Musculoskeletal DiseaseMI-NAVNCT03871712
Effectiveness of Motivational Interviewing on Return to Work in People on Sick Leave Due to Musculoskeletal Disorders
A study testing Motivational interview and Stratified vocational advice in people with Musculoskeletal Disease and Musculoskeletal Pain, run by Oslo Metropolitan University at 1 site in Norway.
Trial summary
Musculoskeletal disorders are the main causes for sickness absence and disability benefits in Norway and the leading causes of disability worldwide. There is strong evidence that long-term sickness absence due to musculoskeletal disorders provides a poor prognosis, both in terms of work-related disability, physical… Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Musculoskeletal Disease, Musculoskeletal Pain
- What is being tested?
- Motivational interview and Stratified vocational advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteNorway
- Study dates
- 1 Apr 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have musculoskeletal disorders
- Live in South-East Norway
- Have been on sick leave for 8 weeks with a current sick-leave status of 50%-100%
- Have a job to return to
Who cannot join
- Have serious somatic or psychological disorders (e.g. cancer, psychotic disorders)
- Have specific disorder requiring specialized, ongoing treatment;
- Are pregnant
- Are self-employed or work free lance
- Have insufficient Norwegian or English speaking or writing skills to participate in group session and fill out questionnaire.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Return to Work for People With Musculoskeletal Disorders: A Randomized Controlled Trial of the Effectiveness of Usual Case Management Compared to Usual Case Management Plus Motivational Interviewing or Stratified Vocational Advice Intervention. The MI-NAV Study
Musculoskeletal disorders are the main causes for sickness absence and disability benefits in Norway and the leading causes of disability worldwide. There is strong evidence that long-term sickness absence due to musculoskeletal disorders provides a poor prognosis, both in terms of work-related disability, physical and mental health, and health related quality-of-life. To assist people return to work a range of vocational rehabilitation programs exist, but the initiatives have not been able to reduce the number of people who are on sick leave due to musculoskeletal disorders. In Norway, The Norwegian Labour and Welfare Administration (NAV) case-workers have taken such approaches in use, primarily by teaching their employees with user contact in how to use Motivational Interviewing (MI). However, the evidence on the effectiveness of MI on return to work is highly uncertain. The objectives of this project are to compare the effectiveness and cost-effectiveness of usual case management alone with usual case management plus MI or usual case management plus stratified vocational advice intervention (SVAI), on RTW among people on sick leave due to musculoskeletal (MSK) disorders. All musculoskeletal diagnoses will be included. A multi-arm randomised controlled trial with 150 participants in each group will be conducted within the NAV system in Norway to evaluate these research questions.
Read the detailed description
The main objective of this project is to evaluate the effectiveness of usual case management plus motivational interviewing (MI), provided by trained Norwegian Labour and Welfare Administration (NAV) case-workers, and usual case management plus a Stratified Vocational Advice Intervention (SVAI), including principles of MI and vocational advice provided by trained physiotherapists, compared to usual case management alone on return to work among people on sick leave due to a musculoskeletal disorder. A multi-arm randomised controlled trial (RCT) will be conducted in order to respond to the following specific research questions:
RQ 1a Is there a difference between usual case management plus MI and usual case management alone in reducing sickness absence days at 6 months follow-up among individuals who have been on sick leave for >7 weeks due to a musculoskeletal disorder?
RQ 1b Is there a difference between usual case management plus SVAI and usual case management alone in reducing sickness absence days at 6 months follow-up among individuals who have been on sick leave for >7 weeks due to a musculoskeletal disorder?
RQ 2a Is there a difference between usual case management plus MI and usual case management alone in reducing sickness absence days at 12 months follow-up among individuals who have been on sick leave for >7 weeks due to a musculoskeletal disorder?
RQ 2b Is there a difference between usual case management plus SVAI and usual case management alone in reducing sickness absence days at 12 months follow-up among individuals who have been on sick leave for >7 weeks due to a musculoskeletal disorder?
RQ 3a Is there a difference between usual case management plus MI and usual case management alone in time until sustained RTW during 12 months follow-up among individuals who have been on sick leave for >7 weeks due to a musculoskeletal disorder?
RQ 3b Is there a difference between usual case management plus SVAI and usual case management alone in time until sustained RTW during 12 months of follow-up among individuals who have been on sick leave for >7 weeks due to a musculoskeletal disorder?
RQ 4a Is there a difference in the proportions of participants who receive sick leave benefits each month during 12 months of follow-up between usual case management plus MI compared to usual case management alone?
