Effect of Smoking on Pain and Atherosclerosis in Patients With Rheumatoid Arthritis

Active, not recruiting

• Conditions: Atherosclerosis; Pain; Rheumatoid Arthritis

• Registration Number: NCT03449589
• Lead Sponsor: Vastra Gotaland Region

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2018-02-07
• Study First Submitted QC: 2018-02-27
• Study First Posted: 2018-02-28
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-04
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Patients aged 20-60 years diagnosed with rheumatoid arthritis

Exclusion Criteria

• Other serious physical or mental illness, lack of knowledge in Swedish language making answering the questionnaires impossible

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain sensitivity (Pressure Pain Detection Threshold, PPDT)	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	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)	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)	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

Trial Locations

Locations (1)

Dept of Rheumatology and Inflammation research; 🇸🇪 Gothenburg, Sweden