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

Not Applicable

Not yet recruiting

• Conditions: Sick Leave; Musculoskeletal

• Registration Number: NCT07034040
• Lead Sponsor: Norwegian University of Science and Technology

Brief 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. 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.

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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-13
• Study First Submitted QC: 2025-06-13
• Last Update Submitted: 2025-06-13
• Study First Posted: 2025-06-24
• Last Update Posted: 2025-06-24
• Study Start: 2025-08-01
• Primary Completion: 2027-12
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 298

Inclusion Criteria

• Individuals 20-59 years old (working age)
• Living in Norway
• Sick-listed due to a musculoskeletal disorder for up to 12 weeks
• Musculoskeletal complaints are the main reason for sick leave.
• The main diagnosis for sick leave is unspecific 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

• Do not have a smartphone with internet access (i.e., to be able to download and access the SmaRTWork app).

• Pregnant

• No employer (unemployed or self-employed)

• Poor Norwegian comprehension

• Sick listed for more than 3 months the last year

• Have a planned date for RTW during the next week

• Have previously participated in the study or currently participating in other studies

• 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) that prevents participation

• Pain has not been assessed by a physician

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to sustainable return-to-work (RTW)	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 Outcome Measures

Name	Time	Method
Number of sickness absence days	12 months from randomization	Total number of sickness absence days during 12 months of follow-up from randomization based on registry data
Probability of working each month	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
Musculoskeletal Health Questionnaire (MSK-HQ)	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
Health-related quality of life	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)
Average pain last week	12 months from randomization	Measured by a numeric rating scale scores from 0 (no pain) to 10 (worst imaginable pain)
Overall improvement	12 months from randomization	Assessed by the Global Perceived Effect scale. Range, -5 to 5, with positive scores indicating improvement of pain
Fear avoidance beliefs	12 months from randomization	Measured by one-item from Tampa Scale of Kinesiophobia scored from 0 (no fear) to 10 (much fear)
Pain Self-Efficacy	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
Depressive symptoms	12 months from randomization	Depressive symptoms by the Patient Health Questionnaire-2 (PHQ-2), scores range from 0-6 (higher more symptoms)
Brief Illness Perception	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)
Work ability	12 months from randomization	Work ability measured by the single item from the Work Ability Index (WAI) scored from 0 (worst) to 10 (best).

Trial Locations

Locations (1)

Norwegian University of Science and Technology; 🇳🇴 Trondheim, Norway