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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
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

Other trials in Norway

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.

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 groups in NCT05006976
Study groupRoleWhat they receive
NSAC health onlyActive comparatorTreatment 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 + MBWExperimentalTreatment 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.

  1. 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)

  2. 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

  3. 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

  4. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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.

  1. First posted16 Aug 2021
  2. Study start6 Sep 2021
  3. Primary completion12 Apr 2028 (estimated)
  4. Study completion12 Jan 2033 (estimated)

Resources

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)
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 41680726
  • Bardal 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 41385138
  • Aars 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

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.

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