Effect of Smoking on Pain and Atherosclerosis in Patients With Rheumatoid Arthritis (RAsmo)
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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
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Gothenburg, Suécia
- Dept of Rheumatology and Inflammation research
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Smokers
RA patients currently smoking
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Former smokers
RA patients who previously smoked
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Non smokers
Non smoking RA patients
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Disease activity score (DAS 28)
Prazo: At patient enrollment/study visit
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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
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Pain sensitivity (Pressure Pain Detection Threshold, PPDT)
Prazo: At patient enrollment/study visit
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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.
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At patient enrollment/study visit
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Subjective pain perception (VAS)
Prazo: At patient enrollment/study visit
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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
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Cardiovascular risk
Prazo: At patient enrollment/study visit
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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
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Lyngfelt LI, Erlandsson MC, Nadali M, Hedjazifar S, Pullerits R, Andersson KM, Brembeck P, Silfversward ST, Smith U, Bokarewa MI. Impact of the Uncoupling Protein 1 on Cardiovascular Risk in Patients with Rheumatoid Arthritis. Cells. 2021 May 7;10(5):1131. doi: 10.3390/cells10051131.
- Nadali M, Lyngfelt L, Erlandsson MC, Silfversward ST, Andersson KME, Bokarewa MI, Pullerits R. Low Soluble Receptor for Advanced Glycation End Products Precedes and Predicts Cardiometabolic Events in Women With Rheumatoid Arthritis. Front Med (Lausanne). 2021 Jan 28;7:594622. doi: 10.3389/fmed.2020.594622. eCollection 2020.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RÖK
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