- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07793526
Back on Track: Evaluation of an Occupational Reintegration Protocol for Employees With Musculoskeletal Disorders
26 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Beräknad)
140
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Jantine Maarleveld
- Telefonnummer: +31625684599
- E-post: j.maarleveld@amsterdamumc.nl
Studieorter
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-
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Utrecht, Nederländerna
- Rekrytering
- Arbo Unie
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Sannolikhetsprov
Studera befolkning
Employees on sick leave due to musculoskeletal complaints receiving return-to-work guidance by a major occupational health service in The Netherlands
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time until full RTW
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time until partial return to work
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studiestol: Han Anema, Amsterdam UMC, location VUmc
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
29 juli 2025
Primärt slutförande (Beräknad)
1 augusti 2028
Avslutad studie (Beräknad)
1 augusti 2028
Studieregistreringsdatum
Först inskickad
21 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
26 augusti 2026
Första postat (Faktisk)
28 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2025.0374
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