Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402396
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-05-02
Brief Title:
Assessing Pain by the painDETECT Questionnaire PDQ
Sponsor:
University Hospital Bispebjerg and Frederiksberg
Organization:
University Hospital Bispebjerg and Frederiksberg
Study Overview
Official Title:
Assessing Pain by the painDETECT Questionnaire PDQ to Evaluate Drug Retention in Patients With Inflammatory Arthritis A Danish Nationwide Prospective DANBIO Registry Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 ie 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
The aim of this study is to examine the association between drug retention of biological DMARDs bDMARDs and the PDQ pain classification categories ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None