Musculoskeletal Pain DisorderNCT04196634
Risk Assessment for Prolonged Sickness Absence Due to Musculoskeletal Conditions
An observational study of Musculoskeletal Pain Disorder, run by Oslo Metropolitan University at 1 site in Norway.
Trial summary
Musculoskeletal (MSK) conditions are a leading cause of years lived with disability worldwide and for the last decade they have also been the most common cause of sickness absence and disability pension in Norway. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Pain Disorder
- What is being tested?
- Risk assessment
- How many people
- 560 participants
- Where
- 1 siteNorway
- Study dates
- 1 Nov 2018to Sep 2023
- 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: People on sick leave due to musculoskeletal pain conditions in Norway were invited to participate. Eligible participants had to log on to their personal sickness absence website at the Norwegian Welfare and Labor Administration to be able to see a link to the project.
Who may be able to join
- People older than 18 years on sick leave due to musculoskeletal pain for at least 4 weeks
Who cannot join
- People on sick leave for other pain conditions or diseases
- People not able to read or write Norwegian or English
Trial locations and contacts
1 site in 1 country.
About this study
Musculoskeletal (MSK) conditions are a leading cause of years lived with disability worldwide and for the last decade they have also been the most common cause of sickness absence and disability pension in Norway.
Although most sickness absence is short-termed, a small proportion of people with MSK conditions are on long-term sick leave, contributing to large cost due to disbursement of benefits, productivity loss and extensive use of health care. There is growing evidence that long-term sickness absence is harmful to mental and physical health, with a reduced probability of return to work (RtW) with prolonged sickness absence. Thus, focusing on early RtW in people on sick leave due to MSK conditions is important to reduce the burden on both the individual and the society. However, to provide interventions to reduce the duration of sickness absence to all people on sick leave would require enormous resources. By targeting those at risk of long-term sickness absence, resources may be used differently, e.g. more resource-saving. By using information on modifiable risk factors from simple risk assessment tools, health care providers and other stakeholders may facilitate RtW in a better way.
The overall purposes of this project are 1) to identify the most accurate screening tool to identify people at a high risk of prolonged sickness absence due to a MSK condition, and 2) to investigate severity of MSK health, health-related quality-of-life, health care consumption, and costs across different risk profiles in people on sick leave due to MSK conditions. We will use registered data on sickness absence from 1 year before to 1 year after inclusion in the study.
Read the detailed description
Main aims are:
- To compare the predictive ability of the STarT MSK tool and the ÖMPSQ-SF, and other established risk factors for long-term sickness absence (e.g. symptoms of depression and emotional distress, low motivation for returning to work, low self-efficacy, work expectancies) for identifying prolonged sickness absence at 6- and 12-months follow-up due to MSK conditions
- To develop a prognostic model to predict risk of prolonged sickness absence at 12-month follow-up in people with MSK conditions
- To assess predictors for high costs (productivity loss and health care use) at 6- and 12-months follow-up in people on sick leave due to MSK conditions
The study will also include additional methodological and descriptive aims.
Prior to the data collection we translated and culturally adapted the Keele STarT MSK and MSK-HQ following the Beaton guidelines.
The study is conducted within the Norwegian Welfare and Labor Administration (NAV) system in collaboration with OsloMet - Oslo Metropolitan University. Data on sickness absence from the NAV registry will be retrieved prospectively in the period from study inclusion to 12 months follow-up, and retrospectively 12 months prior to inclusion in the study.
Previous studies show that 30-40% of people with MSK conditions have not RtW after 3 to 12 months. In order to conduct analyses including 15- 20 predictor variables, we aim at including 500-600 people on sick leave due to MSK conditions. As the main outcomes are collected through registries, we do not expect any dropouts.
- Conditions
- Musculoskeletal Pain Disorder
- Being tested
- Risk assessment
- Keywords
- Risk Assessment
- Medical subject headings
- Collagen Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk assessmentOther
People on sick leave due to musculoskeletal conditions will be screened for potential risk factors for prolonged sickness absence. No intervention will be given.
| Study group | Role | What they receive |
|---|---|---|
| People on sick leave | People on sick leave due to musculoskeletal conditions for at least 4 weeks. Receives: Other: Risk assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sickness absence days
Total number of absence days during 12 months of follow-up adjusted for percentage of work and percentage of sickness absence. Register data from the national health and welfare services
Measured: 12 months
Time to sustainable return to work
The time until full sustainable return to work, i.e. at least 4 weeks without relapse during 12 months of follow-up. Register data from the national health and welfare services
Measured: 12 months
Probability of return to work
Probability of working (i.e. not receiving medical benefits) each month during 12 months of follow-up, measured as repeated events. Register data from the national health and welfare services
Measured: 12 months
Proportion who have returned to work
Proportion of people with sustainable return to work (at least 4 weeks) at 12 months. Register data from the national health and welfare services
Measured: 12 months
Health care costs
Use of health care will be collected from public registries including Norwegian Patient Registry (NPR), Municipal Patient and User Registry (KPR) and Control and Payment of Health Refunds (KUHR).
Measured: 12 months
Sickness absence costs
Sickness absence costs will be calculated based on data from the NAV registry
Measured: 12 months
Secondary outcomes (9)
Musculoskeletal Health Questionnaire (MSK-HQ)
14 questions scored on a 0-4-point scale, summed up to a 0 to 56 points score, with higher score indicating better musculoskeletal health.
Measured: Baseline and 4 weeks
EuroQol 5 Dimensions (EQ5D-5L)
The EQ5D-5L covers five domains: mobility, self-care, activities of daily living, pain/discomfort, and anxiety/depression, scored on a 5-point scale from 0 (worst imaginable health) to 5 (best imaginable health). Responses can be transformed into an index ranging from -0.59 to 1, where -0.59 represents worst possible state and 1 represents perfect health. The EQ5D Visual Analogue Scale (VAS) is also included, which is a question asking about the respondent's self-rated health on a vertical 0 to 100 visual analog scale, with 100 being best health.
Measured: Baseline and 4 weeks
Institute of Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ)
Measure and value health-related productivity loss for both paid and unpaid work. The instrument is found to be suitable for measuring absenteeism from paid work and productivity loss related to unpaid labor. Nine questions related to paid work and three questions related to unpaid work.
Measured: Baseline and 4 weeks
Sickness absence days
Total number of absence days during 6 months of follow-up adjusted for percentage of work and percentage of sickness absence. Register data from the national health and welfare services
Measured: 6 months
Time to sustainable return to work
The time until full sustainable return to work, i.e. at least 4 weeks without relapse during 6 months of follow-up. Register data from the national health and welfare services
Measured: 6 months
Proportion who have returned to work
Proportion of people with sustainable return to work (at least 4 weeks) at 6 months. Register data from the national health and welfare services
Measured: 6 months
Probability of return to work
Probability of working (i.e. not receiving medical benefits) each month during 6 months of follow-up, measured as repeated events. Register data from the national health and welfare services
Measured: 6 months
Health care costs
Use of health care will be collected from public registries including Norwegian Patient Registry (NPR), Municipal Patient and User Registry (KPR) and Control and Payment of Health Refunds (KUHR).
Measured: 6 months
Sickness absence costs
Sickness absence costs will be calculated based on data from the NAV registry
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start1 Nov 2018
- Primary completion1 Jul 2020
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal Pain DisorderStudies 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
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Labour and Welfare Administration
- Responsible party
- Sponsor
- Investigators
- Margreth Grotle, Prof, Principal investigator, Oslo Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196634
- Sponsor's protocol ID
- NSD 861249
- Status last verified
- Aug 2022
- First submitted
- 27 Nov 2019
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rysstad T, Grotle M, Traeger AC, Aasdahl L, Vigdal ON, Aanesen F, Oiestad BE, Pripp AH, Wynne-Jones G, Dunn KM, Fors EA, Linton SJ, Tveter AT. Predicting prolonged work absence due to musculoskeletal disorders: development, validation, and clinical usefulness of prognostic prediction models. Int Arch Occup Environ Health. 2025 Jul;98(4-5):385-397. doi: 10.1007/s00420-025-02129-8. Epub 2025 Apr 8.
PubMed 40198330Killingmo RM, Tveter AT, Pripp AH, Tingulstad A, Maas E, Rysstad T, Grotle M. Modifiable prognostic factors of high societal costs among people on sick leave due to musculoskeletal disorders: findings from an occupational cohort study. BMJ Open. 2024 Mar 1;14(3):e080567. doi: 10.1136/bmjopen-2023-080567.
PubMed 38431296Munk Killingmo R, Tveter AT, Smastuen MC, Storheim K, Grotle M. Comparison of self-reported and public registered absenteeism among people on long-term sick leave due to musculoskeletal disorders: criterion validity of the iMTA Productivity Cost Questionnaire. Eur J Health Econ. 2021 Aug;22(6):865-872. doi: 10.1007/s10198-021-01294-0. Epub 2021 Jun 1.
PubMed 34061299Tveter AT, Oiestad BE, Rysstad TL, Aanesen F, Tingulstad A, Smastuen MC, Grotle M. Risk assessment for prolonged sickness absence due to musculoskeletal disorders: protocol for a prospective cohort study. BMC Musculoskelet Disord. 2020 May 25;21(1):326. doi: 10.1186/s12891-020-03354-7.
PubMed 32450820
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Assessment for Prolonged Sickness Absence Due to Musculoskeletal Conditions
- ClinicalTrials.gov ID
- NCT04196634
- Acronym / sponsor ID
- NSD 861249
- Conditions
- Musculoskeletal Pain Disorder
- Keywords
- Risk Assessment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Norwegian Labour and Welfare Administration
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- Sep 2023 (estimated)
- First posted
- 12 Dec 2019 (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.
Musculoskeletal (MSK) conditions are a leading cause of years lived with disability worldwide and for the last decade they have also been the most common cause of sickness absence and disability pension in Norway.
Although most sickness absence is short-termed, a small proportion of people with MSK conditions are on long-term sick leave, contributing to large cost due to disbursement of benefits, productivity loss and extensive use of health care. There is growing evidence that long-term sickness absence is harmful to mental and physical health, with a reduced probability of return to work (RtW) with prolonged sickness absence. Thus, focusing on early RtW in people on sick leave due to MSK conditions is important to reduce the burden on both the individual and the society. However, to provide interventions to reduce the duration of sickness absence to all people on sick leave would require enormous resources. By targeting those at risk of long-term sickness absence, resources may be used differently, e.g. more resource-saving. By using information on modifiable risk factors from simple risk assessment tools, health care providers and other stakeholders may facilitate RtW in a better way.
The overall purposes of this project are 1) to identify the most accurate screening tool to identify people at a high risk of prolonged sickness absence due to a MSK condition, and 2) to investigate severity of MSK health, health-related quality-of-life, health care consumption, and costs across different risk profiles in people on sick leave due to MSK conditions. We will use registered data on sickness absence from 1 year before to 1 year after inclusion in the study.
Detailed description
Main aims are:
- To compare the predictive ability of the STarT MSK tool and the ÖMPSQ-SF, and other established risk factors for long-term sickness absence (e.g. symptoms of depression and emotional distress, low motivation for returning to work, low self-efficacy, work expectancies) for identifying prolonged sickness absence at 6- and 12-months follow-up due to MSK conditions
- To develop a prognostic model to predict risk of prolonged sickness absence at 12-month follow-up in people with MSK conditions
- To assess predictors for high costs (productivity loss and health care use) at 6- and 12-months follow-up in people on sick leave due to MSK conditions
The study will also include additional methodological and descriptive aims.
Prior to the data collection we translated and culturally adapted the Keele STarT MSK and MSK-HQ following the Beaton guidelines.
The study is conducted within the Norwegian Welfare and Labor Administration (NAV) system in collaboration with OsloMet - Oslo Metropolitan University. Data on sickness absence from the NAV registry will be retrieved prospectively in the period from study inclusion to 12 months follow-up, and retrospectively 12 months prior to inclusion in the study.
Previous studies show that 30-40% of people with MSK conditions have not RtW after 3 to 12 months. In order to conduct analyses including 15- 20 predictor variables, we aim at including 500-600 people on sick leave due to MSK conditions. As the main outcomes are collected through registries, we do not expect any dropouts.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People on sick leave | – | Other: Risk assessmentPeople on sick leave due to musculoskeletal conditions for at least 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People on sick leave due to musculoskeletal pain conditions in Norway were invited to participate. Eligible participants had to log on to their personal sickness absence website at the Norwegian Welfare and Labor Administration to be able to see a link to the project.
