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NCT Number: NCT06402396

Assessing Pain by the painDETECT Questionnaire (PDQ)

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Inflammatory Arthritis Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Autoimmune Diseases Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Psoriatic Arthritis Rheumatic Diseases Rheumatoid Arthritis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • Missing answer to PDQ

Treatment and study plan

bDMARDS

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.

Primary outcomes

  1. Differences in bDMARDs drug retention rates

    Time frame: From baseline to 5 years followup

    Drug retention rates will be described using Kapan-Mayer curves. Differences in changes in bDMARDs drug retention rates over 5 years between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.

Secondary outcomes

  1. Differences in Patient acceptable symptom state (Pass)

    Time frame: From baseline to 5 years followup

    Differences in changes in patients having an acceptable symptom state at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.

    The PASS is defined as the highest symptom level below which a patient considers his/her symptom state as acceptable. it is answered via a yes or a no.

  2. Differences in Swollen Joint Count (SJC, 0-28)

    Time frame: From baseline to 5 years followup

    Differences in changes in SJC 0-28 at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.

  3. Differences in TenderJoint Count (TJC, 0-28)

    Time frame: From baseline to 5 years followup

    Differences in changes in TJC 0-28 at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.

  4. Differences in Doctors' global assessment (VAS 0-100 mm.)

    Time frame: From baseline to 5 years followup

    Differences in changes in Doctors' global assessment 0-100 at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.

  5. Differences in VAS pain (0-100 mm) (Higher indicates more pain)

    Time frame: From baseline to 5 years followup

    Differences in changes in VAS pain (0-100 mm) at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.

  6. Differences in VAS fatigue (0-100 mm) (Higher indicates more fatigue)

    Time frame: From baseline to 5 years followup

    Differences in changes in VAS fatigue (0-100 mm) at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.

  7. Differences in VAS global (0-100 mm) (Higher indicates more global disease activity)

    Time frame: From baseline to 5 years followup

    Differences in changes in VAS global (0-100 mm) at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.

  8. Differences in HAQ (0-3) (higher indicates a more impaired functional level)

    Time frame: From baseline to 5 years followup

    Differences in changes in HAQ (0-3) at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire. 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section, i.e. if one question is scored 1 and another 2, then the score for the section is 2. In addition, if an aide or device is used or if help is required from another individual, then the minimum score for that section is 2. If the section score is already 2 or more then no modification is made. The 8 scores of the 8 sections are summed and divided by 8. The result is the DI disability index index. In the event that one section is not completed by a subject then the summed score would be divided by 7.

  9. Differences in CRP (mg/L)

    Time frame: From baseline to 5 years followup

    Differences in changes in CRP (mg/L) at 5 years follow-up between patients with a non-neuropathic phenotype and patients with a neuropathic pain phenotype based on the PainDETECT Questionnaire.

  10. The prognostic value of pain phenotype classification by PainDETECT (PDQ) on RA diagnosis.

    Time frame: Measured at baseline

    The probability of having an RA diagnosis when having a non-neuropathic pain phenotype.

  11. The prognostic value of pain phenotype classification by PainDETECT (PDQ) on PsA diagnosis.

    Time frame: Measured at baseline

    The probability of having an PsA diagnosis when having a non-neuropathic pain phenotype.

  12. The prognostic value of pain phenotype classification by PainDETECT (PDQ) on SpA diagnosis.

    Time frame: Measured at baseline

    The probability of having an SpA diagnosis when having a non-neuropathic pain phenotype.

  13. The prognostic value of pain phenotype classification by PainDETECT (PDQ) on number of bioswitches.

    Time frame: Measured at baseline

    The probability of having bioswitches when having a non-neuropathic pain phenotype.

  14. The prognostic value of pain phenotype classification by PainDETECT (PDQ) on Swollen Joint Count (SJC, 0-28)

    Time frame: Measured at baseline

    The probability of having less swollen joints on the SJC 0-28 when having a non-neuropathic pain phenotype.

  15. The prognostic value of pain phenotype classification by PainDETECT (PDQ) on TenderJoint Count (TJC, 0-28)

    Time frame: Measured at baseline

    The probability of having less tender joints on the TJC 0-28 when having a non-neuropathic pain phenotype.

  16. The prognostic value of pain phenotype classification by PainDETECT (PDQ) on Doctors' global assessment (VAS: 0-100 mm)

    Time frame: Measured at baseline

    The probability of having a favourable score on Doctors' global assessment (VAS: 0-100 mm) when having a non-neuropathic pain phenotype.

  17. The prognostic value of pain phenotype classification by PainDETECT (PDQ) on PASS (y/n)

    Time frame: Measured at baseline

    The probability of having an acceptable symptom state (PASS) when having a non-neuropathic pain phenotype.

  18. The prognostic value of pain phenotype classification by PainDETECT (PDQ) on Patient acceptable symptom score (PASS (y/n))

    Time frame: Measured at baseline

    The probability of having a favourable score on Patient acceptable symptom score (PASS) (yes/no) when having a non-neuropathic pain phenotype.

  19. The prognostic value of pain phenotype classification by PainDETECT (PDQ) on VAS pain (0-100 mm)

    Time frame: Measured at baseline

    The probability of having a favourable score on VAS pain (0-100 mm) when having a non-neuropathic pain phenotype.

  20. The prognostic value of pain phenotype classification by PainDETECT (PDQ) on VAS fatigue (0-100 mm)

    Time frame: Measured at baseline

    The probability of having a favourable score on VAS fatigue (0-100 mm) when having a non-neuropathic pain phenotype.

  21. The prognostic value of pain phenotype classification by PainDETECT (PDQ) on VAS global (0-100 mm)

    Time frame: Measured at baseline

    The probability of having a favourable score on VAS global (0-100 mm) when having a non-neuropathic pain phenotype.

  22. The prognostic value of pain phenotype classification by PainDETECT (PDQ) on the Health assessment questionnaire (HAQ (0-3))

    Time frame: Measured at baseline

    The probability of having a favourable score on HAQ (0-3 mm) when having a non-neuropathic pain phenotype.

  23. The prognostic value of pain phenotype classification by PainDETECT (PDQ) on C- reactive protein (CRP (mg/L))

    Time frame: Measured at baseline

    The probability of having a favourable CRP when having a non-neuropathic pain phenotype.

Sponsors and collaborators

Lead sponsor

University Hospital Bispebjerg and Frederiksberg

Other

Registry information

Official study title

Assessing Pain by the painDETECT Questionnaire (PDQ) to Evaluate Drug Retention in Patients With Inflammatory Arthritis: A Danish Nationwide Prospective DANBIO Registry Study

Important dates

Study start
2013
Primary completion
2019
Study completion
2027
First posted
May 7, 2024
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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