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Work-Related Musculoskeletal DisordersHUMLANCT07805629

Reducing Physical Workload Among Assistant Nurses Through Ergonomic Work Technique Training With or Without Biofeedback

A study testing Group A. Patient handling and movement training and Group B: Patient handling and movement training plus biofeedback in people with Work-Related Musculoskeletal Disorders, run by Linkoeping University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Assistant nurses often develop work-related pain in the back, neck and shoulders because their work involves frequent patient handling and movement. Training in safe patient handling may help reduce pain and injury risk, and biofeedback may further support better work techniques during everyday care work. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Work-Related Musculoskeletal Disorders
What is being tested?
Group A. Patient handling and movement training and Group B: Patient handling and movement training plus biofeedback
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
18 Jan 2027to 31 Dec 2028
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Female assistant nurses (AN)
  • Employed in/ work in hospital inpatient care or residential care settings
  • Employment in south-east Sweden within the counties of Östergötland and Jönköping
  • Have at least one year of work experience as AN
  • Permanent employmentReport musculoskeletal symptoms in the neck/shoulder region and/or back;
  • Have average pain intensity of at least 3/10 on the NRS during the preceding week

Who cannot join

  • Currently on sick leave;
  • Are receiving other ongoing treatment for their musculoskeletal condition
  • Have a disorder considered unrelated to their work

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Anneli Peolsson, Professor, PhD contact

+4613284601

anneli.peolsson@liu.se

Charlotte Wåhlin, Assoc. Prof., PhD contact

+46722396640

Charlotte.Wahlin@liu.se

About this study

Official title: Reducing Physical Workload Among Assistant Nurses Through Ergonomic Work Technique Training With or Without Biofeedback: Study Protocol for a Multicentre Randomised Controlled Trial

Assistant nurses often develop work-related pain in the back, neck and shoulders because their work involves frequent patient handling and movement. Training in safe patient handling may help reduce pain and injury risk, and biofeedback may further support better work techniques during everyday care work.

This study will test whether workplace-based training in patient handling can reduce musculoskeletal problems among assistant nurses. It will also examine whether adding six weeks of self-managed biofeedback-supported work technique training gives extra benefits compared with patient handling training alone. The study will include 60 assistant nurses with musculoskeletal symptoms, who will be randomly assigned to one of the two training groups. Data will be collected through interviews, physical assessments, questionnaires at baseline, six weeks and six months, and weekly SMS monitoring. Interviews with assistant nurses and managers will also explore how the intervention works in practice, how safe patient handling can be promoted, and what organisational factors support safer working methods.

Read the detailed description

Introduction: Assistant nurses (AN) are at high risk of work-related musculoskeletal disorders (WMSD) affecting the back and neck/shoulder region. Patient handling and movement (PHM) competence and safe working methods may reduce symptoms and injury risk. Biofeedback may further support the acquisition of more sustainable work techniques. However, early workplace-based interventions using biofeedback during ordinary care work remain insufficiently explored. The aim of the study is to evaluate whether early workplace-based interventions focused on PHM competence can reduce WMSD among AN. Another aim is to examine whether self-administered work technique training supported by biofeedback provides additional benefits beyond PHM competence training alone. Furthermore, we aim to explore managers' experiences of promoting workplace safety within nursing assistants' caregiving practice.

Methods and analysis: This is a multicentre, prospective, longitudinal, two-arm randomised controlled trial in which 60 AN with WMSD will be included. After providing written informed consent, participants will be randomised to PHM training alone or PHM training plus six weeks of self-administered biofeedback-supported work technique training. Data will be collected through clinical interviews, functional screening, and physical measures. Questionnaires will be completed at baseline, six weeks and six months. Weekly SMS-based monitoring will be conducted throughout the intervention period. Semi-structured interviews with AN and managers will explore experiences of the intervention, feasibility, implementation and organisational conditions for safe PHM. Quantitative data will be analysed using parametric or non-parametric methods, as appropriate, and interview data using inductive qualitative content analysis.

