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

Pain Clinical Trial

— RAsmo  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03449589
• Other study ID #: RÖK
• Status: Active, not recruiting
• Start date: November 2011
• Est. completion date: November 2025

Study information

• Verified date: May 2022
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Atherosclerosis
• Pain
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Sweden	Dept of Rheumatology and Inflammation research	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease activity score (DAS 28)	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	At patient enrollment/study visit
Primary	Pain sensitivity (Pressure Pain Detection Threshold, PPDT)	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.	At patient enrollment/study visit
Primary	Subjective pain perception (VAS)	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.	At patient enrollment/study visit
Primary	Cardiovascular risk	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	At patient enrollment/study visit