NCT07793526

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
24mo left

Started Jul 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress36%
Jul 2025Aug 2028

Study Start

First participant enrolled

July 29, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 28, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

3 years

First QC Date

August 21, 2026

Last Update Submit

August 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time until full RTW

    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).

Secondary Outcomes (9)

  • Time until partial return to work

    Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).

  • Full return to work

    Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).

  • Partial return to work

    Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).

  • Way of returning to work

    Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).

  • Current work ability

    Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).

  • +4 more secondary outcomes

Study Arms (2)

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

Other: The computer-assisted reintegration protocol for musculoskeletal disorders

Control: usual care

Employees on sick leave due to musculoskeletal complaints receiving return-to-work guidance according to usual care.

Interventions

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.

Intervention: the computer-assisted reintegration protocol for musculoskeletal disorders

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Aged 18-65 years
  • Self-reported musculoskeletal complaints as primary reason for sick leave
  • High risk of long-term sick leave

You may not qualify if:

  • Musculoskeletal complaints due to pregnancy
  • Retirement within one year
  • Sick leave duration of \>18 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arbo Unie

Utrecht, Netherlands

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

  • Han Anema

    Amsterdam UMC, location VUmc

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

August 21, 2026

First Posted

August 28, 2026

Study Start

July 29, 2025

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

August 28, 2026

Record last verified: 2026-08

Locations