Musculoskeletal Disorders (MSDs)NCT07793526
Back on Track: Evaluation of an Occupational Reintegration Protocol for Employees With Musculoskeletal Disorders
An observational study of Musculoskeletal Disorders (MSDs), run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Musculoskeletal Disorders (MSDs)
- What is being tested?
- The computer-assisted reintegration protocol for musculoskeletal disorders
- How many people
- 140 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 Jul 2025to 1 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Employees on sick leave due to musculoskeletal complaints receiving return-to-work guidance by a major occupational health service in The Netherlands
Who may be able to join
- Aged 18-65 years
- Self-reported musculoskeletal complaints as primary reason for sick leave
- High risk of long-term sick leave
Who cannot join
- Musculoskeletal complaints due to pregnancy
- Retirement within one year
- Sick leave duration of >18 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Musculoskeletal Disorders (MSDs)
- Being tested
- The computer-assisted reintegration protocol for musculoskeletal disorders
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The computer-assisted reintegration protocol for musculoskeletal disordersOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until full RTW
The number of days from start sick leave until full RTW for at least 28 days.
Measured: 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
The number of days from start sick leave until partly RTW.
Measured: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
Full return to work
Whether a participant fully returned to work for at least 28 days at the end of follow-up period (yes/no).
Measured: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
Partial return to work
Whether a participant partial returned to work at the end of follow-up period (yes/no).
Measured: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
Way of returning to work
The way a participant returned to work (at the own job/company, with our without adjustments).
Measured: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
Current work ability
Measured with the first question of the Work Ability Index (Tuomi et al., 1998)
Measured: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
Presenteeism
Presenteeism will be assessed using adapted items based on the iMTA Productivity Costs Questionnaire (iPCQ) (Bouwmans et al., 2015).
Measured: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
Pain
The average pain score in the past week measured with a Numeric Rating Score (Hawker et al., 2011)
Measured: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
Self-reported health
Measured on a Visual Analogue Scale of the EQ-5D-5L (Herdman et al., 2011)
Measured: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
Health-related quality of life
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)
Measured: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start29 Jul 2025
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal Disorders (MSDs)Studies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Arbo Unie
- Responsible party
- Principal investigator, Jantine Maarleveld, Amsterdam UMC, location VUmc
- Investigators
- Han Anema, Study chair, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793526
- Sponsor's protocol ID
- 2025.0374
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07793526
- Acronym / sponsor ID
- 2025.0374
- Conditions
- Musculoskeletal Disorders (MSDs)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Arbo Unie
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: the computer-assisted reintegration protocol for musculoskeletal disorders | – | Other: The computer-assisted reintegration protocol for musculoskeletal disordersEmployees on sick leave due to musculoskeletal complaints receiving return-to-work guidance according to the computer-assisted reintegration protocol |
| Control: usual care | – | –Employees on sick leave due to musculoskeletal complaints receiving return-to-work guidance according to usual care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Employees on sick leave due to musculoskeletal complaints receiving return-to-work guidance by a major occupational health service in The Netherlands
Key inclusion criteria (3 listed)
- Aged 18-65 years
- Self-reported musculoskeletal complaints as primary reason for sick leave
- High risk of long-term sick leave
Key exclusion criteria (3 listed)
- Musculoskeletal complaints due to pregnancy
- Retirement within one year
- Sick leave duration of >18 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The computer-assisted reintegration protocol for musculoskeletal disordersThe 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. | Other | Intervention: the computer-assisted reintegration protocol for musculoskeletal disorders |
Primary outcome
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.
9 secondary outcomes
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).
Full return to work
Time frame: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
Partial return to work
Time frame: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
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).
Current work ability
Time frame: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
Presenteeism
Time frame: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
Pain
Time frame: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
Self-reported health
Time frame: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Han Anema study chair
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Disorders (MSDs), run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jantine Maarleveld (+31625684599, j.maarleveld@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time until full RTW (time frame: Baseline (T0), after 3 months (T1), after 6 months (T2), after 9 months (T3), after 12 months (T4).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.