Key inclusion criteria (1 listed)
- People older than 18 years on sick leave due to musculoskeletal pain for at least 4 weeks
Key exclusion criteria (2 listed)
- People on sick leave for other pain conditions or diseases
- People not able to read or write Norwegian or English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk assessmentPeople on sick leave due to musculoskeletal conditions will be screened for potential risk factors for prolonged sickness absence. No intervention will be given. | Other | People on sick leave |
Primary outcome
Sickness absence days
Time frame: 12 months
Total number of absence days during 12 months of follow-up adjusted for percentage of work and percentage of sickness absence. Register data from the national health and welfare services
Time to sustainable return to work
Time frame: 12 months
The time until full sustainable return to work, i.e. at least 4 weeks without relapse during 12 months of follow-up. Register data from the national health and welfare services
Probability of return to work
Time frame: 12 months
Probability of working (i.e. not receiving medical benefits) each month during 12 months of follow-up, measured as repeated events. Register data from the national health and welfare services
Proportion who have returned to work
Time frame: 12 months
Proportion of people with sustainable return to work (at least 4 weeks) at 12 months. Register data from the national health and welfare services
Health care costs
Time frame: 12 months
Use of health care will be collected from public registries including Norwegian Patient Registry (NPR), Municipal Patient and User Registry (KPR) and Control and Payment of Health Refunds (KUHR).
Sickness absence costs
Time frame: 12 months
Sickness absence costs will be calculated based on data from the NAV registry
9 secondary outcomes
Musculoskeletal Health Questionnaire (MSK-HQ)
Time frame: Baseline and 4 weeks
EuroQol 5 Dimensions (EQ5D-5L)
Time frame: Baseline and 4 weeks
Institute of Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ)
Time frame: Baseline and 4 weeks
Sickness absence days
Time frame: 6 months
Time to sustainable return to work
Time frame: 6 months
Proportion who have returned to work
Time frame: 6 months
Probability of return to work
Time frame: 6 months
Health care costs
Time frame: 6 months
Sickness absence costs
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Derived from this study: PubMed 40198330Rysstad T, Grotle M, Traeger AC, Aasdahl L, Vigdal ON, Aanesen F, Oiestad BE, Pripp AH, Wynne-Jones G, Dunn KM, Fors EA, Linton SJ, Tveter AT. Predicting prolonged work absence due to musculoskeletal disorders: development, validation, and clinical usefulness of prognostic prediction models. Int Arch Occup Environ Health. 2025 Jul;98(4-5):385-397. doi: 10.1007/s00420-025-02129-8. Epub 2025 Apr 8.
- Derived from this study: PubMed 38431296Killingmo RM, Tveter AT, Pripp AH, Tingulstad A, Maas E, Rysstad T, Grotle M. Modifiable prognostic factors of high societal costs among people on sick leave due to musculoskeletal disorders: findings from an occupational cohort study. BMJ Open. 2024 Mar 1;14(3):e080567. doi: 10.1136/bmjopen-2023-080567.
- Derived from this study: PubMed 34061299Munk Killingmo R, Tveter AT, Smastuen MC, Storheim K, Grotle M. Comparison of self-reported and public registered absenteeism among people on long-term sick leave due to musculoskeletal disorders: criterion validity of the iMTA Productivity Cost Questionnaire. Eur J Health Econ. 2021 Aug;22(6):865-872. doi: 10.1007/s10198-021-01294-0. Epub 2021 Jun 1.
- Derived from this study: PubMed 32450820Tveter AT, Oiestad BE, Rysstad TL, Aanesen F, Tingulstad A, Smastuen MC, Grotle M. Risk assessment for prolonged sickness absence due to musculoskeletal disorders: protocol for a prospective cohort study. BMC Musculoskelet Disord. 2020 May 25;21(1):326. doi: 10.1186/s12891-020-03354-7.
- Individual participant dataSharing planned: Undecided
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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.
Margreth Grotle, Prof principal investigator
Oslo Metropolitan University
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 Musculoskeletal Pain Disorder, run by Oslo Metropolitan University at 1 site in Norway.
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 1 inclusion and 2 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 17 Feb 2023. 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 Norway. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sickness absence days (time frame: 12 months). The study lists 6 primary outcomes in all. 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 NCT04196634, which also lists 4 linked publications.
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 17 Feb 2023.