Musculoskeletal DisorderNSACNCT05006976
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
A study testing NSAC health only and NSAC health + MBW in people with Musculoskeletal Disorder and Anxiety Disorders, run by Nordlandssykehuset HF at 5 sites in Norway.
Trial summary
The Norwegian Sickness Absence Clinic (NSAC) Nudge Study is a naturalistic randomized controlled multicentre trial which aim is to measure the efficacy of nudging clinicians' attention towards patients' motivation for work, barriers for return to work and work environment challenges, on functional recovery as primary… Read more about this study
- Who is it for?
- Ages 23 years and older
- Conditions the study is for
- Musculoskeletal Disorder, Anxiety Disorders, Depression
- What is being tested?
- NSAC health only and NSAC health + MBW
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,180 participants
- Where
- 5 sitesNorway
- Study dates
- 6 Sep 2021to 12 Jan 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 23 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For the study, the single inclusion criteria is that the patient is offered a consultation or treatment at the NSAC (Norwegian: HiA).
Who cannot join
- Aged younger than 23 years at time of referral. The NSACs have guidelines that describe eligibility for treatment, and excludes patients that are either too healthy for the measure, too sick for the measure, not relevant diagnosis or otherwise not considered being in the target group for the measure.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Norway5 sites
Opptreningssenteret i Finnmark
Alta, Troms Og Finnmark, 9510
Helse I Arbeid Nordlandssykehuset
Bodø, Nordland, 8092
Helse I Arbeid Finnmarkssykehuset
Kirkenes, Troms Og Finnmark, 9915
Helse I Arbeid Helgelandssykehuset
Sandnessjøen, Nordland, 8800
Helse I Arbeid Universitetssykehuset Nord-Norge
Tromsø, Troms Og Finnmark, 9019
About this study
Official title: A Naturalistic Trial of Nudging Patients and Clinicians in the Norwegian Sickness Absence Clinics- The NSAC Nudge Study
The Norwegian Sickness Absence Clinic (NSAC) Nudge Study is a naturalistic randomized controlled multicentre trial which aim is to measure the efficacy of nudging clinicians' attention towards patients' motivation for work, barriers for return to work and work environment challenges, on functional recovery as primary outcome, and health outcomes as secondary outcome.
Patients will be recruited in five different NSACs across northern Norway. In total 1100 patients will be randomized to two equal probability treatment arms: 1) NSAC with the nudge, and 2) NSAC without the nudge. The nudge is tailored to the individual patient's needs using survey, and the clinicians are presented with a summary of this patient survey prior to consultations highlighting health problems and challenges as reported by the patient in the survey.
Read the detailed description
The NSAC Nudge Study is part of a broader project, the Norwegian Sickness Absence Clinic Study (NSACS). The NSACS has two sources of funding (Northern Norway Regional Health Authority and The Norwegian Labour and Welfare Administration (NAV)), and involves two RCTs (NSAC Nudge and NSAC Efficacy) and fifteen work packages covering aspects of efficacy, interactions in efficacy, scalability, health economics, and characteristics of the target group and the patient group. The randomized controlled trial (RCT) NSAC Nudge is the subject of this trial registration. A list of the associated work-packages (WPs) is available in the protocol attached this registration at a later time point.
The NSAC Nudge Study is a randomized controlled multicentre trial, carried out in northern Norway and involving 5 Norwegian Sickness Absence Clinics (NSAC [Helse i Arbeid]). The study will recruit 1100 patients, randomized in equal proportions to either of two treatment arms 1) Treatment at the NSAC following a patient survey of health problems and 2) treatment at the NSAC following a patient survey of health problems as well as a survey on motivation for work, barriers for return to work and work environment (MBW).
The NSACs are staffed by teams of medical doctors specializing in physical medicine and rehabilitation, psychologists, physiotherapists and employment support supervisors. The NSAC service aims to provide quick clarification of health problems or treatment to patients with common mental disorders or musculoskeletal health problems with the goals of functional improvement, prevention of long-term sickness absence and return to work.