Ethics and dissemination: Ethical approval was obtained from the Swedish Ethical Review Authority (2027-4422-01). All participants will provide written informed consent before participation. Data will be handled confidentially, stored securely and reported in non-identifiable form in accordance with the Declaration of Helsinki and the General Data Protection Regulation. Findings will be disseminated to healthcare, stakeholders, and students, and through scientific publications and presentations.

Following participant approval, managers will receive an information letter describing the study and its requirements. Because participation will take place during working hours, approval from the participant's immediate manager is required. Managers of participating AN will also be invited to participate after providing written informed consent; the number of managers is not predetermined, as more than one nursing assistant may be recruited from each workplace.

Each participant's manager will be provided with information regarding the study design and will receive educational material focused on ergonomics and PHM competence. Both participants and their managers will have access to project support and may contact the research team with questions throughout the study period.

Being tested
Group A. Patient handling and movement training, Group B: Patient handling and movement training plus biofeedback
Keywords
musculoskeletal disorders, nursing assistants, patient transfers, ergonomics, biofeedback, occupational health, workplace intervention, randomised controlled trial
Medical subject headings
Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group A. Patient handling and movement trainingOther

    Both groups: Participants in Groups A and B will receive individualised ergonomic advice tailored to their work situation and needs. During the first weeks, they will complete a digital educational programme delivered through the county council of Östergötland's educational platform and receive a five-step checklist for safe patient handling and movement (PHM), based on Safe Patient Handling - A Research-Based Guide for an Improved Work Environment. The programme includes theoretical and practical PHM training, with emphasis on risk assessment, safe patient transfers and other physically demanding work tasks. Practical instruction will also be provided in the participants' own workplaces.

  • Group B: Patient handling and movement training plus biofeedbackOther

    Biofeedback-supported work technique training (Group B): Participants in Group B will additionally receive six weeks of self-administered work technique training supported by biofeedback (Wergonic AB, Tullinge, Sweden). Wearable inertial measurement unit sensors attached to the trunk and upper arm will monitor working postures during routine care work, particularly movements involving the back and neck/shoulder region (34, 35) (Figure 2). When unfavourable postures are detected, the system provides gentle vibrotactile feedback, which increases with less favourable postures and stops when a more ergonomic posture is adopted. After instruction, participants will use the system independently during normal work to practise less physically demanding work techniques. They will complete at least ten sessions of a minimum of 20 minutes over six weeks, with the option to train more frequently or for longer periods.

Study groups in NCT07805629
Study groupRoleWhat they receive
Group A. Patient handling and movement trainingActive comparatorParticipants in both Groups A and B will during the first weeks receive a digital educational programme comprising modules delivered through educational platform of the county council of Östergötland. In addition, participants will receive a five-step checklist describing safe PHM, based on Safe Patient Handling - A Research-Based Guide for an Improved Work Environment. The educational content emphasises theoretical and practical training in PHM competence, including the importance of conducting risk assessments and evaluating risks associated with each patient transfer and other physically demanding work tasks. Participants will also receive practical instruction in PHM techniques within their own workplace.
Receives: Other: Group A. Patient handling and movement training
Group B. Patient handling and movement training plus biofeedbackActive comparatorGroup B. As described above plus Biofeedback-supported work technique training. Participants in Group B will receive six weeks of self-administered biofeedback-supported work technique training in addition to PHM training. The system uses inertial measurement unit sensors attached to the trunk and upper arm to monitor back and arm postures during routine work activities, with particular focus on the neck/shoulder region and back (34, 35) (Figure 2). When unfavourable postures are detected, participants receive gentle vibratory feedback, increasing with less favourable postures and stopping when more ergonomic postures are adopted. After instruction and practical training, participants will use the system independently during ordinary work tasks to develop more ergonomic and less physically demanding techniques. The minimum dose is 10 sessions of at least 20 minutes over six weeks, although participants may complete longer or additional sessions if they wish.
Receives: Other: Group B: Patient handling and movement training plus biofeedback

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain intensity

    Pain: Overall work-related musculoskeletal disorders current pain intensity in the back/neck/shoulder will be measured using the Numeric Rating Scale (NRS 0-10, higher levels indicate more severe pain). One score for the whole area.

    Measured: Baseline, 6-week, 6-month

  2. Work technique

    Participating AN will receive a weekly SMS question: "How well has your work technique functioned this week in relation to safe patient handling and movement? (0 = not at all well; 10 = very well)."

