RT Journal Article SR Electronic T1 Pain mechanisms and ultrasonic inflammatory activity as prognostic factors in patients with psoriatic arthritis: protocol for a prospective, exploratory cohort study JF BMJ Open JO BMJ Open FD British Medical Journal Publishing Group SP e010650 DO 10.1136/bmjopen-2015-010650 VO 6 IS 4 A1 Pil Højgaard A1 Robin Christensen A1 Lene Dreyer A1 Philip Mease A1 Maarten de Wit A1 Lone Skov A1 Bente Glintborg A1 Anton Wulf Christensen A1 Christine Ballegaard A1 Henning Bliddal A1 Kristine Bukhave A1 Else Marie Bartels A1 Kirstine Amris A1 Karen Ellegaard A1 Lars Erik Kristensen YR 2016 UL http://bmjopen.bmj.com/content/6/4/e010650.abstract AB Introduction Persistent pain is a major concern for patients with psoriatic arthritis (PsA). Pain may be due to inflammatory activity or augmented central pain processing. Unawareness of the origin and mechanisms of pain can lead to misinterpretation of disease activity (by composite scores) and erroneous treatments. Ultrasonography (US) is a highly sensitive method to detect tissue inflammation. Evaluating pain mechanisms in relation to US measures may prove valuable in predicting response to treatment in PsA.Aims To study the association and prognostic value of pain mechanisms, ultrasonic activity and clinical outcomes in patients with PsA who intensify antirheumatic treatment.Methods and analyses 100 participants >18 years of age with PsA who initiate or switch antirheumatic treatment (biologicals and/or conventional synthetic disease-modifying antirheumatic drugs (DMARDs)) will be prospectively recruited from outpatient clinics in Copenhagen. All data (demographics, clinical, imaging, blood samples and patient-reported outcomes) will be collected at baseline and after 4 months. Pain is assessed by the PainDETECT Questionnaire, Visual Analogue Scale for pain, Swollen to Tender Joint Count Ratio, Widespread Pain Index and tender point examination. The association between pain variables and clinical/US characteristics will be described by correlation analyses. The predictive value of pain measures and baseline US scores on treatment response will be analysed with regression models. Outcomes are composite and clinical, as well as patient reported.Ethics and dissemination The study is approved by the ethics committee of the Capital Region of Denmark (H-15009080) and has been designed in cooperation with patient research partners. The study is registered at clinicaltrials.gov (number NCT02572700). Results will be disseminated through publication in international peer-reviewed journals.Trial registration number NCT02572700, Pre-results.