All patients are asked to fill out an online survey about their health and MBW factors between time of referral and their first treatment. The survey will also handle randomization. The NSAC clinicians are given a summary to be used in the treatment of the individual patient, and the effect of this comprehensive mapping and the provision of a condensed report to clinician prior to consultation is the primary aim of the RCT. The clinicians will be trained in how providing this information is going to guide clinical practice and using this information in treatment of patients.
The anticipated mechanism of the nudge is 1) an increased expectation among patients that MBW factors will be addressed during treatment, and/or 2) an increased focus on MBW factors by clinician in treatment, both due to the report and the patients' expectations. Whether this mechanism has an effect on patients' return to work (RTW) outcomes, prevention of sickness absence and general alleviation of symptoms will also be explored.
The data necessary to answer the research questions are gathered from national registries via personal identifier, registry data on population level, questionnaires filled out by the patient (data on health and working conditions) and questionnaires filled out by the clinician after each consultation (data on number of treatments, diagnosis, professions involved and types of treatment provided).
The patient questionnaire is divided in two surveys; 1) a health survey and 2) a survey on health and MBW. The health survey covers health, and includes musculoskeletal problems, mental health and other health related issues (such as alcohol consumption, medication and physical activity). The MBW survey includes working conditions (including inter alia questions on social support, work/family conflict and bullying), barriers for RTW, labour market affiliation, other personal aspects (such as demography and motivation for work), questionnaires for health economic evaluation and expectations for treatment.
By and large the questionnaire consists of test batteries which have been validated for specific topics. In an effort to reduce the number of questions posed to each patient, the baseline questionnaire will employ index questions which have proven psychometric properties in terms of factor loading or similar, meaning that if a problem on a specific topic such as neck pain is not indicated, the patient will not be presented with the Neck Disability Index questionnaire. The patient questionnaires will be filled out electronically after referral and prior to first treatment (Baseline, Time 0), as well as at 6 months after baseline (Time 1). We planned for a 12-month follow-up survey, but because of a technical error this second survey was never sent to participants. Accordingly the second follow-up survey will be sent to participants ultimo June 2024, which is in the interval between 17- and 31 months (depending on date of recruitment) after time of baseline survey (Time 2).
In the NSAC Nudge Study, receiving treatment at NSAC (Norwegian name HiA) does not presuppose consent to participate in research, but a mapping of health status is nevertheless a mandatory part of treatment. However, participation in research requires sharing these data and access to registry-based data for the involved patients.
- Conditions
- Musculoskeletal Disorder, Anxiety Disorders, Depression, Fatigue, Pain, Occupational Exposure
- Being tested
- NSAC health only, NSAC health + MBW
- Keywords
- Return to work, Sickness absence, Nudge, Barriers for return to work, Motivation for work, Demand and control, Work/family conflict, Bullying
- Medical subject headings
- Musculoskeletal Diseases, Anxiety Disorders, Depression, Fatigue, Pain, Occupational Stress, Bullying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSAC health onlyOther
NSAC is an outpatient service delivered under the auspices of the specialist health care sector to patients currently on sick leave or at risk for long-term sickness absence. The service is staffed by medical doctors specialising in musculoskeletal health, physiotherapists, psychologists and welfare sector counsellors, and aims to provide patients with multi-disciplinary treatment with the intent of functional recovery. In "NSAC health only", clinicians are provided survey information on potential health problems only.
NSAC health + MBWOther
NSAC is an outpatient service delivered under the auspices of the specialist health care sector to patients currently on sick leave or at risk for long-term sickness absence. The service is staffed by medical doctors specialising in musculoskeletal health, physiotherapists, psychologists and welfare sector counsellors, and aims to provide patients with multi-disciplinary treatment with the intent of functional recovery. In "NSAC health + MBW" clinicians are provided survey information on potential health problems as well as information on motivation for work, barriers for return to work and work environment factors.
