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Sick LeaveSmaRTWorkNCT07034040

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

A study testing SmaRTWork in people with Sick Leave and Musculoskeletal, run by Norwegian University of Science and Technology at 1 site in Norway.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 59 years
Conditions the study is for
Sick Leave, Musculoskeletal
What is being tested?
SmaRTWork
Could I receive a placebo?
No, everyone receives an active treatment
How many people
298 participants
Where
1 siteNorway
Study dates
Nov 2026to Dec 2028
Phase
Interventional
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 20 to 59 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lene Aasdahl, MD PhD contact

+47 93224342

lene.aasdahl@ntnu.no

Paul J Mork, PhD contact

+47 90104615

paul.mork@ntnu.no

Norway1 site

  • Norwegian University of Science and Technology

    Trondheim, 7027

    Lene Aasdahl, MD PhD, 93224342, lene.aasdahl@ntnu.no

    Paul J Mork, PhD, +47 90104615, paul.mork@ntnu.no

Other trials in Norway

About this study

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.

Read the detailed description

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.

Being tested
SmaRTWork
Keywords
Sick leave, musculoskeletal disorder, sickness absence, return to work, mHealth
Medical subject headings
Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SmaRTWorkBehavioural

    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.

Study groups in NCT07034040
Study groupRoleWhat they receive
SmaRTWorkExperimentalThis group receives the SmaRTWork intervention in addition to usual care
Receives: Behavioral: SmaRTWork
Usual careNo interventionThe participants receive usual care as if they were not part of any study. There are no restrictions on what they can or cannot do.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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

    Measured: 12 months from randomization

Secondary outcomes (13)

  1. Number of sickness absence days

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

    Measured: 12 months from randomization

  2. Probability of working each month

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

    Measured: 12 months from randomization

  3. Musculoskeletal Health Questionnaire (MSK-HQ)

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

    Measured: From randomization to 12 months of follow-up

  4. Health-related quality of life

    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)

    Measured: 12 months from randomization

  5. Average pain last week

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

    Measured: 12 months from randomization

  6. Pain Self-Efficacy

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

    Measured: 12 months from randomization

  7. Depressive symptoms

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

    Measured: 12 months from randomization

  8. Brief Illness Perception

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

    Measured: 12 months from randomization

  9. Work ability

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

    Measured: 12 months from randomization

  10. Overall improvement

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

    Measured: 12 months from randomization

  11. Fear avoidance beliefs

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

    Measured: 12 months from randomization

  12. Stress

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

    Measured: 12 months from randomization

  13. Insomnia

    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

    Measured: 12 months from randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2025
  2. Study startNov 2026 (estimated)
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
298 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07034040
Sponsor's protocol ID
563919
Other IDs
315041
Acronym
SmaRTWork
Status last verified
Oct 2026
First submitted
13 Jun 2025
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to the ethical consent data cannot be shared.

Publications

  • Aasdahl L, Bach K, Nilsen TIL, Ottersen SG, Klevanger NE, Eder C, Overas CK, Granviken F, Debik J, Lervik LCN, Fossen H, Bones AF, Gismervik S, Hara KW, Mork PJ. Effectiveness of an artificial intelligence-based self-management intervention to support sick-listed individuals with musculoskeletal disorders in Norway: rationale and protocol for the SmaRTWork randomised controlled trial. BMJ Open. 2026 Aug 18;16(8):e122680. doi: 10.1136/bmjopen-2026-122680.

    PubMed 42613108

Questions about this trial

What is this clinical trial studying?

A study testing SmaRTWork in people with Sick Leave and Musculoskeletal, run by Norwegian University of Science and Technology at 1 site in Norway.

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 5 inclusion and 19 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: opening soon, as of the sponsor's last update on 15 Oct 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 Norway. 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 Lene Aasdahl, MD PhD (+47 93224342, lene.aasdahl@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to sustainable return-to-work (RTW) (time frame: 12 months from randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07034040, which also lists 1 linked publication.

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 15 Oct 2026.

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