TY - JOUR

T1 - Pain mechanisms and ultrasonic inflammatory activity as prognostic factors in patients with psoriatic arthritis

T2 - protocol for a prospective, exploratory cohort study

AU - Højgaard, Pil

AU - Christensen, Robin

AU - Dreyer, Lene

AU - Mease, Philip

AU - de Wit, Maarten

AU - Skov, Lone

AU - Glintborg, Bente

AU - Christensen, Anton Wulf

AU - Ballegaard, Christine

AU - Bliddal, Henning

AU - Bukhave, Kristine

AU - Bartels, Else Marie

AU - Amris, Kirstine

AU - Ellegaard, Karen

AU - Kristensen, Lars Erik

N1 - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

PY - 2016/4/15

Y1 - 2016/4/15

N2 - 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.

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.

KW - Antirheumatic Agents

KW - Arthritis, Psoriatic

KW - Disease Progression

KW - Female

KW - Humans

KW - Inflammation

KW - Male

KW - Pain

KW - Pain Measurement

KW - Prognosis

KW - Prospective Studies

KW - Remission Induction

KW - Severity of Illness Index

KW - Treatment Outcome

KW - Journal Article

KW - Research Support, Non-U.S. Gov't

U2 - 10.1136/bmjopen-2015-010650

DO - 10.1136/bmjopen-2015-010650

M3 - Journal article

C2 - 27084281

VL - 6

SP - e010650

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 4

ER -