Chronic Widespread PainNCT04862520
Prognostic Factors for Work Disability in Patients With Chronic Widespread Pain and Fibromyalgia.
An observational study of Chronic Widespread Pain and Fibromyalgia, run by Frederiksberg University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Widespread Pain, Fibromyalgia
- How many people
- 1,000 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2018to 1 Dec 2024
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- participants must:
- be over 18 years of age
- able to understand and read Danish
- have retrievable data in the DANFIB registry
Who cannot join
- no consent
- do not read and understand Danish
- non-retrievable data in the DANFIB registry
- any form of pension.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Frederiksberg Hospital
Frederiksberg, 2000
Pernille H. Duhn, Dr., +4538164158, pernille.hurup.duhn@regionh.dk
About this study
Official title: Prognostic Factors for Work Disability in Patients With Chronic Widespread Pain and Fibromyalgia: Protocol for a Cohort Study
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.
Read more
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.
Read the detailed description
By using prognostic factor research, the purpose is to understand and improve future outcomes in patients with CWP. Identification of prognostic factors for long-term functional outcomes, including work disability, could assist tailoring and timing the therapeutic decision for specific patients and potentially optimise functional outcomes compared with offering standardised (i.e. ignorant) intervention programs to patients with CWP.
The results from this cohort study are anticipated to contribute with relevant knowledge that may be used to guide future intervention matching and delivery of stratified interventions based on prognostic classification.
Study design:
The study is designed as a clinical cohort study enabling multivariable logistic regression modelling of data from the large Danish DANFIB cohort of CWP patients with the primary aim assessed after 3- years.
Setting:
Data collection takes place in a specialised clinical care setting at the diagnostic unit at Department of Rheumatology, Frederiksberg Hospital. Here patients presenting with CWP, either as their primary pain problem or secondary to other established rheumatic disease, have been offered clinical assessment and screening for CWP since 1st of January 2018.
The electronic data collection is accessed via touchscreens and data are exported to a designated clinical research database (the DANFIB registry). Data extracted from electronic patient files, including findings at clinical examination (manual TP count), are also integrated into the DANFIB registry. A protocol outlining the content and objectives of the DANFIB registry can be accessed online.The DANFIB registry will serve as point of departure for the current cohort study.
Participants:
The first 1,000 patients consecutively registered in the DANFIB registry with CWP independent of working status. Participant inclusion is expected to be completed by December 2021. Informed consent will be obtained for all participants when registered in the DANFIB registry.
Data sources:
Baseline demographics, clinical characteristics and individual labour market status assessed at baseline will be extracted from the DANFIB registry. Data on the primary endpoint work status ("employed and working" or "not working") at baseline and again 3- years from baseline will be extracted from the Integrated Laboure Market Database at Statistics Denmark and the nationwide Danish DREAM database.
- Conditions
- Chronic Widespread Pain, Fibromyalgia
- Medical subject headings
- Chronic Pain, Fibromyalgia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (2)
Work status on those employed and working at baseline
Identification of prognostic factors for work status (employed and working vs not working) after 3- years in patients with CWP, who are employed and working at baseline.
Measured: 3 years
Work status on those not working at baseline
III. identification of prognostic factors for work status (employed and working vs not working) after 3- years in patients with CWP, who are not working at baseline.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 Jan 2018
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Widespread PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Frederiksberg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henning Bliddal, Frederiksberg University Hospital
- Investigators
- Pernille H. Duhn, dr., Study chair, Parker Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862520
- Sponsor's protocol ID
- PDH4
- Status last verified
- Aug 2022
- First submitted
- 23 Apr 2021
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34937720
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors for Work Disability in Patients With Chronic Widespread Pain and Fibromyalgia: Protocol for a Cohort Study
- ClinicalTrials.gov ID
- NCT04862520
- Acronym / sponsor ID
- PDH4
- Conditions
- Chronic Widespread Pain, Fibromyalgia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Frederiksberg University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
By using prognostic factor research, the purpose is to understand and improve future outcomes in patients with CWP. Identification of prognostic factors for long-term functional outcomes, including work disability, could assist tailoring and timing the therapeutic decision for specific patients and potentially optimise functional outcomes compared with offering standardised (i.e. ignorant) intervention programs to patients with CWP.
The results from this cohort study are anticipated to contribute with relevant knowledge that may be used to guide future intervention matching and delivery of stratified interventions based on prognostic classification.
Study design:
The study is designed as a clinical cohort study enabling multivariable logistic regression modelling of data from the large Danish DANFIB cohort of CWP patients with the primary aim assessed after 3- years.
Setting:
Data collection takes place in a specialised clinical care setting at the diagnostic unit at Department of Rheumatology, Frederiksberg Hospital. Here patients presenting with CWP, either as their primary pain problem or secondary to other established rheumatic disease, have been offered clinical assessment and screening for CWP since 1st of January 2018.
The electronic data collection is accessed via touchscreens and data are exported to a designated clinical research database (the DANFIB registry). Data extracted from electronic patient files, including findings at clinical examination (manual TP count), are also integrated into the DANFIB registry. A protocol outlining the content and objectives of the DANFIB registry can be accessed online.The DANFIB registry will serve as point of departure for the current cohort study.
Participants:
The first 1,000 patients consecutively registered in the DANFIB registry with CWP independent of working status. Participant inclusion is expected to be completed by December 2021. Informed consent will be obtained for all participants when registered in the DANFIB registry.
Data sources:
Baseline demographics, clinical characteristics and individual labour market status assessed at baseline will be extracted from the DANFIB registry. Data on the primary endpoint work status ("employed and working" or "not working") at baseline and again 3- years from baseline will be extracted from the Integrated Laboure Market Database at Statistics Denmark and the nationwide Danish DREAM database.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- be over 18 years of age
- able to understand and read Danish
- have retrievable data in the DANFIB registry
Key exclusion criteria (4 listed)
- no consent
- do not read and understand Danish
- non-retrievable data in the DANFIB registry
- any form of pension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Work status on the overall cohort
Time frame: 3 years
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.
2 secondary outcomes
Work status on those employed and working at baseline
Time frame: 3 years
Work status on those not working at baseline
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Derived from this study: PubMed 34937720Duhn 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pernille H. Duhn, dr. study chair
Parker Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Widespread Pain and Fibromyalgia, run by Frederiksberg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pernille H. Duhn, dr. (+4538164158, pernille.hurup.duhn@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work status on the overall cohort (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04862520, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.