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

NCT ID: NCT07034040

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 298 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2028-12-31

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.

Conditions

Sick Leave; Musculoskeletal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SmaRTWork

This group receives the SmaRTWork intervention in addition to usual care

Group Type: EXPERIMENTAL

SmaRTWork

Intervention Type: 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.

Usual care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SmaRTWork

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lene Aasdahl, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Solveig K Grudt, Head of Department

Role: STUDY_CHAIR

Norwegian University of Science and Technology

Locations

Norwegian University of Science and Technology

Trondheim, , Norway

Countries

Norway

Central Contacts

Lene Aasdahl, MD PhD

Role: CONTACT

lene.aasdahl@ntnu.no

+47 93224342

Paul J Mork, PhD

Role: CONTACT

paul.mork@ntnu.no

+47 90104615

Facility Contacts

Lene Aasdahl, MD PhD

Role: primary

lene.aasdahl@ntnu.no

93224342

Paul J Mork, PhD

Role: backup

paul.mork@ntnu.no

+47 90104615

Other Identifiers

315041

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

563919

Identifier Type: -

Identifier Source: org_study_id