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

NCT04862520 | Unknown

• 1 other identifier: PDH4
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Work status on the overall cohort

  To reveal prognostic factors, among the cohort of CWP patients, that are associated with the primary endpoint work status (employed and working vs not working) assessed after 3- years.

  3 years

Secondary Outcomes (2)

• Work status on those employed and working at baseline

  3 years

• Work status on those not working at baseline

  3 years

Eligibility Criteria

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

Study Population

Chronic widespread pain (CWP) is prevalent in the background population with an estimated prevalence of about 10% and represents a major clinical challenge due to the complexity of the disease. Apart from pain and other centrally mediated symptoms, CWP is strongly associated with disability affecting activities of daily living (ADL), incapacity for normal employment and poor social participation. Fibromyalgia (FM) is the best characterised subset of patients presenting with CWP and is by many considered to represent the upper end of a pain severity spectrum, i.e. associated with greater disease burden and higher levels of disability, in comparison to patients with CWP not fulfilling FM disease criteria or more localized pain conditions.

You may qualify if:

• participants must:
• be over 18 years of age
• able to understand and read Danish
• have retrievable data in the DANFIB registry

You may not qualify if:

• no consent
• do not read and understand Danish
• non-retrievable data in the DANFIB registry
• any form of pension.

Sponsors & Collaborators

• Frederiksberg University Hospital: lead

Study Sites (1)

Frederiksberg Hospital

Frederiksberg, 2000, Denmark

RECRUITING

Related Publications (1)

• Duhn PH, Locht H, Waehrens EE, Christensen R, Thielen K, Henriksen M, Kristensen LE, Bliddal H, Amris K. Prognostic factors for work disability in patients with chronic widespread pain and fibromyalgia: protocol for a cohort study. BMJ Open. 2021 Dec 22;11(12):e052919. doi: 10.1136/bmjopen-2021-052919.

  PMID: 34937720 DERIVED

MeSH Terms

Conditions

Chronic Pain; Fibromyalgia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Pernille H. Duhn, dr.

  Parker Institute

  STUDY CHAIR

Central Study Contacts

Pernille H. Duhn, dr.

CONTACT

+4538164158; pernille.hurup.duhn@regionh.dk

Kirstine Amris, dr.med.

CONTACT

+4538164158; kirstine.amris@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: April 28, 2021
• Study Start: January 1, 2018
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 2, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)