    Measured: During the intervention period, every week from baseline to six months follow-up.

Secondary outcomes (20)
  1. Health related quality of life

    Health-related quality of life will be assessed using the EQ-5D-5L Swedish version (permission to be used Aug. 18, 2026, tracking number 87167). The instrument consists of five questions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression (1 = no problem; 5= unable to extreme problems). The health state is defined by combining one level from each of the five dimensions to an index score (0.31 = the worst to 1 = the best) health state. This is one instrument, the results of the instrument is presented as an index score only according to the EQ manual and as commonly used.

    Measured: Baseline, 6 week, 6 month

  2. EQ-VAS

    EQ-VAS (vertical thermometer) (0 = the worst health you can imagine; 100 = the best health you can imagine). (Permission to be used Aug. 18, 2026, tracking number 87167.)

    Measured: Baseline, 6 weeks, 6 month

  3. Neck Disability Index

    The impact of neck pain on daily life will be evaluated using the Neck Disability Index (NDI) (percentage from 0% to 100%, with higher scores indicating greater neck-related disability).

    Measured: Baseline, 6 week, 6 month

  4. QuickDASH-7

    Upper limb function will be assessed using the modified QuickDASH-7 (0 = no disability; 100 = most severe disability)

    Measured: Baseline, 6 week, 6 month

  5. Oswestry Low Back Pain Questionnaire

    Functional limitations related to low back pain will be assessed using the Oswestry Low Back Pain Questionnaire version 2.1 (percentage from 0% to 100%, with higher scores indicating greater low-back-related disability).

    Measured: Baseline, 6 week, 6 month

  6. Work ability

    Work ability will be assessed using Question 1 of the Work Ability Index (WAI) (0 = completely unable to work; 10 = work ability at its lifetime best).

    Measured: Baseline, 6 week, 6 month

  7. Multidisciplinary Work Evaluation Tool

    Problems related to the physically, environmentally and psychosocially demanding aspects of the work environment will be assessed using the Structured Multidisciplinary Work Evaluation Tool (SMET) rated on a 10-point scale (1-11). Responses will be trichotomized into scores 1-3 = "a low degree of problems," 4-7 = "a moderate degree of problems," and 8-10 = "a high degree of problems."

    Measured: Baseline, 6 week, 6 month

  8. Stress

    Perceived stress will be assessed using a single-item question: "Have you felt stressed recently?" (1 = not at all; 5 = very much)

    Measured: Baseline, 6 week, 6 month

  9. Perceived exertion

    Perceived physical exertion at work will be assessed using the Borg Category Ratio Scale (0 = no exertion at all; 10 = extremely strong or maximal exertion) (CR-10) and will also be applied in relation to patient transfers, as reported in previous research

    Measured: Baseline, 6 week, 6 month

  10. Patient transfers

    The number of patient transfers performed during a typical working day will be assessed using the Number of Daily Patient Transfers measure (higher values = more patient transfers performed per day, with no fixed highest value)

    Measured: Baseline, 6 week, 6 month

  11. Productivity

    Experiences of work environment-related problems that have affected health, work performance, or sickness presence (presenteeism) during the preceding seven days will be assessed on a 0-10 scale (higher scores indicate greater negative impact).

    Measured: Baseline, 6 week, 6 month

  12. Psychosocial safety climate

    Psychosocial safety climate will be assessed using the four-item Psychosocial Safety Climate Scale (4-20 scale, higher categories indicating higher level of safety climate).

    Measured: Baseline, 6 week, 6 month

  13. Physical activity

    Two questions concerning physical activity (1 = 0 minutes to 6 > 300 minutes) and exercise (1 = 0 minutes to 6 > 120 minutes) will be used, with higher categories indicating a higher level of physical activity.

    Measured: Baseline, 6 week, 6 month

  14. Need for recovery

    The need for recovery will be measured using the short version of the Need for Recovery Scale, consisting of three items (0-3 scale, higher scores indicate a greater need for recovery).

