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- Klinische proef NCT07793526
Back on Track: Evaluation of an Occupational Reintegration Protocol for Employees With Musculoskeletal Disorders
26 augustus 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Geschat)
140
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Jantine Maarleveld
- Telefoonnummer: +31625684599
- E-mail: j.maarleveld@amsterdamumc.nl
Studie Locaties
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Utrecht, Nederland
- Werving
- Arbo Unie
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
Employees on sick leave due to musculoskeletal complaints receiving return-to-work guidance by a major occupational health service in The Netherlands
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Time until full RTW
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Time until partial return to work
Tijdsspanne: 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 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
Tijdsspanne: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
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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
Tijdsspanne: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
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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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Han Anema, Amsterdam UMC, location VUmc
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
29 juli 2025
Primaire voltooiing (Geschat)
1 augustus 2028
Studie voltooiing (Geschat)
1 augustus 2028
Studieregistratiedata
Eerst ingediend
21 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
26 augustus 2026
Eerst geplaatst (Werkelijk)
28 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
28 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
26 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2025.0374
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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