RQ 4b Is there a difference in the proportion of individuals who receive sick leave benefits each month during 12 months of follow-up between usual case management plus SVAI compared to usual case management alone?
RQ 5a Is there a difference in cost-effectiveness, cost-utility and cost-benefit during 6 months of follow-up between individuals on sick leave with musculoskeletal disorders who receive usual case management plus MI compared to those who receive usual case management alone?
RQ 5b Is there a difference in cost-effectiveness, cost-utility and cost-benefit during 6 months of follow-up between individuals on sick leave with musculoskeletal disorders who receive usual case management plus SVAI compared to those who receive usual case management alone?
RQ 6a Is there a difference in cost-effectiveness, cost-utility and cost-benefit during 12 months of follow-up between individuals on sick leave with musculoskeletal disorders who receive usual case management plus MI compared to those who receive usual case management alone?
RQ 6b Is there a difference in cost-effectiveness, cost-utility and cost-benefit during 12 months of follow-up between individuals on sick leave with musculoskeletal disorders who receive usual case management plus SVAI compared to those who receive usual case management alone?
RQ 7a Is there a difference in musculoskeletal health during 12 months of follow up between individuals on sick leave with musculoskeletal disorders who receive usual case management plus MI compared to those who receive usual case management alone?
RQ 7b Is there a difference in musculoskeletal health during 12 months of follow up between individuals on sick leave with musculoskeletal disorders who receive usual case management plus SVAI compared to those who receive usual case management alone?
The following hypotheses will be tested:
H 1a There is no difference in number of sickness absence days between participants who receive usual case management plus MI compared to those who receive usual case management alone at 6 months follow-up.
H 1b There is no difference in number of sickness absence days between participants who receive usual case management plus SVAI compared to those who receive usual case management alone at 6 months follow-up.
H 2a There is no difference in number of sickness absence days between participants who receive usual case management plus MI compared to those who receive usual case management alone at 12 months follow-up.
H 2b There is no difference in number of sickness absence days between participants who receive usual case management plus SVAI compared to those who receive usual case management alone at 12 months follow-up.
H 3a There is no difference in time until first sustained RTW between participants who receive usual case management plus MI compared to those who receive usual case management alone during 12 months follow-up.
H 3b There is no difference in time until first sustained RTW between participants who receive usual case management plus SVAI compared to those who receive usual case management alone during 12 months of follow-up.
H 4a There is no difference in the proportions of participants who receive sick leave benefits each month between usual case management plus MI compared to usual case management alone during 12 months of follow-up.
H 4b There is no difference in the proportions of individuals receiving sick leave benefits each month between usual case management plus SVAI compared to usual case management alone during 12 months of follow-up.
H 5a There is no difference in cost-effectiveness, cost-utility and cost-benefit between usual case management plus MI compared to usual case management alone during 6 months of follow up.
H 5b There is no difference in cost-effectiveness, cost-utility and cost-benefit between usual case management plus SVAI compared to usual case management alone during 6 months of follow up.
H 6a There is no difference in cost-effectiveness, cost-utility and cost-benefit between usual case management plus MI compared to usual case management alone during 12 months of follow up.
H 6b There is no difference in cost-effectiveness, cost-utility and cost-benefit between usual case management plus SVAI compared to usual case management alone during 12 months of follow up.
H 7a There is no difference in musculoskeletal health between participants who receive usual case management plus MI compared to those who receive usual case management alone during 12 months of follow-up.
H 7b There is no difference in musculoskeletal health between participants who receive usual case management plus SVAI compared to those who receive usual case management alone during 12 months of follow-up.
A multi-arm RCT with a full-scale health economic evaluation and mediator analysis will be conducted. In order to avoid contextual contamination effect only NAV offices in which the employees have not received any previous MI training will be included. All eligible participants will be asked to participate.
The head NAV office in Oslo will provide weely lists of persons meeting the eligibility criteria. We will contact eligible people by phone and give information about the study. Elibible persons who are interested will then receive a link to the informed consent and the baseline questionnaire.
MI intervention: In addition to usual case management, the MI group will receive 2 motivational interviews provided by a NAV case-worker. The case-workers will be educated and mentored throughout the study period. The first MI will be face-to-face, while the second may by phone, but preferable face-to-face.The interviews will be given in week 8/9 of the sick leave period, and then again after approximately 2 weeks.
