Assessing Pain by the painDETECT Questionnaire (PDQ)

NCT06402396 | Active Not Recruiting

• 1 other identifier: DANBIO PDQ
• Study Type: observational
• Target: 7,056
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Inflammatory Arthritis; Spondylarthropathies; Rheumatoid Arthritis; Psoriatic Arthritis

Keywords

Drug survival; Pain phenotypes; PainDETECT Questionnaire; Inflammatory Arthritis

Outcome Measures

Primary Outcomes (1)

• Differences in bDMARDs drug retention rates

  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.

  From baseline to 5 years followup

Secondary Outcomes (23)

• Differences in Patient acceptable symptom state (Pass)

  From baseline to 5 years followup

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

  From baseline to 5 years followup

• Differences in TenderJoint Count (TJC, 0-28)

  From baseline to 5 years followup

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

  From baseline to 5 years followup

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

  From baseline to 5 years followup

Study Arms (2)

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)

Drug: bDMARDS

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)

Drug: bDMARDS

Interventions

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.

Neuropathic pain phenotype; Non-Neuropathic pain phenotype

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All Patients registered in DANBIO, having inflammatory arthritis (Specific diagnoses include RA, PsA and other SpA) and at time of the PDQ assessment and up to 4 months thereafter being on ongoing bDMARDs treatment or on switch of bDMARD treatment.

You may qualify if:

• 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.

You may not qualify if:

• \- Missing answer to PDQ

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead

MeSH Terms

Conditions

Arthritis; Spondylarthropathies; Arthritis, Rheumatoid; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Study Officials

• Kirstine Amris, MD, DMSc

  Bispebjerg and Frederiksberg Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post doctoral researcher

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 7, 2024
• Study Start: January 1, 2013
• Primary Completion: December 1, 2019
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share