Abstract
BackgroundPain and fatigue are persistent problems in people with rheumatoid arthritis. Central sensitisation (CS) may contribute to pain and fatigue, even when treatment has controlled inflammatory disease. This study aims to validate a self-report 8-item questionnaire, the Central Aspects of Pain in Rheumatoid Arthritis (CAP-RA) questionnaire, developed to measure central pain mechanisms in RA, and to predict patient outcomes and response to treatment. A secondary objective is to explore mechanisms linking CS, pain and fatigue in people with RA.Methods/designThis is a prospective observational cohort study recruiting 250 adults with active RA in secondary care. The CAP-RA questionnaire, demographic data, medical history, and patient reported outcome measures (PROMs) of traits associated with central sensitization will be collected using validated questionnaires. Quantitative sensory testing modalities of pressure pain detection thresholds, temporal summation and conditioned pain modulation will be indices of central sensitization, and blood markers, swollen joints and ultrasound scans will be indices of inflammation. Primary data collection will be at baseline and 12 weeks. The test-retest reliability of CAP-RA questionnaire will be determined 1 week after the baseline visit. Pain and fatigue data will be collected weekly via text messages for 12 weeks. CAP-RA psychometric properties, and predictive validity for outcomes at 3 months will be evaluated.DiscussionThis study will validate a simple self-report questionnaire against psychophysical indices of central sensitization and patient reported outcome measures of traits associated with CS in a population of individuals with active RA. The application of this instrument in the clinical environment could provide a mechanism-based stratification tool to facilitate the provision of targeted therapy to individuals with pain and fatigue in RA, alongside treatments that target joint inflammation.Trial registrationClinicaltrials.gov NCT04515589. Date of registration 17 August 2020.
Highlights
Pain and fatigue are persistent problems in people with rheumatoid arthritis
The study is based on the premise that persistent pain in Rheumatoid Arthritis is a (RA), in some people is caused by central mechanisms and that targeted adjuvant treatment provided to this specific population would greatly improve health outcomes in these individuals
Synovitis, is a known cause of RA pain, we will directly measure this with US to ensure that it is documented with sufficient detail and that its contribution to pain and pain prognosis is included within our analyses [67]
Summary
Pain and fatigue are persistent problems in people with rheumatoid arthritis. Central sensitisation (CS) may contribute to pain and fatigue, even when treatment has controlled inflammatory disease. This study aims to validate a self-report 8-item questionnaire, the Central Aspects of Pain in Rheumatoid Arthritis (CAPRA) questionnaire, developed to measure central pain mechanisms in RA, and to predict patient outcomes and response to treatment. Rheumatoid Arthritis is a (RA) chronic autoimmune inflammatory disease affecting hands, feet and other joints. RA typically presents with pain, joint stiffness, and fatigue. It may be associated with extra-articular inflammation affecting, for example, lungs or eyes [1].
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