SVAI intervention: In addition to usual case management, the SVAI group will be followed up by trained physical therapists. This group will be stratified into risk groups for long term sick leave; an "at risk group" and a "high risk group". The at risk group will receive 1-2 phone calls with emphasis on identifying obstacles for return to work, and solutions for resolving these obstacles. The high risk group will be followed up 3-4 times. The first follow-up is by phone, the remaining follow-ups can be either by phone or face to face meetings and can include a workplace visit. The SVAI intervention will end before week 26 of the participants' sick leave period.
Usual case management: The Norwegian welfare state has a system for following up people on sick leave, including a follow-up plan developed by the worker and the employer by week 4 of the sick leave period, a dialogue meeting between the worker and the employer by week 7, and a second dialogue Meeting including a NAV caseworker, by week 26.
The study flow:
Baseline recruitment will occur by week 8 of the sick leave period. The two interventions will start immediately after randomization and baseline assessments. The questionnaires will be sent electronic through a secure system from University of Oslo at baseline, and after 3, 6, 9, and 12 months.
A pilot study will be conducted prior to start of the RCT to test the study protocol including the recruitment procedure, the randomisation procedure, the information flow between researchers, physical therapists, NAV case workers and study participants, and the interventions (MI and SVAI). The pilot study will end by the first 100 included participants (August 31. 2019). The participants in the pilot study will be included in the RCT as long as the protocol will not be changed with respect to the scientific method and research questions (internal pilot study).
A fidelity study of the MI and SVAI interventions will be conducted to measure how well the trained personnel is using the methods and interventions as intended. For the MI arm, a developed instrument (Motivational Interviewing Treatment Integrity Coding Manual 4.2.1) will be used to score the feasibility from audio recordings of all NAV case-workers who do the MI intervention. For the SVAI intervention, feasibility will be measured by both audiotaping and from the telephone script/journal that the SVAI physiotherapists fill out during the talk with the study participant. The investigators plan to do 20-25 audiotapes of the 5 SVAI physiotherapists.
- Conditions
- Musculoskeletal Disease, Musculoskeletal Pain
- Being tested
- Motivational interview, Stratified vocational advice
- Medical subject headings
- Musculoskeletal Diseases, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewBehavioural
The participants will be called twice with 2-4 weeks interval after the randomisation. This will be after 8 weeks of sick leave.
Stratified vocational adviceBehavioural
Also called Vocational advice
The participants will be called after the randomisation. The amount of calls/meetings will be decided after each call, but with a maximum of 4 for the high risk group. This may include physical meetings.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interview (MI) | Experimental | In the MI arm, a NAV case worker will meet the participants after the baseline assessment (electronic questionnaires) and randomisation and conduct the MI. The NAV case-worker will either meet (or call) again after a few weeks (anticipated 2-4 weeks) and conduct another MI. Receives: Behavioral: Motivational interview |
| Stratified vocational advice intervention (SVAI) | Active comparator | A trained physiotherapist will call the participants after the baseline assessment and randomisation. The SVAI intervention will be stratified due to the participants risk of long term sick leave estimated by the Orebro Screening Questionnaire and The Keele STarT MSK Tool. The low/moderate risk group will receive 1-2 phone calls, and the high risk group will be followed up 2-4 times. The follow-up can include face to face Meetings bewteen the Physical therapist and the participant, and also the employer and general practitioner when needed. The intervention will include an assessment of the participants obstacles for returning to work and help to develop and implement an action plan to overcome obstacles. The physical therapists' will cooperate with other health care providers and employer when needed. Receives: Behavioral: Stratified vocational advice |
| Usual follow-up | No intervention | This arm will be the control group receiving usual NAV follow-up. The other two groups will also receive usual NAV follow-up additionally to the interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sickness absence days
Total number of sickness absence days up to the 6-month's follow-up
Measured: 6 months
Secondary outcomes (8)
Sickness absence days
Total number of sickness absence days up to the 12-month's follow-up
Measured: 12 months
Sustainable return to work
Time in months until full sustainable return to work during 12 months of follow-up, defined as 4 weeks of 100% return to original employment fraction without relapse, obtained from national registers.
Measured: 12 months
Medical benefits
The chance of receiving medical benefits during 12 months of follow-up measured as repeated events assessed with data from national registers.
