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

NCT04862520 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2022-08-02

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Widespread Pain
  • Fibromyalgia

Sponsors & Collaborators

  • Frederiksberg University Hospital

    lead OTHER

Principal Investigators

  • Pernille H. Duhn, dr. · Parker Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2024-12-01
Completion
2024-12-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04862520 on ClinicalTrials.gov