- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07793526
Back on Track: Evaluation of an Occupational Reintegration Protocol for Employees With Musculoskeletal Disorders
August 26, 2026 updated by: Jantine Maarleveld, Amsterdam UMC, location VUmc
Back on Track: Evaluation of a Computer-Assisted Occupational Reintegration Protocol for Sick-listed Employees With High Risk for Long-Term Sick Leave Due to Musculoskeletal Disorders
The objective of the Back on Track study is to evaluate a computer-assisted reintegration protocol for musculoskeletal disorders of a major occupational health service in the Netherlands on its (cost-)effectiveness and conduct a process evaluation.
The computer-assisted reintegration protocol aims to reduce sick leave duration and sick-leave associated costs, with the intention to mitigate the impact of sick leave for both employee and employer.
Furthermore, this study might provide valuable insights for the improvement of reintegration guidance for workers with musculoskeletal disorders in general.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The objective of the Back on Track study is to evaluate a computer-assisted reintegration protocol for musculoskeletal disorders of a major occupational health service in the Netherlands on its (cost-)effectiveness and conduct a process evaluation.
This protocol is characterized by an evidence-based, early, intensive and multidisciplinary approach.
A non-randomized controlled study will compare employees on sick leave due to musculoskeletal complaints who are at high risk of long-term sick leave and receive care based on the computer-assisted reintegration protocol (n = 70) with employees receiving usual care (n = 70).
The primary outcome will be time until full return to work.
Secondary outcomes will include time until partial return to work , full and partial return to work (yes/no), way of return to work (at the own job/company, with our without adjustments), work ability, work productivity, pain, self-reported health and health-related quality of life.
Participants will be asked to complete questionnaires at baseline and after three, six, nine and 12 months.
Furthermore, data will be obtained from the occupational health service's register.
Alongside the effectiveness study, economic and process evaluations will be conducted.
Study Type
Observational
Enrollment (Estimated)
140
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jantine Maarleveld
- Phone Number: +31625684599
- Email: j.maarleveld@amsterdamumc.nl
Study Locations
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Utrecht, Netherlands
- Recruiting
- Arbo Unie
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Employees on sick leave due to musculoskeletal complaints receiving return-to-work guidance by a major occupational health service in The Netherlands
Description
Inclusion Criteria:
- Aged 18-65 years
- Self-reported musculoskeletal complaints as primary reason for sick leave
- High risk of long-term sick leave
Exclusion Criteria:
- Musculoskeletal complaints due to pregnancy
- Retirement within one year
- Sick leave duration of >18 days
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 |
|---|---|
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Intervention: the computer-assisted reintegration protocol for musculoskeletal disorders
Employees on sick leave due to musculoskeletal complaints receiving return-to-work guidance according to the computer-assisted reintegration protocol
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The computer-assisted reintegration protocol for musculoskeletal disorders provides an operationalization of the NVAB-guidelines of 'Low Back Pain and Radicular Syndrome' (Luites et al., 2020) and 'Complaints of Arm, Neck and Shoulder' (Elders et al., 2014) and the Dutch Gatekeeper Act.
It is designed for occupational health professionals that are involved in the reintegration process of employees on high risk for long term sick leave due to musculoskeletal disorders.
It starts from the third week of sick leave until the employee has returned, for a maximum of two years.
The central themes of the protocol are an evidence-based, early, intensive and a multidisciplinary approach.
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Control: usual care
Employees on sick leave due to musculoskeletal complaints receiving return-to-work guidance according to usual care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time until full RTW
Time Frame: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
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The number of days from start sick leave until full RTW for at least 28 days.
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Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time until partial return to work
Time Frame: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
|
The number of days from start sick leave until partly RTW.
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Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
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Full return to work
Time Frame: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
|
Whether a participant fully returned to work for at least 28 days at the end of follow-up period (yes/no).
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Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
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Partial return to work
Time Frame: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
|
Whether a participant partial returned to work at the end of follow-up period (yes/no).
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Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
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Way of returning to work
Time Frame: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
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The way a participant returned to work (at the own job/company, with our without adjustments).
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Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
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Current work ability
Time Frame: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
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Measured with the first question of the Work Ability Index (Tuomi et al., 1998)
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Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
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Presenteeism
Time Frame: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
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Presenteeism will be assessed using adapted items based on the iMTA Productivity Costs Questionnaire (iPCQ) (Bouwmans et al., 2015).
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Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
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Pain
Time Frame: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
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The average pain score in the past week measured with a Numeric Rating Score (Hawker et al., 2011)
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Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
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Self-reported health
Time Frame: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
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Measured on a Visual Analogue Scale of the EQ-5D-5L (Herdman et al., 2011)
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Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
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Health-related quality of life
Time Frame: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
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A combination of five domains (mobility, self-care, daily activities, pain/discomfort and anxiety/gloom) measured with the EQ-5D-5L (Herdman et al., 2011)
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Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Han Anema, Amsterdam UMC, location VUmc
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)
July 29, 2025
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
August 1, 2028
Study Registration Dates
First Submitted
August 21, 2026
First Submitted That Met QC Criteria
August 26, 2026
First Posted (Actual)
August 28, 2026
Study Record Updates
Last Update Posted (Actual)
August 28, 2026
Last Update Submitted That Met QC Criteria
August 26, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025.0374
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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