Measured: 12 months
Cost-utility
Cost-utility at 6 months assessed by healthcare utilisation obtained from national registries. To measure treatment effects and health utilities the Euro Quality of Life 5 Dimentions 5 Levels (EQ-5D-5L) utility index will be used. The EQ-5D-5L is a generic and preference-weighted measure of health-related quality-of-life based on five dimensions: mobility, self-care, activities of daily life, pain, and anxiety and/or depression. For each dimension, the patient assesses five possible levels of problems (from no to severe, 1-5). Health gains will be expressed as quality-adjusted life years (QALYs), which will be derived from the EQ-5D-5L utility scores, using the UK tariff. QALYs range from -0.59 to 1, where 1 corresponds to perfect health, and -0.59 to worst imaginable health.
Measured: 6 months
Cost-utility
Cost-utility at 12 months assessed by healthcare utilisation obtained from national registries. To measure treatment effects and health utilities the Euro Quality of Life 5 Dimentions 5 Levels (EQ-5D-5L) utility index will be used. The EQ-5D-5L is a generic and preference-weighted measure of health-related quality-of-life based on five dimensions: mobility, self-care, activities of daily life, pain, and anxiety and/or depression. For each dimension, the patient assesses five possible levels of problems (from no to severe, 1-5). Health gains will be expressed as quality-adjusted life years (QALYs), which will be derived from the EQ-5D-5L utility scores, using the UK tariff. QALYs range from -0.59 to 1, where 1 corresponds to perfect health, and -0.59 to worst imaginable health.
Measured: 12 months
Cost-effectiveness
Cost-effectiveness at 6 months assessed by healthcare utilisation obtained from national registries.
Measured: 6 months
Cost-effectiveness
Cost-effectiveness at 12 months assessed by healthcare utilisation obtained from national registries.
Measured: 12 months
Musculoskeletal health
Musculoskeletal health will be assessed at the 12 month's follow-up with the Musculoskeletal Health Questionnaire (MSK-HQ). MSK-HQ is a new outcome questionnaire with 14 items capturing a broad variety of musculoskeletal conditions. The score provides a range from 0 to 56, with higher scores indicating better MSK health status.The MSK-HQ has undergone initial psychometric testing in four different musculoskeletal cohorts and demonstrated high completion rates, excellent test-retest reliability and strong convergent validity with other disease-specific outcomes.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Apr 2019
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multi-arm randomised controlled trial with two intervention groups and one control group doing as usual (ordinary NAV practice). The allocation will be prepared with block randomisation for risk of long term sick leave as predicted by the Orebro Screening Questionnaire and The Keele STarT MSK Tool. Preliminary data suggests a low/medium risk group (80% of the recruited participants) and a high risk group (20%). These numbers were calculated in another study of individuals on sick leave in Norway.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Labour and Welfare Administration
- Responsible party
- Principal investigator, Britt Elin Øiestad, Oslo Metropolitan University
- Investigators
- Hege Bentzen, PhD, Study director, OsloMet - Oslo Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871712
- Sponsor's protocol ID
- The MI-NAV Study
- Acronym
- MI-NAV
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2019
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Killingmo RM, Rysstad T, Maas E, Pripp AH, Aanesen F, Tingulstad A, Tveter AT, Oiestad BE, Grotle M. Modifiable prognostic factors of high societal costs among people on sick leave due to musculoskeletal disorders: a replication study. BMC Musculoskelet Disord. 2024 Dec 3;25(1):990. doi: 10.1186/s12891-024-08132-3.
PubMed 39627785Venter M, Grotle M, Oiestad BE, Aanesen F, Tingulstad A, Rysstad T, Ferraro MC, McAuley JH, Cashin AG. Treatment Effect Modifiers for Return-to-Work in Patients With Musculoskeletal Disorders. J Pain. 2024 Sep;25(9):104556. doi: 10.1016/j.jpain.2024.104556. Epub 2024 May 6.
PubMed 38710259Tingulstad A, Maas ET, Rysstad T, Oiestad BE, Aanesen F, Pripp AH, Van Tulder MW, Grotle M. Six-month cost-effectiveness of adding motivational interviewing or a stratified vocational advice intervention to usual case management for workers with musculoskeletal disorders: the MI-NAV economic evaluation. J Occup Med Toxicol. 2023 Nov 14;18(1):25. doi: 10.1186/s12995-023-00394-2.
PubMed 37964240Cashin AG, Oiestad BE, Aanesen F, Storheim K, Tingulstad A, Rysstad TL, Lee H, McAuley JH, Sowden G, Wynne-Jones G, Tveter AT, Grotle M. Mechanisms of vocational interventions for return to work from musculoskeletal conditions: a mediation analysis of the MI-NAV trial. Occup Environ Med. 2023 May;80(5):246-253. doi: 10.1136/oemed-2022-108716. Epub 2023 Mar 2.
