An interventional study of SmaRTWork in Sick Leave and Musculoskeletal, sponsored by Norwegian University of Science and Technology. Not yet recruiting at 1 site in Norway. Open to participants aged 20 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Treatment
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.
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.
657 studies on the registry are indexed under Musculoskeletal Diseases; 159 are open to participants now.
This study's planned enrollment of 298 is above the median of 73 across 438 interventional studies indexed under Musculoskeletal Diseases.
Browse Musculoskeletal Diseases studies →Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Red flags that could indicate serious underlying pathology:
This group receives the SmaRTWork intervention in addition to usual care
Behavioral: SmaRTWork
The participants receive usual care as if they were not part of any study. There are no restrictions on what they can or cannot do.
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.
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
Time frame: 12 months from randomization
Number of sickness absence days
Total number of sickness absence days during 12 months of follow-up from randomization based on registry data
Time frame: 12 months from randomization
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
Time frame: 12 months from randomization
Musculoskeletal Health Questionnaire (MSK-HQ)
Questionnaire that measures musculoskeletal health with scores from 0 to 56 points, with higher scores indicating better musculoskeletal health
Time frame: From randomization to 12 months of follow-up
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)
Time frame: 12 months from randomization
Average pain last week
Measured by a numeric rating scale scores from 0 (no pain) to 10 (worst imaginable pain)
Time frame: 12 months from randomization
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
Time frame: 12 months from randomization
Depressive symptoms
Depressive symptoms by the Patient Health Questionnaire-2 (PHQ-2), scores range from 0-6 (higher more symptoms)
Time frame: 12 months from randomization
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)
Time frame: 12 months from randomization
Work ability
Work ability measured by the single item from the Work Ability Index (WAI) scored from 0 (worst) to 10 (best).
Time frame: 12 months from randomization
Overall improvement
Assessed by the Global Perceived Effect scale. Range, -5 to 5, with positive scores indicating improvement of pain
Time frame: 12 months from randomization
Fear avoidance beliefs
Measured by one-item from Tampa Scale of Kinesiophobia scored from 0 (no fear) to 10 (much fear)
Time frame: 12 months from randomization
Stress
Measured by the Perceived Stress Scale, scored from 0 to 40, with higher scores indicating greater perceived stress
Time frame: 12 months from randomization
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
Time frame: 12 months from randomization
Plan to share: No — Due to the ethical consent data cannot be shared.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Norwegian University of Science and Technology