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NCT Number: NCT07793526

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

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Key information

Conditions

Musculoskeletal Disorders (MSDs) Musculoskeletal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Arbo Unie

Utrecht, Netherlands

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The computer-assisted reintegration protocol for musculoskeletal disorders

Other

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.

Primary outcomes

  1. Time until full RTW

    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 full RTW for at least 28 days.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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).

    The way a participant returned to work (at the own job/company, with our without adjustments).

  5. Current work ability

    Time frame: 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)

  6. Presenteeism

    Time frame: 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).

  7. Pain

    Time frame: 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)

  8. Self-reported health

    Time frame: 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)

  9. 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).

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Jantine Maarleveld

CONTACT

[email protected]

+31625684599

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Collaborators

  • Arbo Unie

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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