PubMed 36863864Aanesen F, Grotle M, Rysstad TL, Tveter AT, Tingulstad A, Lochting I, Smastuen MC, van Tulder MW, Berg R, Foster NE, Wynne-Jones G, Sowden G, Fors E, Bagoien G, Hagen R, Storheim K, Oiestad BE. Effectiveness of adding motivational interviewing or a stratified vocational advice intervention to usual case management on return to work for people with musculoskeletal disorders: the MI-NAV randomised controlled trial. Occup Environ Med. 2023 Jan;80(1):42-50. doi: 10.1136/oemed-2022-108637. Epub 2022 Nov 25.
PubMed 36428098Oiestad BE, Aanesen F, Lochting I, Storheim K, Tingulstad A, Rysstad TL, Smastuen MC, Tveter AT, Sowden G, Wynne-Jones G, Fors EA, van Tulder M, Berg RC, Foster NE, Grotle M. Study protocol for a randomized controlled trial of the effectiveness of adding motivational interviewing or stratified vocational advice intervention to usual case management on return to work for people with musculoskeletal disorders. The MI-NAV study. BMC Musculoskelet Disord. 2020 Jul 28;21(1):496. doi: 10.1186/s12891-020-03475-z.
PubMed 32723318
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Return to Work for People With Musculoskeletal Disorders: A Randomized Controlled Trial of the Effectiveness of Usual Case Management Compared to Usual Case Management Plus Motivational Interviewing or Stratified Vocational Advice Intervention. The MI-NAV Study
- ClinicalTrials.gov ID
- NCT03871712
- Acronym / sponsor ID
- MI-NAV / The MI-NAV Study
- Conditions
- Musculoskeletal Disease, Musculoskeletal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Norwegian Labour and Welfare Administration
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 12 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Musculoskeletal disorders are the main causes for sickness absence and disability benefits in Norway and the leading causes of disability worldwide. There is strong evidence that long-term sickness absence due to musculoskeletal disorders provides a poor prognosis, both in terms of work-related disability, physical and mental health, and health related quality-of-life. To assist people return to work a range of vocational rehabilitation programs exist, but the initiatives have not been able to reduce the number of people who are on sick leave due to musculoskeletal disorders. In Norway, The Norwegian Labour and Welfare Administration (NAV) case-workers have taken such approaches in use, primarily by teaching their employees with user contact in how to use Motivational Interviewing (MI). However, the evidence on the effectiveness of MI on return to work is highly uncertain. The objectives of this project are to compare the effectiveness and cost-effectiveness of usual case management alone with usual case management plus MI or usual case management plus stratified vocational advice intervention (SVAI), on RTW among people on sick leave due to musculoskeletal (MSK) disorders. All musculoskeletal diagnoses will be included. A multi-arm randomised controlled trial with 150 participants in each group will be conducted within the NAV system in Norway to evaluate these research questions.
Detailed description
The main objective of this project is to evaluate the effectiveness of usual case management plus motivational interviewing (MI), provided by trained Norwegian Labour and Welfare Administration (NAV) case-workers, and usual case management plus a Stratified Vocational Advice Intervention (SVAI), including principles of MI and vocational advice provided by trained physiotherapists, compared to usual case management alone on return to work among people on sick leave due to a musculoskeletal disorder. A multi-arm randomised controlled trial (RCT) will be conducted in order to respond to the following specific research questions:
RQ 1a Is there a difference between usual case management plus MI and usual case management alone in reducing sickness absence days at 6 months follow-up among individuals who have been on sick leave for >7 weeks due to a musculoskeletal disorder?
RQ 1b Is there a difference between usual case management plus SVAI and usual case management alone in reducing sickness absence days at 6 months follow-up among individuals who have been on sick leave for >7 weeks due to a musculoskeletal disorder?
RQ 2a Is there a difference between usual case management plus MI and usual case management alone in reducing sickness absence days at 12 months follow-up among individuals who have been on sick leave for >7 weeks due to a musculoskeletal disorder?
RQ 2b Is there a difference between usual case management plus SVAI and usual case management alone in reducing sickness absence days at 12 months follow-up among individuals who have been on sick leave for >7 weeks due to a musculoskeletal disorder?
