Risk Assessment for Prolonged Sickness Absence Due to Musculoskeletal Conditions

February 14, 2023 updated by: Oslo Metropolitan University

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.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

560

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Oslo, Norway, 0130
        • Oslo Metropolitan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
People on sick leave
People on sick leave due to musculoskeletal conditions for at least 4 weeks.
People on sick leave due to musculoskeletal conditions will be screened for potential risk factors for prolonged sickness absence. No intervention will be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
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
12 months
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
12 months
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
12 months
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).
12 months
Sickness absence costs
Time Frame: 12 months
Sickness absence costs will be calculated based on data from the NAV registry
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Musculoskeletal Health Questionnaire (MSK-HQ)
Time Frame: Baseline and 4 weeks
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.
Baseline and 4 weeks
EuroQol 5 Dimensions (EQ5D-5L)
Time Frame: Baseline and 4 weeks
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.
Baseline and 4 weeks
Institute of Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ)
Time Frame: Baseline and 4 weeks
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.
Baseline and 4 weeks
Sickness absence days
Time Frame: 6 months
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
6 months
Time to sustainable return to work
Time Frame: 6 months
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
6 months
Proportion who have returned to work
Time Frame: 6 months
Proportion of people with sustainable return to work (at least 4 weeks) at 6 months. Register data from the national health and welfare services
6 months
Probability of return to work
Time Frame: 6 months
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
6 months
Health care costs
Time Frame: 6 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).
6 months
Sickness absence costs
Time Frame: 6 months
Sickness absence costs will be calculated based on data from the NAV registry
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Keele STarT MSK Screening tool
Time Frame: Baseline and 4 weeks
The STarT MSK consists of 10 items and the scores are summarized to a 0-12 score, with risk groups being categorized as follow: 0-4= low risk; 5-8= medium risk; 9-12= high risk of developing long-term pain or disability.
Baseline and 4 weeks
Örebro Musculoskeletal Pain Screening Questionnaire short form (ÖMPSQ -sf)
Time Frame: Baseline and 4 weeks
ÖMPSQ-sf contains 10 questions that are summed up to 0 to 100 score, with higher score indicating higher risk developing work disability.
Baseline and 4 weeks
Work conflict
Time Frame: Baseline and 4 weeks
Single question on work conflict: "Did you experience conflict(s) with your employer before you got sick-listed?" (Yes/No)
Baseline and 4 weeks
Work satisfaction
Time Frame: Baseline and 4 weeks

Measured with a single question: "If you take into consideration your work routines, management, salary, promotion possibilities and work mates, how satisfied are you with your job?" Measured on a numeric rating scale, 0=Not satisfied at all, 10=Completely satisfied

Measured with a single question: "Do you want to return to the same work/position or do you wish you had another work/position?" Answered with: Same work/position / Another work/position.

Baseline and 4 weeks
Work ability
Time Frame: Baseline and 4 weeks
Measured with a single question from the Work Ability Index: "Assume that your work ability at its best has a value of 10 ponts. How many points would you give to your current work ability?" Measured on a numeric rating scale where 0 means that you cannot currently work at all, 10 means that your work ability is at its best right now.
Baseline and 4 weeks
Return to work expectancy
Time Frame: Baseline and 4 weeks
Measured with a single question: "For how long do you believe you will be sick listed from today?" Answered with: Not at all / Less than 1 month / 1-2 months / 2-4 months / 4-10 months / More than 10 months
Baseline and 4 weeks
Demographic variables
Time Frame: Baseline
Gender, age, diagnosis
Baseline
Change in condition
Time Frame: 4 weeks
7-point global rating of change: "Could you please state the amount of change concerning your musculoskeletal symptoms compared to when you first filled out this questionnaire". Answered with: Much better / Better / Slightly better / Unchanged / Slightly worse / Worse / Much worse
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Margreth Grotle, Prof, Oslo Metropolitan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

July 1, 2020

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

November 27, 2019

First Submitted That Met QC Criteria

December 11, 2019

First Posted (Actual)

December 12, 2019

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

August 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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