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NCT Number: NCT07034040

SmaRTWork - a Decision Support System to Promote Return to Work Among People Sick-listed With Musculoskeletal Disorders

The objective of this study is to evaluate the effect of an intervention, SmaRTWork, on return to work compared to usual care for individuals who are sick-listed due to musculoskeletal disorders. Potential participants are individuals of working age (20-59 years) sick-listed due to a musculoskeletal disorder (neck pain, low back pain, or widespread pain) for up to 12 weeks living in Norway. The primary outcome will be time to sustainable return to work. We will also evaluate the effect on other work outcomes and health outcomes. We will also interview participants and stakeholders about their experience with the intervention.

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Key information

Age range

20 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The objective of this study is to determine the effectiveness of SmaRTWork (intervention) on return to work (RTW) compared to usual care (comparator) for individuals sick-listed due to musculoskeletal disorders. The study is designed as a single-blinded randomised controlled trial (RCT) with two parallel groups. Individuals of working age (20-59 years) sick-listed due to a musculoskeletal disorder (neck pain, low back pain, or widespread pain) for up to 12 weeks living in Norway are eligible for the study. Potential participants are identified and informed about the project by their general practitioner. We plan to include a total of 298 participants in the trial (and 15-20 in a pilot, giving a total of 318). The primary outcome will be time to sustainable RTW, i.e., one month without receiving sickness benefits, during the 12 months of follow-up based on registry data. Secondary outcomes include other work outcomes and health outcomes. Along with the RCT we will also conduct qualitative studies and a process evaluation. If the SmaRTWork turns out to be effective on RTW, we will also perform a health economic evaluation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Individuals 20-59 years old (working age)
  • Living in Norway
  • Own a smart phone with internet access
  • Sick-listed due to a musculoskeletal disorder for up to 12 weeks
  • The main diagnosis for sick leave is back pain, neck pain or widespread pain. For example one of the following (ICPC-2 diagnoses codes): Neck symptom/complaint (L01), Back symptom/complaint (L02), Low back symptom/complaint (L03), Muscle pain (L18), Back syndrome without radiating pain (L84)

Exclusion criteria

  • Pregnant
  • No employer (unemployed or self-employed)
  • Poor Norwegian comprehension
  • Sick listed for more than 3 months the previous 12 months
  • Have a planned date for RTW during the next week
  • previous participation in the trial or concurrent participation in another study that could interfere with the current trial
  • Unable to take part in exercise/physical activity (e.g., use of walking aids, unable to get up and down on the floor independently)
  • Leg pain worse than back pain
  • Red flags that could indicate serious underlying pathology:
  • Changes in bladder or bowel function
  • General feeling of being unwell (malaise), fever and/or unexplained weight loss
  • Reduced muscle (motor) function, sensory loss, walking problems or balance problems
  • Neck or back pain that started after the age of 55 or feel different from previous pain episodes
  • Pain that does not improve with rest or light activity or pain that is much worse during the night
  • Previous or ongoing cancer
  • Use of steroids/immune suppressing medications or drug use
  • Pain that is trauma (injury) related
  • Serious ongoing somatic (e.g., unstable heart disease) or mental disorder (e.g., psychosis, ongoing manic episode, suicidal ideation)
  • Pain has not been assessed by a clinician

Treatment and study plan

SmaRTWork

Behavioral

The SmaRTWork app provides weekly individually tailored self-management plans by matching the participant's health information and sick leave status with targeted educational messages, physical activity advice, and exercise recommendations. In addition, participants with specific problems regarding i) work accommodations, ii) workplace conflicts, iii) large responsibilities as caregivers, iv) financial problems, or v) who do not think they will return to the old workplace are offered to be set in contact with a caseworker at the social insurance office. The intervention is given in addition to usual care.

Primary outcomes

  1. Time to sustainable return-to-work (RTW)

    Time frame: 12 months from randomization

    Time to sustainable return-to-work (RTW), i.e., one month without receiving sickness benefits, during the 12 months of follow-up from randomization based on registry data

Secondary outcomes

  1. Number of sickness absence days

    Time frame: 12 months from randomization

    Total number of sickness absence days during 12 months of follow-up from randomization based on registry data

  2. Probability of working each month

    Time frame: 12 months from randomization

    The probability of working (i.e., not receiving medical benefits) each month during 12 months of follow-up, measured as repeated events

  3. Musculoskeletal Health Questionnaire (MSK-HQ)

    Time frame: From randomization to 12 months of follow-up

    Questionnaire that measures musculoskeletal health with scores from 0 to 56 points, with higher scores indicating better musculoskeletal health

  4. Health-related quality of life

    Time frame: 12 months from randomization

    Assessed by the EuroQol 5-dimension questionnaire, weighted according to the Danish value set (range, 0-1, with higher scores indicating better health status) and the EuroQol visual analog scale (range, 0-100, with higher scores indicating better health status)

  5. Average pain last week

    Time frame: 12 months from randomization

    Measured by a numeric rating scale scores from 0 (no pain) to 10 (worst imaginable pain)

  6. Pain Self-Efficacy

    Time frame: 12 months from randomization

    Ability to cope despite pain as assessed with the Pain Self-Efficacy Questionnaire (PSEQ), range, 0-60, with higher scores indicating greater confidence

  7. Depressive symptoms

    Time frame: 12 months from randomization

    Depressive symptoms by the Patient Health Questionnaire-2 (PHQ-2), scores range from 0-6 (higher more symptoms)

  8. Brief Illness Perception

    Time frame: 12 months from randomization

    Cognitive and emotional perceptions of illness assessed by the Brief Illness Perception Questionnaire (range, 0-80, with higher scores indicating greater illness perception)

  9. Work ability

    Time frame: 12 months from randomization

    Work ability measured by the single item from the Work Ability Index (WAI) scored from 0 (worst) to 10 (best).

  10. Overall improvement

    Time frame: 12 months from randomization

    Assessed by the Global Perceived Effect scale. Range, -5 to 5, with positive scores indicating improvement of pain

  11. Fear avoidance beliefs

    Time frame: 12 months from randomization

    Measured by one-item from Tampa Scale of Kinesiophobia scored from 0 (no fear) to 10 (much fear)

  12. Stress

    Time frame: 12 months from randomization

    Measured by the Perceived Stress Scale, scored from 0 to 40, with higher scores indicating greater perceived stress

  13. Insomnia

    Time frame: 12 months from randomization

    Measured by items from the The Trøndelag Health Study (HUNT) populations study. Higher scores worse. Items can be combined to approximate classification of insomnia diagnosis

Study contacts

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

Lene Aasdahl, MD PhD

CONTACT

[email protected]

+47 93224342

Paul J Mork, PhD

CONTACT

[email protected]

+47 90104615

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Acronym: SmaRTWork

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 24, 2025
Registry last updated
Jul 13, 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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