RQ 3a Is there a difference between usual case management plus MI and usual case management alone in time until sustained RTW during 12 months follow-up among individuals who have been on sick leave for >7 weeks due to a musculoskeletal disorder?
RQ 3b Is there a difference between usual case management plus SVAI and usual case management alone in time until sustained RTW during 12 months of follow-up among individuals who have been on sick leave for >7 weeks due to a musculoskeletal disorder?
RQ 4a Is there a difference in the proportions of participants who receive sick leave benefits each month during 12 months of follow-up between usual case management plus MI compared to usual case management alone?
RQ 4b Is there a difference in the proportion of individuals who receive sick leave benefits each month during 12 months of follow-up between usual case management plus SVAI compared to usual case management alone?
RQ 5a Is there a difference in cost-effectiveness, cost-utility and cost-benefit during 6 months of follow-up between individuals on sick leave with musculoskeletal disorders who receive usual case management plus MI compared to those who receive usual case management alone?
RQ 5b Is there a difference in cost-effectiveness, cost-utility and cost-benefit during 6 months of follow-up between individuals on sick leave with musculoskeletal disorders who receive usual case management plus SVAI compared to those who receive usual case management alone?
RQ 6a Is there a difference in cost-effectiveness, cost-utility and cost-benefit during 12 months of follow-up between individuals on sick leave with musculoskeletal disorders who receive usual case management plus MI compared to those who receive usual case management alone?
RQ 6b Is there a difference in cost-effectiveness, cost-utility and cost-benefit during 12 months of follow-up between individuals on sick leave with musculoskeletal disorders who receive usual case management plus SVAI compared to those who receive usual case management alone?
RQ 7a Is there a difference in musculoskeletal health during 12 months of follow up between individuals on sick leave with musculoskeletal disorders who receive usual case management plus MI compared to those who receive usual case management alone?
RQ 7b Is there a difference in musculoskeletal health during 12 months of follow up between individuals on sick leave with musculoskeletal disorders who receive usual case management plus SVAI compared to those who receive usual case management alone?
The following hypotheses will be tested:
H 1a There is no difference in number of sickness absence days between participants who receive usual case management plus MI compared to those who receive usual case management alone at 6 months follow-up.
H 1b There is no difference in number of sickness absence days between participants who receive usual case management plus SVAI compared to those who receive usual case management alone at 6 months follow-up.
H 2a There is no difference in number of sickness absence days between participants who receive usual case management plus MI compared to those who receive usual case management alone at 12 months follow-up.
H 2b There is no difference in number of sickness absence days between participants who receive usual case management plus SVAI compared to those who receive usual case management alone at 12 months follow-up.
H 3a There is no difference in time until first sustained RTW between participants who receive usual case management plus MI compared to those who receive usual case management alone during 12 months follow-up.
H 3b There is no difference in time until first sustained RTW between participants who receive usual case management plus SVAI compared to those who receive usual case management alone during 12 months of follow-up.
H 4a There is no difference in the proportions of participants who receive sick leave benefits each month between usual case management plus MI compared to usual case management alone during 12 months of follow-up.
H 4b There is no difference in the proportions of individuals receiving sick leave benefits each month between usual case management plus SVAI compared to usual case management alone during 12 months of follow-up.
H 5a There is no difference in cost-effectiveness, cost-utility and cost-benefit between usual case management plus MI compared to usual case management alone during 6 months of follow up.
H 5b There is no difference in cost-effectiveness, cost-utility and cost-benefit between usual case management plus SVAI compared to usual case management alone during 6 months of follow up.
H 6a There is no difference in cost-effectiveness, cost-utility and cost-benefit between usual case management plus MI compared to usual case management alone during 12 months of follow up.
H 6b There is no difference in cost-effectiveness, cost-utility and cost-benefit between usual case management plus SVAI compared to usual case management alone during 12 months of follow up.
H 7a There is no difference in musculoskeletal health between participants who receive usual case management plus MI compared to those who receive usual case management alone during 12 months of follow-up.
H 7b There is no difference in musculoskeletal health between participants who receive usual case management plus SVAI compared to those who receive usual case management alone during 12 months of follow-up.
A multi-arm RCT with a full-scale health economic evaluation and mediator analysis will be conducted. In order to avoid contextual contamination effect only NAV offices in which the employees have not received any previous MI training will be included. All eligible participants will be asked to participate.
