Back on Track: Evaluation of an Occupational Reintegration Protocol for Employees With Musculoskeletal Disorders
26 agosto 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Stimato)
140
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Jantine Maarleveld
- Numero di telefono: +31625684599
- Email: j.maarleveld@amsterdamumc.nl
Luoghi di studio
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Utrecht, Olanda
- Reclutamento
- Arbo Unie
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Metodo di campionamento
Campione di probabilità
Popolazione di studio
Employees on sick leave due to musculoskeletal complaints receiving return-to-work guidance by a major occupational health service in The Netherlands
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Time until full RTW
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Time until partial return to work
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Han Anema, Amsterdam UMC, location VUmc
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
29 luglio 2025
Completamento primario (Stimato)
1 agosto 2028
Completamento dello studio (Stimato)
1 agosto 2028
Date di iscrizione allo studio
Primo inviato
21 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
26 agosto 2026
Primo Inserito (Effettivo)
28 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
28 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
26 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2025.0374
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .