Pain Mechanisms and Ultrasonographic Disease Activity in Psoriatic Arthritis
NCT ID: NCT02572700
Last Updated: 2021-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2015-09-30
2025-09-30
Brief Summary
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Detailed Description
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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:
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, comorbidity status, function, quality of life and the impact of psoriatic manifestations.
5. Blood samples for standard rheumatic monitoring and biobank
6. X-ray of hands and feet (only at baseline)
7. 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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with psoriatic arthritis
PsA patients initiating anti-rheumatic treatment in routine care will be included as one group in the observational study. Analyses will be carried out for the overall study population as well as for subgroups (e.g., stratified according to treatment intervention) in an exploratory manner.
Clinical examination, blood sampling, ultrasonic assessment, and questionnaires
Visits include clinical examination, questionnaires (pain, comorbidity, lifestyle, work status) and ultrasonography of joints and entheses, blood samples, and only at baseline x-ray of hands and feet.
Patients with skin psoriasis without arthrits
20 patients with skin psoriasis without arthrits will be included as one group at baseline only. Baseline characteristics including status of pain, fatigue, work, comorbidity and lifestyle factors will be recorded.
Clinical examination, blood sampling, ultrasonic assessment, and questionnaires
Visits include clinical examination, questionnaires (pain, comorbidity, lifestyle, work status) and ultrasonography of joints and entheses, blood samples, and only at baseline x-ray of hands and feet.
Healthy controls
20 healthy controls will be included as one group at baseline only. Baseline characteristics including status of pain, fatigue, work, comorbidity and lifestyle factors will be recorded.
Clinical examination, blood sampling, ultrasonic assessment, and questionnaires
Visits include clinical examination, questionnaires (pain, comorbidity, lifestyle, work status) and ultrasonography of joints and entheses, blood samples, and only at baseline x-ray of hands and feet.
Interventions
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Clinical examination, blood sampling, ultrasonic assessment, and questionnaires
Visits include clinical examination, questionnaires (pain, comorbidity, lifestyle, work status) and ultrasonography of joints and entheses, blood samples, and only at baseline x-ray of hands and feet.
Eligibility Criteria
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Inclusion Criteria
* Peripheral joint involvement.
* Minimum 18 years of age.
* Initiating or switching anti-rheumatic treatment due to active PsA.
* Signing a written informed consent.
Exclusion Criteria
* Peripheral neuropathy
* Demyelinising disease
* Recent stroke
* Other rheumatic inflammatory diseases.
* Oral, intra-articular or intra-muscular glucocorticoids within 3 weeks prior to baseline
* Treatment with centrally acting analgesics (opioids, anti-depressants, anticonvulsants) within 1 week prior to baseline
* Treatment with mild analgesics (non-steroidal anti-inflammatory drugs, acetylsalicylic acid, acetaminophen) within 24 hours prior to baseline
18 Years
100 Years
ALL
Yes
Sponsors
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Frederiksberg University Hospital
OTHER
Responsible Party
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Henning Bliddal
Professor
Principal Investigators
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Lars Erik Kristensen, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
The Parker Institute, Frederiksberg and Bispebjerg Hospital, Frederiksberg, Denmark
Locations
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The Parker Institute, Frederiksberg and Bispebjerg Hospital
Frederiksberg, Copenhagen, Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Skougaard M, Stisen ZR, Jorgensen TS, Egeberg A, Hansen RL, Perez-Chada LM, Mogensen M, Merola JF, Gerwien JG, Kristensen LE. Increased prevalence of sleep disturbance in psoriatic arthritis is associated with inflammatory and non-inflammatory measures. Scand J Rheumatol. 2023 May;52(3):259-267. doi: 10.1080/03009742.2022.2044116. Epub 2022 Mar 18.
Skougaard M, Jorgensen TS, Jensen MJ, Ballegaard C, Guldberg-Moller J, Egeberg A, Christensen R, Benzin P, Stisen ZR, Merola JF, Coates LC, Strand V, Mease P, Kristensen LE. Change in psoriatic arthritis outcome measures impacts SF-36 physical and mental component scores differently: an observational cohort study. Rheumatol Adv Pract. 2021 Nov 2;5(3):rkab076. doi: 10.1093/rap/rkab076. eCollection 2021.
Ballegaard C, Skougaard M, Guldberg-Moller J, Nissen CV, Amris K, Jorgensen TS, Dreyer L, Kristensen LE. Comorbidities, pain and fatigue in psoriatic arthritis, psoriasis and healthy controls: a clinical cohort study. Rheumatology (Oxford). 2021 Jul 1;60(7):3289-3300. doi: 10.1093/rheumatology/keaa780.
Hojgaard P, Ellegaard K, Nielsen SM, Christensen R, Guldberg-Moller J, Ballegaard C, Dreyer L, Mease P, de Wit M, Skov L, Glintborg B, Bliddal H, Bartels EM, Amris K, Kristensen LE. Pain Mechanisms and Ultrasonic Inflammatory Activity as Prognostic Factors in Patients With Psoriatic Arthritis: A Prospective Cohort Study. Arthritis Care Res (Hoboken). 2019 Jun;71(6):798-810. doi: 10.1002/acr.23693. Epub 2019 May 2.
Hojgaard P, Christensen R, Dreyer L, Mease P, de Wit M, Skov L, Glintborg B, Christensen AW, Ballegaard C, Bliddal H, Bukhave K, Bartels EM, Amris K, Ellegaard K, Kristensen LE. Pain mechanisms and ultrasonic inflammatory activity as prognostic factors in patients with psoriatic arthritis: protocol for a prospective, exploratory cohort study. BMJ Open. 2016 Apr 15;6(4):e010650. doi: 10.1136/bmjopen-2015-010650.
Other Identifiers
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H-15009080
Identifier Type: -
Identifier Source: org_study_id
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