Assessing Pain by the painDETECT Questionnaire (PDQ)

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

7056 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2027-01-01

Brief Summary

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Prospective cohort study using drug survival rates to assess the predictive value of the PDQ when used to classify patients into a non-neuropathic pain phenotype group (score \<13) or a neuropathic pain phenotype group (score ≥13)

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Detailed Description

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The original painDETECT questionnaire (PDQ) DANBIO study was a survey among all DANBIO users having an arthritis diagnosis 'Pain and pain mechanisms in patients with inflammatory arthritis: A Danish nationwide cross-sectional DANBIO registry survey'. The PDQ was implemented onto the DANBIO touch screens for a period of 6 months in 2013-14 and data from more than 7000 individual patients were collected. The overall background for the study was that central pain mechanisms may be prominent in subsets of patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and other spondyloarthritis (SpA). The study showed that approximately 50 % of patients experienced significant pain levels and that a high PDQ score was associated with higher levels of pain and DAS28 but not with markers of inflammatory activity such as CRP and swollen joint count. Furthermore, indications of more frequent bio-switch in the PDQ groups showing neuropathic pain features were found.

The aim of this study is to examine the association between drug retention of biological DMARDs (bDMARDs) and the PDQ pain classification categories (i.e. non-neuropathic vs. neuropathic features) and to investigate whether this categorization is predictive of drug retention and changes in clinical outcomes over a 5-year period.

Conditions

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Inflammatory Arthritis Spondylarthropathies Rheumatoid Arthritis Psoriatic Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-Neuropathic pain phenotype

Based on the PainDETECT Questionnaire (PDQ), patients scoring \<13 will be classified as "exposed" as they are considered a group with non-neuropathic pain (Non-neuropathic pain phenotype)

bDMARDS

Intervention Type DRUG

Patients at time of the PDQ assessment and up to 4 months thereafter being on ongoing bDMARDs treatment or on switch of bDMARD treatment.

Neuropathic pain phenotype

Based on the PainDETECT Questionnaire (PDQ), patients scoring ≥13 will be classified as "un-exposed" as they are considered a group with neuropathic pain (neuropathic pain phenotype)

bDMARDS

Intervention Type DRUG

Patients at time of the PDQ assessment and up to 4 months thereafter being on ongoing bDMARDs treatment or on switch of bDMARD treatment.

Interventions

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bDMARDS

Patients at time of the PDQ assessment and up to 4 months thereafter being on ongoing bDMARDs treatment or on switch of bDMARD treatment.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Registered in DANBIO
* Having inflammatory arthritis (Specific diagnoses include RA, PsA and other SpA)
* At time of the PDQ assessment and up to 4 months thereafter being on ongoing bDMARDs treatment or on switch of bDMARD treatment.