Last updated on October 2019

Pain Mechanisms and Ultrasonographic Disease Activity in Psoriatic Arthritis

Brief description of study

The objective of the study is to investigate pain mechanisms, ultrasonographic (US) inflammatory activity and association between these conditions in patients with psoriatic arthritis (PsA) intensifying anti-rheumatic treatment. Further, to assess the predictive value of baseline pain profile and US joint/entheses activity on treatment outcome after 4 months.

Detailed Study Description

Patients with psoriatic arthritis, who initiate or switch anti-rheumatic treatment (conventional disease modifying drugs or biologic drugs) in routine care due to an active disease state, will be enrolled in the observational study.

The overall aim is to investigate pain mechanisms and US psoriatic changes and elucidate if these factors - independently or by interaction - influence treatment response after 4 months. Patients will have a baseline visit and a follow up visit after 4 months. Examinations will be performed at both time points and include:

  1. Assessment of pain mechanisms by clinical evaluation (swollen/tender joint ratio, tender points) and pain questionnaires (widespread pain index, PainDETECT).
  2. Ultrasonography of joints and entheses by two trained assessors
  3. Clinical examination of all psoriatic manifestations
  4. Interview and questionnaires regarding lifestyle, co-morbidity, function, quality of life and the impact of psoriatic manifestations.
  5. X-ray of hands and feet
  6. Blood samples
  7. AMPS test (assessment of motor and process skills) will be performed and interpreted by an certified ergo therapist.

Clinical as well as patient-reported and observer-based outcomes will be described for the overall study population and the prognostic influence of US- and pain mechanisms will be analysed. Subsequently, the analyses will be repeated for certain subgroups of patients (e.g., conventional drug therapy vs. biologic drug intervention) in an exploratory manner.

Clinical Study Identifier: NCT02572700

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