NCT04196634

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
560

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 12, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

February 17, 2023

Status Verified

August 1, 2022

Enrollment Period

1.7 years

First QC Date

November 27, 2019

Last Update Submit

February 14, 2023

Conditions

Keywords

Risk Assessment

Outcome Measures

Primary Outcomes (6)

  • 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

    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

    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

    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

    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).

    12 months

  • Sickness absence costs

    Sickness absence costs will be calculated based on data from the NAV registry

    12 months

Secondary Outcomes (9)

  • Musculoskeletal Health Questionnaire (MSK-HQ)

    Baseline and 4 weeks

  • EuroQol 5 Dimensions (EQ5D-5L)

    Baseline and 4 weeks

  • Institute of Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ)

    Baseline and 4 weeks

  • Sickness absence days

    6 months

  • Time to sustainable return to work

    6 months

  • +4 more secondary outcomes

Other Outcomes (8)

  • Keele STarT MSK Screening tool

    Baseline and 4 weeks

  • Örebro Musculoskeletal Pain Screening Questionnaire short form (ÖMPSQ -sf)

    Baseline and 4 weeks

  • Work conflict

    Baseline and 4 weeks

  • +5 more other outcomes

Study Arms (1)

People on sick leave

People on sick leave due to musculoskeletal conditions for at least 4 weeks.

Other: Risk assessment

Interventions

People on sick leave due to musculoskeletal conditions will be screened for potential risk factors for prolonged sickness absence. No intervention will be given.

People on sick leave

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemale gender is a risk factor for developing musculoskeletal conditions, so we expect more women to be included in the study.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • People older than 18 years on sick leave due to musculoskeletal pain for at least 4 weeks

You may not qualify if:

  • People on sick leave for other pain conditions or diseases
  • People not able to read or write Norwegian or English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo Metropolitan University

Oslo, 0130, Norway

Location

Related Publications (3)

  • Killingmo 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.

  • Munk 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.

  • Tveter 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.

MeSH Terms

Conditions

Collagen Diseases

Interventions

Risk Assessment

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RiskProbabilityStatistics as TopicEpidemiologic MethodsInvestigative TechniquesRisk ManagementOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Margreth Grotle, Prof

    Oslo Metropolitan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2019

First Posted

December 12, 2019

Study Start

November 1, 2018

Primary Completion

July 1, 2020

Study Completion

September 1, 2023

Last Updated

February 17, 2023

Record last verified: 2022-08

Locations