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NCT04862520

Prognostic Factors for Work Disability in Patients With Chronic Widespread Pain and Fibromyalgia.

Status unknown Last updated 2 August 2022
What this trial tests

trial in Chronic Widespread Pain in 1,000 participants. Status unknown.

Timeline
1 January 2018
Primary endpoint
1 December 2024
1 December 2024

Quick facts

Lead sponsorFrederiksberg University Hospital
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment1,000
Start date1 January 2018
Primary completion1 December 2024
Estimated completion1 December 2024
Sites1 location across Denmark

Conditions studied

Sponsor

Frederiksberg University Hospital

Who can join

18 and older, any sex, with Chronic Widespread Pain or Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Prognostic factors for work disability in patients with chronic widespread pain and fibromyalgia: protocol for a cohort study.
    Duhn PH, Locht H, Wæhrens EE, Christensen R, et al · · 2021 · PMID 34937720 · DOI 10.1136/bmjopen-2021-052919

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Other recruiting trials for Chronic Widespread Pain

Currently open trials in the same condition.

Other Frederiksberg University Hospital trials

Trials by the same sponsor.

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