| Study group | Role | What they receive |
|---|---|---|
| NSAC health only | Active comparator | Treatment as usual (TAU) at NSAC, following a digital survey of health problems and the provision of a condensed report of this survey to clinician prior to consultation. Receives: Other: NSAC health only |
| NSAC health + MBW | Experimental | Treatment as usual (TAU) at NSAC, following a digital survey of health problems as well as Motivation, Barriers for return to work and Work environment (MBW), and the provision of a condensed report of this survey to clinician prior to consultation. Receives: Other: NSAC health + MBW |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional recovery: status, plan and prognosis for employment versus sickness absence
Clinician report at last consultation of current status, plan and prognosis for patient employment versus sickness absence. Status is current employment versus sickness absence, plan refers to patients own ambition and plans for employment versus sickness absence short term, while prognosis refers to the clinicians assessment of prognosis for employment versus sickness absence in 12 months.
Measured: At last appointment at NSAC (can vary substantially between patients, but generally < 3 months after first appointment at NSAC)
Functional recovery: sickness absence self-report
Employment, sickness absence and application for rehabilitation benefits between Time 0 and Time 2, based on patient self-report.
Measured: Up to 31 months post baseline survey
Functional recovery: sickness absence registry data
Employment, sickness absence and application for rehabilitation benefits during first 365 days post baseline survey, based on registry data.
Measured: 12 months post baseline survey
Functional recovery: disability benefits
Employment, sickness absence, rehabilitation benefits and disability benefits during 5-year period post baseline survey, all based on registry data.
Measured: 60 months post baseline survey
Secondary outcomes (15)
Mental health
Changes in self-reported mental health between Time 0 and Time 1, and between Time 0 and Time 2, measured using the Hopkins Symptoms Checklist - 10 (HSCL-10).
Measured: Up to 31 months post baseline survey
Anxiety
Changes in self-reported anxiety between Time 0 and Time 1, and between Time 0 and Time 2, measured using the Beck Anxiety Inventory (BAI). The instrument is provided to patients upon indication, defined as a HSCL-10 score > 1.4
Measured: Up to 31 months post baseline survey
Depressive symptoms
Changes in self-reported depression between Time 0 and Time 1, and between Time 0 and Time 2, measured using the Beck Depression Inventory (BDI). The instrument is provided to patients upon indication, defined as a HSCL-10 score > 1.4
Measured: Up to 31 months post baseline survey
Sleep
Changes in self-reported sleep between Time 0 and Time 1, and between Time 0 and Time 2, measured using 3 questions commonly used to diagnose sleeping disorder according to the DSM-IV criteria for insomnia.
Measured: Up to 31 months post baseline survey
Health Anxiety
Changes in self-reported health anxiety between Time 0 and Time 1, and between Time 0 and Time 2, measured using the Whitely Index. All patients are asked the first question in the test battery, and the entire instrument is provided to patients with a score of >3 on this question
Measured: Up to 31 months post baseline survey
Subjective health complaints
Changes in subjective health between Time 0 and Time 1, and between Time 0 and Time 2, measured using a modified version of the Ursin Health Inventory.
Measured: Up to 31 months post baseline survey
Back pain
Changes in self-reported back pain Time 0 and Time 1, and between Time 0 and Time 2, measured using the Oswestry Disability Index (ODI). All patients are asked whether they suffer from musculoskeletal pain, and if present, they are provided questions on localization of pain. In case of back pain, patients are provided the ODI.
Measured: Up to 31 months post baseline survey
Neck pain
Changes in self-reported neck pain between Time 0 and Time 1, and between Time 0 and Time 2, measured using the Neck Disability Index (NDI). All patients are asked whether they suffer from musculoskeletal pain, and if present, they are provided questions on localization of pain. In case of neck pain, patients are provided the NDI.
Measured: Up to 31 months post baseline survey
Pain intensity
Changes in self-reported pain intensity between Time 0 and Time 1, and between Time 0 and Time 2, measured using a visual analogue scale scored between 0 and 10. All patients are asked whether they suffer from musculoskeletal pain, and if present, they are provided questions on pain intensity during rest and activity.
Measured: Up to 31 months post baseline survey
Fear avoidance
Changes in self-reported fear avoidance between Time 0 and Time 1, and between Time 0 and Time 2, measured using the Fear Avoidance Beliefs Questionnaire (FABQ). All patients are asked whether they suffer from musculoskeletal pain, and if present, they are provided the FABQ.