    Measured: Baseline, 6 week, 6 month

  15. Patient-Specific Functional Scale

    Participants will identify work-related activities that they find difficult to perform and rate the importance of these activities at baseline, six weeks and six months follow-up using the Patient-Specific Functional Scale (PSFS) (0 = unable to perform the activity at all; 10 = able to perform)

    Measured: Baseline, 6 week, 6 month

  16. Expectations and goal setting

    During the assessment, participants will be asked to rate their expectations regarding participation in the study, particularly in relation to increasing their knowledge of OSH, ergonomics and PHM competence. Participants will also formulate individual goals, describing what they wish to achieve through participation and identifying factors that may facilitate or hinder goal attainment.

    Measured: Baseline, 6 week, 6 month

  17. Pain intensity last week

    Description: Pain intensity: Overall work-related musculoskeletal disorders pain intensity in the back/neck/shoulder area during the last week will be measured using the Numeric Rating Scale (NRS 0-10, higher levels indicate more severe pain). One score only for the whole area.

    Time Frame: Baseline, 6-week, 6-month

    Measured: Baseline, 6 week, 6 month

  18. Neck pain intensity

    Current neck pain intensity on the NRS Scale (NRS 0-10, higher levels indicate more severe pain).

    Measured: Baseline, 6 week, 6 month

  19. Current low back pain intensity

    Current low back pain intensity (NRS 0-10, higher levels indicate more severe pain).

    Measured: Baseline, 6 week, 6 month

  20. Current shoulder pain intensity

    Current shoulder pain intensity (NRS 0-10, higher levels indicate more severe pain).

    Measured: Baseline, 6 week, 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2026
  2. Study start18 Jan 2027 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (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
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07805629
Sponsor's protocol ID
Linkoeping U
Acronym
HUMLA
Status last verified
Sep 2026
First submitted
27 Aug 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: De-identified data may be made available from the PI on reasonable request, subject to ethical and legal restrictions.

Publications

  • Lind CM. A Rapid Review on the Effectiveness and Use of Wearable Biofeedback Motion Capture Systems in Ergonomics to Mitigate Adverse Postures and Movements of the Upper Body. Sensors (Basel). 2024 May 23;24(11):3345. doi: 10.3390/s24113345.

    PubMed 38894134
  • Kugler HL, Taylor NF, Brusco NK. Patient handling training interventions and musculoskeletal injuries in healthcare workers: Systematic review and meta-analysis. Heliyon. 2024 Jan 26;10(3):e24937. doi: 10.1016/j.heliyon.2024.e24937. eCollection 2024 Feb 15.

    PubMed 38371982
  • Wahlin C, Stigmar K, Nilsing Strid E. A systematic review of work interventions to promote safe patient handling and movement in the healthcare sector. Int J Occup Saf Ergon. 2022 Dec;28(4):2520-2532. doi: 10.1080/10803548.2021.2007660. Epub 2021 Dec 19.

    PubMed 34789085
  • Lu L, Ko YM, Chen HY, Chueh JW, Chen PY, Cooper CL. Patient Safety and Staff Well-Being: Organizational Culture as a Resource. Int J Environ Res Public Health. 2022 Mar 21;19(6):3722. doi: 10.3390/ijerph19063722.

    PubMed 35329410
  • Carayon P, Wetterneck TB, Rivera-Rodriguez AJ, Hundt AS, Hoonakker P, Holden R, Gurses AP. Human factors systems approach to healthcare quality and patient safety. Appl Ergon. 2014 Jan;45(1):14-25. doi: 10.1016/j.apergo.2013.04.023. Epub 2013 Jul 8.

    PubMed 23845724
  • Agency for Work Environment Expertise. Safe patient handling - A research based guide for a better working environment.; 2022 Swedish Report No.: 978-91-987762-7-0. 2024 English report No.:978-91-89747-61-6.

Questions about this trial

What is this clinical trial studying?

A study testing Group A. Patient handling and movement training and Group B: Patient handling and movement training plus biofeedback in people with Work-Related Musculoskeletal Disorders, run by Linkoeping University.

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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact Anneli Peolsson, Professor, PhD (+4613284601, anneli.peolsson@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain intensity (time frame: Baseline, 6-week, 6-month). The study lists 2 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 NCT07805629, 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 10 Sep 2026.

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