Musculoskeletal, Sick Leave
Conditions
Keywords
Sick leave, musculoskeletal disorder, sickness absence, return to work, mHealth
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.
Interventions
BEHAVIORALSmaRTWork
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.
Sponsors
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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). |
| 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) |
| Stress | 12 months from randomization | Measured by the Perceived Stress Scale, scored from 0 to 40, with higher scores indicating greater perceived stress |
| Insomnia | 12 months from randomization | 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 |
Countries
Norway
Contacts
CONTACTLene Aasdahl, MD PhD
CONTACTPaul J Mork, PhD
PRINCIPAL_INVESTIGATORLene Aasdahl, MD PhD
Norwegian University of Science and Technology
STUDY_CHAIRSolveig K Grudt, Head of Department
Norwegian University of Science and Technology
Outcome results
None listed