Clinical trial NCT06718569: Pain in Inflammatory Joint Diseases
Official title: Advancing the Understanding of Pain Mechanisms in Inflammatory Arthritis Towards Precision Pain Management
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Arthritis
Arthritis, Juvenile Idiopathic
Arthritis,Rheumatoid
Arthritis, Reactive
Arthritis, Psoriatic
Spondyloarthritis (SpA)
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2024-12-05
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of men and women (\>18 years of age at screening) who are enrolled in the Nor-DMARD register and give their consent to also participate in this sub-study.

We will not have other inclusion and exclusion criteria than those that are already part of the Nor-DMARD register. This means that all patients who are being enrolled in the Nor-DMARD register will be asked to be part of this sub-study.

Brief summary: Our primary objective is to better understand the etiology and consequences of chronic paint by using an explorative approach to identify phenotypes and endotypes of patients with inflammatory arthritis, with a special focus on central sensitization and cognitive functioning as a key element in chronic pain. We will also examine the risk factors and clinical impact of these factors on pain, disease activity and treatment effects in a longitudinal study of patients with inflammatory joint disesases.


Eligibility criteria: Inclusion Criteria:

* All patients who initiate or switch biological or targeted synthetic DMARDs

Exclusion Criteria:

* None

Primary outcomes:
measure: PROMIS Pain Interference - Short Form 8a
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Social network
timeFrame: Baseline
measure: Gender role perception
timeFrame: Baseline
measure: Arthritis Self-Efficacy Scale (ASES)
timeFrame: Baseline
measure: Pain Catastrophizing Scale (PSC)
timeFrame: Baseline
measure: Douleur Neuropathique 4 (DN4)
timeFrame: Baseline and 3 months
measure: Painful joint count (Homunculus)
timeFrame: Baseline and 3 months
measure: Patient Health Questionnaire (PHQ)
timeFrame: Baseline
measure: General Anxiety Disorder Questionnaire (GAD-7)
timeFrame: Baseline
measure: Psoriatic Arthritis Impact of Disease (PsAID)
timeFrame: Baseline
measure: MetaCognitions Questionnaire 30* (MCQ-30)
timeFrame: Baseline
measure: Pain Metacognition Questionnaire (PMQ)
timeFrame: Baseline
measure: Everyday Memory Questionnaire - revised (EMQ)
timeFrame: Baseline
measure: Stanford Expectation of Treatment Scale (SETS)
timeFrame: Baseline
measure: Gender Role Expectations of Pain (GREP)
timeFrame: Baseline
measure: American College of Rheumatology (ACR) criteria for fibromyalgia
timeFrame: Baseline
measure: Cambridge Neuropsychological Test Automated Battery (CANTAB)
timeFrame: Baseline
measure: Height and weight
timeFrame: Baseline
measure: Hand preference
timeFrame: Baseline
measure: Quantitative sensory testing (QST)
timeFrame: Baseline, 3 months
measure: Biobank
timeFrame: Baseline
Other outcomes:
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