Measured: Up to 31 months post baseline survey
Physical activity
Changes in self-reported level of physical between Time 0 and Time 1, and between Time 0 and Time 2, measured using the Saltin-Grimby Physical Activity Level Scale (SGPALS).
Measured: Up to 31 months post baseline survey
Fatigue
Changes in self-reported fatigue between Time 0 and Time 1, and between Time 0 and Time 2, measured using the Fatigue Assessment Scale. All patients are asked the first question in the test battery, and the entire instrument is provided to patients with a score of ≥ 3 on this question
Measured: Up to 31 months post baseline survey
Pain localization
Changes in self-reported localization of pain between Time 0 and Time 1, and between Time 0 and Time 2. All patients are asked whether they suffer from musculoskeletal pain, and if present, they are provided questions on localization of pain.
Measured: Up to 31 months post baseline survey
Cause of pain
Changes in self-reported cause of pain between Time 0 and Time 1, and between Time 0 and Time 2. All patients are asked whether they suffer from musculoskeletal pain, and if present, they are provided questions on the believed cause of pain.
Measured: Up to 31 months post baseline survey
Self-reported diagnoses
Changes in self-reported diagnoses between Time 0 and Time 1, and between Time 0 and Time 2. The respondent is asked whether he/she thinks they have Covid-19 sequelae, myalgic encephalomyelitis/chronic fatigue syndrome, whiplash, fibromyalgia, hypermobility, irritable bowel syndrome or food intolerance, or whether they have been diagnosed with either of these by health personnel.
Measured: Up to 31 months post baseline survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start6 Sep 2021
- Primary completion12 Apr 2028 (estimated)
- Study completion12 Jan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DisorderStudies 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
- Patients are randomized in equal proportions to fill out either of two different questionnaires, consisting either of 1) health related questions only or 2) health related questions as well as questions concerning motivation for work, barriers for return to work and work environment. In both treatment arms, clinicians receive a summary of patient survey information on mental health and musculoskeletal pain. In the intervention arm, clinicians are nudged to have particular attention towards motivation for work, barriers for return to work and work environment.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordlandssykehuset HF
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of North Norway, Opptreningssenteret i Finnmark (Alta, Norway), Helgeland Hospital Trust, Finnmarkssykehuset HF (Kirkenes, Norway), UiT The Arctic University of Norway
- Responsible party
- Sponsor
- Investigators
- Arnstein Mykletun, PhD, Principal investigator, UiT The Arctic University of Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006976
- Sponsor's protocol ID
- NSAC Nudge
- Acronym
- NSAC
- Status last verified
- Jun 2025
- First submitted
- 9 Aug 2021
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual patient data with other researchers. At the stage of analyses, associated researchers will be provided with an anonymized data set including all relevant data to answer the research questions.
Publications
Myhrer M, Brinchmann B, Trichet L, Aars NA, Mykletun A. Barriers for return to work as an iatrogenic effect of sickness absence: a proposed conceptual framework and questionnaire based on a cross-sectional study. BMC Public Health. 2026 Feb 12;26(1):920. doi: 10.1186/s12889-026-26584-1.
PubMed 41680726Bardal I, Aars NAP, Trichet LO, Brandseth OL, Terjesen C, Irgens E, Hansen BO, Kristoffersen A, Hoper A, Jenssen OR, Brinchmann B, Mykletun A. Expanding the Focus on Work Factors in an Outpatient Setting: Does a Nudge of Patients and Clinicians have an Effect on Return-to-Work and Benefits? Findings from the NSAC Nudge Multicentre Randomised Controlled Trial. J Occup Rehabil. 2025 Dec 12. doi: 10.1007/s10926-025-10343-x. Online ahead of print.
PubMed 41385138Aars NA, Bardal I, Brinchmann B, Mykletun A. Naturalistic trial of nudging patients and clinicians in the Norwegian sickness absence clinics: a study protocol for the NSAC Nudge Study. BMJ Open. 2025 Mar 3;15(3):e089758. doi: 10.1136/bmjopen-2024-089758.
