS)
时间窗: At patient enrollment/study visit
Difference in pain perception in smoking vs non-smoking RA-patients Subjective pain perception is registered by self-reported estimation of pain on a visual analogue scale (VAS) of 100 mm concerning the week preceding the study.
Disease activity score (DAS 28)
时间窗: At patient enrollment/study visit
Difference in disease activity score (DAS 28) in smoking vs non-smoking RA-patients Disease activity, DAS28, is calculated using a specific formula based on: number of painful joints out of 28 joints examined number of swollen joints out of 28 joints examined erythrocyte sedimentation rate (ESR) or C reactive protein (CRP) patient's global assessment of disease activity on a 100 mm visual analogue scale (VAS) DAS thresholds: DAS28 lower than 2.6: remission DAS28 below 3.2: low disease activity DAS28 over 3.2 and under 5.1: moderate disease activity DAS28 above 5.1: high disease activity
次要结局
未报告次要终点