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

NCT07034040 | Not Yet Recruiting

• 2 other identifiers: 563919315041
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 1

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.

Conditions

Sick Leave; Musculoskeletal

Keywords

Sick leave; musculoskeletal disorder; sickness absence; return to work; mHealth

Outcome Measures

Primary Outcomes (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

  12 months from randomization

Secondary Outcomes (11)

• Number of sickness absence days

  12 months from randomization

• Probability of working each month

  12 months from randomization

• Musculoskeletal Health Questionnaire (MSK-HQ)

  From randomization to 12 months of follow-up

• Health-related quality of life

  12 months from randomization

• Average pain last week

  12 months from randomization

Study Arms (2)

SmaRTWork

EXPERIMENTAL

This group receives the SmaRTWork intervention in addition to usual care

Behavioral: SmaRTWork

Usual care

NO INTERVENTION

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.

Interventions

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.

SmaRTWork

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, 7027, Norway

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

• Lene Aasdahl, MD PhD

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

• Solveig K Grudt, Head of Department

  Norwegian University of Science and Technology

  STUDY CHAIR

Central Study Contacts

Lene Aasdahl, MD PhD

CONTACT

+47 93224342; lene.aasdahl@ntnu.no

Paul J Mork, PhD

CONTACT

+47 90104615; paul.mork@ntnu.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)