PubMed 40032398
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Naturalistic Trial of Nudging Patients and Clinicians in the Norwegian Sickness Absence Clinics- The NSAC Nudge Study
- ClinicalTrials.gov ID
- NCT05006976
- Acronym / sponsor ID
- NSAC / NSAC Nudge
- Conditions
- Musculoskeletal Disorder, Anxiety Disorders, Depression, Fatigue, Pain, Occupational Exposure
- Keywords
- Return to work, Sickness absence, Nudge, Barriers for return to work, Motivation for work, Demand and control, Work/family conflict, Bullying
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,180 participants (actual)
- Lead sponsor
- Nordlandssykehuset HFUniversity, hospital or other
- Collaborators
- University Hospital of North Norway, Opptreningssenteret i Finnmark (Alta, Norway), Helgeland Hospital Trust, Finnmarkssykehuset HF (Kirkenes, Norway), UiT The Arctic University of Norway
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 12 Apr 2028 (estimated)
- Study completion
- 12 Jan 2033 (estimated)
- First posted
- 16 Aug 2021 (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.
The Norwegian Sickness Absence Clinic (NSAC) Nudge Study is a naturalistic randomized controlled multicentre trial which aim is to measure the efficacy of nudging clinicians' attention towards patients' motivation for work, barriers for return to work and work environment challenges, on functional recovery as primary outcome, and health outcomes as secondary outcome.
Patients will be recruited in five different NSACs across northern Norway. In total 1100 patients will be randomized to two equal probability treatment arms: 1) NSAC with the nudge, and 2) NSAC without the nudge. The nudge is tailored to the individual patient's needs using survey, and the clinicians are presented with a summary of this patient survey prior to consultations highlighting health problems and challenges as reported by the patient in the survey.
Detailed description
The NSAC Nudge Study is part of a broader project, the Norwegian Sickness Absence Clinic Study (NSACS). The NSACS has two sources of funding (Northern Norway Regional Health Authority and The Norwegian Labour and Welfare Administration (NAV)), and involves two RCTs (NSAC Nudge and NSAC Efficacy) and fifteen work packages covering aspects of efficacy, interactions in efficacy, scalability, health economics, and characteristics of the target group and the patient group. The randomized controlled trial (RCT) NSAC Nudge is the subject of this trial registration. A list of the associated work-packages (WPs) is available in the protocol attached this registration at a later time point.
The NSAC Nudge Study is a randomized controlled multicentre trial, carried out in northern Norway and involving 5 Norwegian Sickness Absence Clinics (NSAC [Helse i Arbeid]). The study will recruit 1100 patients, randomized in equal proportions to either of two treatment arms 1) Treatment at the NSAC following a patient survey of health problems and 2) treatment at the NSAC following a patient survey of health problems as well as a survey on motivation for work, barriers for return to work and work environment (MBW).
The NSACs are staffed by teams of medical doctors specializing in physical medicine and rehabilitation, psychologists, physiotherapists and employment support supervisors. The NSAC service aims to provide quick clarification of health problems or treatment to patients with common mental disorders or musculoskeletal health problems with the goals of functional improvement, prevention of long-term sickness absence and return to work.
All patients are asked to fill out an online survey about their health and MBW factors between time of referral and their first treatment. The survey will also handle randomization. The NSAC clinicians are given a summary to be used in the treatment of the individual patient, and the effect of this comprehensive mapping and the provision of a condensed report to clinician prior to consultation is the primary aim of the RCT. The clinicians will be trained in how providing this information is going to guide clinical practice and using this information in treatment of patients.
The anticipated mechanism of the nudge is 1) an increased expectation among patients that MBW factors will be addressed during treatment, and/or 2) an increased focus on MBW factors by clinician in treatment, both due to the report and the patients' expectations. Whether this mechanism has an effect on patients' return to work (RTW) outcomes, prevention of sickness absence and general alleviation of symptoms will also be explored.