The head NAV office in Oslo will provide weely lists of persons meeting the eligibility criteria. We will contact eligible people by phone and give information about the study. Elibible persons who are interested will then receive a link to the informed consent and the baseline questionnaire.
MI intervention: In addition to usual case management, the MI group will receive 2 motivational interviews provided by a NAV case-worker. The case-workers will be educated and mentored throughout the study period. The first MI will be face-to-face, while the second may by phone, but preferable face-to-face.The interviews will be given in week 8/9 of the sick leave period, and then again after approximately 2 weeks.
SVAI intervention: In addition to usual case management, the SVAI group will be followed up by trained physical therapists. This group will be stratified into risk groups for long term sick leave; an "at risk group" and a "high risk group". The at risk group will receive 1-2 phone calls with emphasis on identifying obstacles for return to work, and solutions for resolving these obstacles. The high risk group will be followed up 3-4 times. The first follow-up is by phone, the remaining follow-ups can be either by phone or face to face meetings and can include a workplace visit. The SVAI intervention will end before week 26 of the participants' sick leave period.
Usual case management: The Norwegian welfare state has a system for following up people on sick leave, including a follow-up plan developed by the worker and the employer by week 4 of the sick leave period, a dialogue meeting between the worker and the employer by week 7, and a second dialogue Meeting including a NAV caseworker, by week 26.
The study flow:
Baseline recruitment will occur by week 8 of the sick leave period. The two interventions will start immediately after randomization and baseline assessments. The questionnaires will be sent electronic through a secure system from University of Oslo at baseline, and after 3, 6, 9, and 12 months.
A pilot study will be conducted prior to start of the RCT to test the study protocol including the recruitment procedure, the randomisation procedure, the information flow between researchers, physical therapists, NAV case workers and study participants, and the interventions (MI and SVAI). The pilot study will end by the first 100 included participants (August 31. 2019). The participants in the pilot study will be included in the RCT as long as the protocol will not be changed with respect to the scientific method and research questions (internal pilot study).
A fidelity study of the MI and SVAI interventions will be conducted to measure how well the trained personnel is using the methods and interventions as intended. For the MI arm, a developed instrument (Motivational Interviewing Treatment Integrity Coding Manual 4.2.1) will be used to score the feasibility from audio recordings of all NAV case-workers who do the MI intervention. For the SVAI intervention, feasibility will be measured by both audiotaping and from the telephone script/journal that the SVAI physiotherapists fill out during the talk with the study participant. The investigators plan to do 20-25 audiotapes of the 5 SVAI physiotherapists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A multi-arm randomised controlled trial with two intervention groups and one control group doing as usual (ordinary NAV practice). The allocation will be prepared with block randomisation for risk of long term sick leave as predicted by the Orebro Screening Questionnaire and The Keele STarT MSK Tool. Preliminary data suggests a low/medium risk group (80% of the recruited participants) and a high risk group (20%). These numbers were calculated in another study of individuals on sick leave in Norway.
| Arm | Type | Receives |
|---|---|---|
| Motivational Interview (MI) | Experimental | Behavioral: Motivational interviewIn the MI arm, a NAV case worker will meet the participants after the baseline assessment (electronic questionnaires) and randomisation and conduct the MI. The NAV case-worker will either meet (or call) again after a few weeks (anticipated 2-4 weeks) and conduct another MI. |
| Stratified vocational advice intervention (SVAI) | Active comparator | Behavioral: Stratified vocational adviceA trained physiotherapist will call the participants after the baseline assessment and randomisation. The SVAI intervention will be stratified due to the participants risk of long term sick leave estimated by the Orebro Screening Questionnaire and The Keele STarT MSK Tool. The low/moderate risk group will receive 1-2 phone calls, and the high risk group will be followed up 2-4 times. The follow-up can include face to face Meetings bewteen the Physical therapist and the participant, and also the employer and general practitioner when needed. The intervention will include an assessment of the participants obstacles for returning to work and help to develop and implement an action plan to overcome obstacles. The physical therapists' will cooperate with other health care providers and employer when needed. |
