Prognostic Factors for Work Disability in Patients With Chronic Widespread Pain and Fibromyalgia.
Unknown statusNCT04862520
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Introduction: The association between chronic widespread pain (CWP) and disability is well-established. Although research support large inter-individual differences in functional outcomes, limited studies are available on the socio-economic consequences of offering stratified treatment based on prognostic factors. Identification of predictors of long-term functional outcomes such as work disability as a critical consequence, could assist early and targeted personalised interventions. The primary objective of this cohort study is to identify prognostic factors for the primary endpoint work status (employed and working vs not working) in patients with CWP assessed 3- years from baseline, i.e. at referral for specialist care. Methods and analyses: Data are collected at the diagnostic unit at Department of Rheumatology, Frederiksberg Hospital. The first 1,000 patients \>=18 years of age registered in a clinical research database (DANFIB registry) with CWP either "employed and working" or "not working" will be enrolled. Participants must meet the American College of Rheumatology (ACR) 1990 definition of CWP, i.e. pain in all four body quadrants and axially for more than three months and are additionally screened for fulfilment of criteria for FM. Clinical data and patient-reported outcomes are collected at referral (baseline) through clinical assessment and electronic questionnaires. Data on the primary endpoint work status at baseline and 3- years from baseline will be extracted from the Integrated Labour Market Database, Statistics Denmark and the nationwide Danish DREAM database. Prognostic factor analysis will be based on multivariable logistic regression modelling with the dichotomous work status as dependent variable.
Study details
- Official title
- Prognostic Factors for Work Disability in Patients With Chronic Widespread Pain and Fibromyalgia: Protocol for a Cohort Study
- Conditions
- Sponsor
- Frederiksberg University Hospital
- Start date
- 2018-01-01
- Primary completion
- 2024-12-01
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Denmark
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: participants must: * be over 18 years of age * able to understand and read Danish * have retrievable data in the DANFIB registry Exclusion Criteria: * no consent * do not read and understand Danish * non-retrievable data in the DANFIB registry * any form of pension.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04862520