The data necessary to answer the research questions are gathered from national registries via personal identifier, registry data on population level, questionnaires filled out by the patient (data on health and working conditions) and questionnaires filled out by the clinician after each consultation (data on number of treatments, diagnosis, professions involved and types of treatment provided).
The patient questionnaire is divided in two surveys; 1) a health survey and 2) a survey on health and MBW. The health survey covers health, and includes musculoskeletal problems, mental health and other health related issues (such as alcohol consumption, medication and physical activity). The MBW survey includes working conditions (including inter alia questions on social support, work/family conflict and bullying), barriers for RTW, labour market affiliation, other personal aspects (such as demography and motivation for work), questionnaires for health economic evaluation and expectations for treatment.
By and large the questionnaire consists of test batteries which have been validated for specific topics. In an effort to reduce the number of questions posed to each patient, the baseline questionnaire will employ index questions which have proven psychometric properties in terms of factor loading or similar, meaning that if a problem on a specific topic such as neck pain is not indicated, the patient will not be presented with the Neck Disability Index questionnaire. The patient questionnaires will be filled out electronically after referral and prior to first treatment (Baseline, Time 0), as well as at 6 months after baseline (Time 1). We planned for a 12-month follow-up survey, but because of a technical error this second survey was never sent to participants. Accordingly the second follow-up survey will be sent to participants ultimo June 2024, which is in the interval between 17- and 31 months (depending on date of recruitment) after time of baseline survey (Time 2).
In the NSAC Nudge Study, receiving treatment at NSAC (Norwegian name HiA) does not presuppose consent to participate in research, but a mapping of health status is nevertheless a mandatory part of treatment. However, participation in research requires sharing these data and access to registry-based data for the involved patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are randomized in equal proportions to fill out either of two different questionnaires, consisting either of 1) health related questions only or 2) health related questions as well as questions concerning motivation for work, barriers for return to work and work environment. In both treatment arms, clinicians receive a summary of patient survey information on mental health and musculoskeletal pain. In the intervention arm, clinicians are nudged to have particular attention towards motivation for work, barriers for return to work and work environment.
| Arm | Type | Receives |
|---|---|---|
| NSAC health only | Active comparator | Other: NSAC health onlyTreatment as usual (TAU) at NSAC, following a digital survey of health problems and the provision of a condensed report of this survey to clinician prior to consultation. |
| NSAC health + MBW | Experimental | Other: NSAC health + MBWTreatment as usual (TAU) at NSAC, following a digital survey of health problems as well as Motivation, Barriers for return to work and Work environment (MBW), and the provision of a condensed report of this survey to clinician prior to consultation. |
Who may qualify
- Ages
- 23 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- For the study, the single inclusion criteria is that the patient is offered a consultation or treatment at the NSAC (Norwegian: HiA).
Key exclusion criteria (1 listed)
- Aged younger than 23 years at time of referral. The NSACs have guidelines that describe eligibility for treatment, and excludes patients that are either too healthy for the measure, too sick for the measure, not relevant diagnosis or otherwise not considered being in the target group for the measure.
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 |
|---|---|---|
| NSAC health onlyNSAC is an outpatient service delivered under the auspices of the specialist health care sector to patients currently on sick leave or at risk for long-term sickness absence. The service is staffed by medical doctors specialising in musculoskeletal health, physiotherapists, psychologists and welfare sector counsellors, and aims to provide patients with multi-disciplinary treatment with the intent of functional recovery. In "NSAC health only", clinicians are provided survey information on potential health problems only. | Other | NSAC health only |
| NSAC health + MBWNSAC is an outpatient service delivered under the auspices of the specialist health care sector to patients currently on sick leave or at risk for long-term sickness absence. The service is staffed by medical doctors specialising in musculoskeletal health, physiotherapists, psychologists and welfare sector counsellors, and aims to provide patients with multi-disciplinary treatment with the intent of functional recovery. In "NSAC health + MBW" clinicians are provided survey information on potential health problems as well as information on motivation for work, barriers for return to work and work environment factors. | Other | NSAC health + MBW |
Primary outcome
Functional recovery: status, plan and prognosis for employment versus sickness absence
Time frame: At last appointment at NSAC (can vary substantially between patients, but generally < 3 months after first appointment at NSAC)
Clinician report at last consultation of current status, plan and prognosis for patient employment versus sickness absence. Status is current employment versus sickness absence, plan refers to patients own ambition and plans for employment versus sickness absence short term, while prognosis refers to the clinicians assessment of prognosis for employment versus sickness absence in 12 months.
