Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Back on Track: Evaluation of an Occupational Reintegration Protocol for Employees With Musculoskeletal Disorders

26 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

140

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Pays-Bas
      • Utrecht, Pays-Bas
        • Recrutement
        • Arbo Unie

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

Employees on sick leave due to musculoskeletal complaints receiving return-to-work guidance by a major occupational health service in The Netherlands

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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
Autre: The computer-assisted reintegration protocol for musculoskeletal disorders
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.
Control: usual care
Employees on sick leave due to musculoskeletal complaints receiving return-to-work guidance according to usual care.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Time until full RTW
Délai: 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 full RTW for at least 28 days.
Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Time until partial return to work
Délai: 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.
Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
Full return to work
Délai: 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).
Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
Partial return to work
Délai: 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).
Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
Way of returning to work
Délai: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
The way a participant returned to work (at the own job/company, with our without adjustments).
Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
Current work ability
Délai: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
Measured with the first question of the Work Ability Index (Tuomi et al., 1998)
Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
Presenteeism
Délai: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
Presenteeism will be assessed using adapted items based on the iMTA Productivity Costs Questionnaire (iPCQ) (Bouwmans et al., 2015).
Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
Pain
Délai: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
The average pain score in the past week measured with a Numeric Rating Score (Hawker et al., 2011)
Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
Self-reported health
Délai: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
Measured on a Visual Analogue Scale of the EQ-5D-5L (Herdman et al., 2011)
Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
Health-related quality of life
Délai: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
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)
Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Amsterdam UMC, location VUmc

Collaborateurs

Arbo Unie

Les enquêteurs

  • Chaise d'étude: Han Anema, Amsterdam UMC, location VUmc

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

29 juillet 2025

Achèvement primaire (Estimé)

1 août 2028

Achèvement de l'étude (Estimé)

1 août 2028

Dates d'inscription aux études

Première soumission

21 août 2026

Première soumission répondant aux critères de contrôle qualité

26 août 2026

Première publication (Réel)

28 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2025.0374

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner