Pain Mechanisms and Ultrasonographic Disease Activity in Psoriatic Arthritis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 100
Summary
- Conditions
- Healthy Controls
- Psoriasis
- Psoriatic Arthritis
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 100 years
- Gender
- Both males and females
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, comorbidities an...
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, comorbidities 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, a follow up visit after 4 months and yearly thereafter. Examinations will be performed at all time points (except stated otherwise) and include: Assessment of pain mechanisms by clinical evaluation (swollen/tender joint ratio, tender points) and pain questionnaires (widespread pain index, PainDETECT). Ultrasonography of joints and entheses by two trained assessors Clinical examination of all psoriatic manifestations Interview and questionnaires regarding lifestyle, comorbidity status, function, quality of life and the impact of psoriatic manifestations. Blood samples for standard rheumatic monitoring and biobank X-ray of hands and feet (only at baseline) AMPS test (assessment of motor and process skills) will be performed and interpreted by an certified ergo therapist (only at baseline visit and at 34-months follow-up and oly for the first included 20 PsA patients) Clinical as well as patient-reported and observer-based outcomes will be described for the overall study population and the prognostic influence of US, comorbidities, 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. We will compare baseline data including pain, fatigue, work, life style and comorbidity status of PsA patients before initiating new treatment with patients with skin psoriasis without arthritis and healthy controls
Tracking Information
- NCT #
- NCT02572700
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Lars Erik Kristensen, MD, Ph.D The Parker Institute, Frederiksberg and Bispebjerg Hospital, Frederiksberg, Denmark