Functional recovery: sickness absence self-report
Time frame: Up to 31 months post baseline survey
Employment, sickness absence and application for rehabilitation benefits between Time 0 and Time 2, based on patient self-report.
Functional recovery: sickness absence registry data
Time frame: 12 months post baseline survey
Employment, sickness absence and application for rehabilitation benefits during first 365 days post baseline survey, based on registry data.
Functional recovery: disability benefits
Time frame: 60 months post baseline survey
Employment, sickness absence, rehabilitation benefits and disability benefits during 5-year period post baseline survey, all based on registry data.
15 secondary outcomes
Mental health
Time frame: Up to 31 months post baseline survey
Anxiety
Time frame: Up to 31 months post baseline survey
Depressive symptoms
Time frame: Up to 31 months post baseline survey
Sleep
Time frame: Up to 31 months post baseline survey
Health Anxiety
Time frame: Up to 31 months post baseline survey
Subjective health complaints
Time frame: Up to 31 months post baseline survey
Back pain
Time frame: Up to 31 months post baseline survey
Neck pain
Time frame: Up to 31 months post baseline survey
Pain intensity
Time frame: Up to 31 months post baseline survey
Fear avoidance
Time frame: Up to 31 months post baseline survey
Physical activity
Time frame: Up to 31 months post baseline survey
Fatigue
Time frame: Up to 31 months post baseline survey
Pain localization
Time frame: Up to 31 months post baseline survey
Cause of pain
Time frame: Up to 31 months post baseline survey
Self-reported diagnoses
Time frame: Up to 31 months post baseline survey
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 41680726Myhrer M, Brinchmann B, Trichet L, Aars NA, Mykletun A. Barriers for return to work as an iatrogenic effect of sickness absence: a proposed conceptual framework and questionnaire based on a cross-sectional study. BMC Public Health. 2026 Feb 12;26(1):920. doi: 10.1186/s12889-026-26584-1.
- Derived from this study: PubMed 41385138Bardal I, Aars NAP, Trichet LO, Brandseth OL, Terjesen C, Irgens E, Hansen BO, Kristoffersen A, Hoper A, Jenssen OR, Brinchmann B, Mykletun A. Expanding the Focus on Work Factors in an Outpatient Setting: Does a Nudge of Patients and Clinicians have an Effect on Return-to-Work and Benefits? Findings from the NSAC Nudge Multicentre Randomised Controlled Trial. J Occup Rehabil. 2025 Dec 12. doi: 10.1007/s10926-025-10343-x. Online ahead of print.
- Derived from this study: PubMed 40032398Aars NA, Bardal I, Brinchmann B, Mykletun A. Naturalistic trial of nudging patients and clinicians in the Norwegian sickness absence clinics: a study protocol for the NSAC Nudge Study. BMJ Open. 2025 Mar 3;15(3):e089758. doi: 10.1136/bmjopen-2024-089758.
- Individual participant dataSharing planned: No. There are no plans to share individual patient data with other researchers. At the stage of analyses, associated researchers will be provided with an anonymized data set including all relevant data to answer the research questions.
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Rotator Cuff Tendonitis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
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.
Arnstein Mykletun, PhD principal investigator
UiT The Arctic University of Norway
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NSAC health only and NSAC health + MBW in people with Musculoskeletal Disorder and Anxiety Disorders, run by Nordlandssykehuset HF at 5 sites 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Functional recovery: status, plan and prognosis for employment versus sickness absence (time frame: At last appointment at NSAC (can vary substantially between patients, but generally < 3 months after first appointment at NSAC)). The study lists 4 primary outcomes in all. 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 NCT05006976, which also lists 3 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 13 Apr 2026.