| Usual follow-up | No intervention | –This arm will be the control group receiving usual NAV follow-up. The other two groups will also receive usual NAV follow-up additionally to the interventions. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have musculoskeletal disorders
- Live in South-East Norway
- Have been on sick leave for 8 weeks with a current sick-leave status of 50%-100%
- Have a job to return to
Key exclusion criteria (5 listed)
- Have serious somatic or psychological disorders (e.g. cancer, psychotic disorders)
- Have specific disorder requiring specialized, ongoing treatment;
- Are pregnant
- Are self-employed or work free lance
- Have insufficient Norwegian or English speaking or writing skills to participate in group session and fill out questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewThe participants will be called twice with 2-4 weeks interval after the randomisation. This will be after 8 weeks of sick leave. | Behavioural | Motivational Interview (MI) |
| Stratified vocational adviceAlso: Vocational adviceThe participants will be called after the randomisation. The amount of calls/meetings will be decided after each call, but with a maximum of 4 for the high risk group. This may include physical meetings. | Behavioural | Stratified vocational advice intervention (SVAI) |
Primary outcome
Sickness absence days
Time frame: 6 months
Total number of sickness absence days up to the 6-month's follow-up
8 secondary outcomes
Sickness absence days
Time frame: 12 months
Sustainable return to work
Time frame: 12 months
Medical benefits
Time frame: 12 months
Cost-utility
Time frame: 6 months
Cost-utility
Time frame: 12 months
Cost-effectiveness
Time frame: 6 months
Cost-effectiveness
Time frame: 12 months
Musculoskeletal health
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Derived from this study: PubMed 39627785Killingmo RM, Rysstad T, Maas E, Pripp AH, Aanesen F, Tingulstad A, Tveter AT, Oiestad BE, Grotle M. Modifiable prognostic factors of high societal costs among people on sick leave due to musculoskeletal disorders: a replication study. BMC Musculoskelet Disord. 2024 Dec 3;25(1):990. doi: 10.1186/s12891-024-08132-3.
- Derived from this study: PubMed 38710259Venter M, Grotle M, Oiestad BE, Aanesen F, Tingulstad A, Rysstad T, Ferraro MC, McAuley JH, Cashin AG. Treatment Effect Modifiers for Return-to-Work in Patients With Musculoskeletal Disorders. J Pain. 2024 Sep;25(9):104556. doi: 10.1016/j.jpain.2024.104556. Epub 2024 May 6.
- Derived from this study: PubMed 37964240Tingulstad A, Maas ET, Rysstad T, Oiestad BE, Aanesen F, Pripp AH, Van Tulder MW, Grotle M. Six-month cost-effectiveness of adding motivational interviewing or a stratified vocational advice intervention to usual case management for workers with musculoskeletal disorders: the MI-NAV economic evaluation. J Occup Med Toxicol. 2023 Nov 14;18(1):25. doi: 10.1186/s12995-023-00394-2.
- Derived from this study: PubMed 36863864Cashin AG, Oiestad BE, Aanesen F, Storheim K, Tingulstad A, Rysstad TL, Lee H, McAuley JH, Sowden G, Wynne-Jones G, Tveter AT, Grotle M. Mechanisms of vocational interventions for return to work from musculoskeletal conditions: a mediation analysis of the MI-NAV trial. Occup Environ Med. 2023 May;80(5):246-253. doi: 10.1136/oemed-2022-108716. Epub 2023 Mar 2.
- Derived from this study: PubMed 36428098Aanesen F, Grotle M, Rysstad TL, Tveter AT, Tingulstad A, Lochting I, Smastuen MC, van Tulder MW, Berg R, Foster NE, Wynne-Jones G, Sowden G, Fors E, Bagoien G, Hagen R, Storheim K, Oiestad BE. Effectiveness of adding motivational interviewing or a stratified vocational advice intervention to usual case management on return to work for people with musculoskeletal disorders: the MI-NAV randomised controlled trial. Occup Environ Med. 2023 Jan;80(1):42-50. doi: 10.1136/oemed-2022-108637. Epub 2022 Nov 25.
- Derived from this study: PubMed 32723318Oiestad BE, Aanesen F, Lochting I, Storheim K, Tingulstad A, Rysstad TL, Smastuen MC, Tveter AT, Sowden G, Wynne-Jones G, Fors EA, van Tulder M, Berg RC, Foster NE, Grotle M. Study protocol for a randomized controlled trial of the effectiveness of adding motivational interviewing or stratified vocational advice intervention to usual case management on return to work for people with musculoskeletal disorders. The MI-NAV study. BMC Musculoskelet Disord. 2020 Jul 28;21(1):496. doi: 10.1186/s12891-020-03475-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hege Bentzen, PhD study director
OsloMet - Oslo Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interview and Stratified vocational advice in people with Musculoskeletal Disease and Musculoskeletal Pain, run by Oslo Metropolitan University at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sickness absence days (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03871712, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.