An interventional study of Group A. Patient handling and movement training and Group B: Patient handling and movement training plus biofeedback in Work-Related Musculoskeletal Disorders, sponsored by Linkoeping University. Not yet recruiting. Open to female participants. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Linkoeping University · Not applicable, Interventional, and Treatment
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.
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.
752 studies on the registry are indexed under Musculoskeletal Diseases; 164 are open to participants now.
This study's planned enrollment of 60 is below the median of 76 across 518 interventional studies indexed under Musculoskeletal Diseases.
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Exclusion Criteria:
Participants 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.
Other: Group A. Patient handling and movement training
Group 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.
Other: Group B: Patient handling and movement training plus biofeedback
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.
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.
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.
Time frame: Baseline, 6-week, 6-month
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)."
Time frame: During the intervention period, every week from baseline to six months follow-up.
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.
Time frame: Baseline, 6 week, 6 month
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.)
Time frame: Baseline, 6 weeks, 6 month
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).
Time frame: Baseline, 6 week, 6 month
QuickDASH-7
Upper limb function will be assessed using the modified QuickDASH-7 (0 = no disability; 100 = most severe disability)
Time frame: Baseline, 6 week, 6 month
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).
Time frame: Baseline, 6 week, 6 month
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).
Time frame: Baseline, 6 week, 6 month
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."
Time frame: Baseline, 6 week, 6 month
Stress
Perceived stress will be assessed using a single-item question: "Have you felt stressed recently?" (1 = not at all; 5 = very much)
Time frame: Baseline, 6 week, 6 month
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
Time frame: Baseline, 6 week, 6 month
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)
Time frame: Baseline, 6 week, 6 month
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).
Time frame: Baseline, 6 week, 6 month
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).
Time frame: Baseline, 6 week, 6 month
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.
Time frame: Baseline, 6 week, 6 month
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).
Time frame: Baseline, 6 week, 6 month
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)
Time frame: Baseline, 6 week, 6 month
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.
Time frame: Baseline, 6 week, 6 month
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
Time frame: Baseline, 6 week, 6 month
Neck pain intensity
Current neck pain intensity on the NRS Scale (NRS 0-10, higher levels indicate more severe pain).
Time frame: Baseline, 6 week, 6 month
Current low back pain intensity
Current low back pain intensity (NRS 0-10, higher levels indicate more severe pain).
Time frame: Baseline, 6 week, 6 month
Current shoulder pain intensity
Current shoulder pain intensity (NRS 0-10, higher levels indicate more severe pain).
Time frame: Baseline, 6 week, 6 month
Background data, age
Year of birth (open-ended response)
Time frame: Baseline, 6 week, 6 month
Implementation outcome, IAM
Implementation outcomes will be assessed at 6-week and 6-month follow-up using Acceptability of Intervention Measure (AIM). The questionnaire comprise four items, answered on 5-point Likert-type scales: (1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree
Time frame: 6 week, 6 month
Evaluation of biofeedback training
Evaluation of biofeedback training (Group B only) at 6-week and 6-month follow-up: Participants will complete two six-item questionnaires on vibrotactile biofeedback. The first assesses usefulness, comfort and motivation, based on the Intrinsic Motivation Inventory, and whether repeated use improves interpretation of vibration signals and work technique. Scores are reported as mean values (1-7) or summed scores (6-43), with higher scores indicating more positive experiences.
Time frame: 6 week, 6 month
Background data from the unit manager, number of employees
At baseline unit managers provide information on the healthcare service unit in which the participating AN is employed, including the number of employees
Time frame: Baseline
Interviews with AN
Interviews with AN: To explore participants' experiences of the intervention at the six-week follow-up, semi-structured individual interviews (preferable physical meeting) will be conducted with a sample from both Group A and Group B (n ≈ 15). The interviews will explore participants' experiences of work tasks, the working conditions and safety culture in relation to nursing care and safe PHM. They will address perceived challenges, support from colleagues and managers, staff and patient safety during transfers, access to assistive devices, and experiences of implementing new work practices. The interviews will also examine participants' perceptions of the theoretical and practical training, the usefulness of the intervention in daily work, the role of biofeedback where applicable, and opportunities for sustaining and extending safe PHM practices within the workplace or organisation.
Time frame: 6 week
Interviews with managers
Interviews with managers: Following completion of the intervention at the six-week follow-up, semi-structured interviews will be conducted with a purposive sample of managers whose AN participated in the study, with the aim of exploring their experiences of the project. Approximately 10 managers will be recruited. The manager interviews will explore managers' experiences of organisational conditions for safe PHM, including their role in systematic OSH management, safety culture, risk assessment, staff and patient safety, access to assistive devices, and organisational support. The interviews will also address managers' perceptions of the intervention, its implementation in daily nursing care, the use of biofeedback where applicable, and opportunities for sustaining and scaling safe PHM practices within the workplace or organisation.
Time frame: 6 week
ICD-10
Diagnostic classification will be performed according to ICD-10 criteria, based on the clinical interview and functional assessment. A physiotherapist will conduct a clinical interview regarding AN's musculoskeletal symptoms affecting the neck/shoulder region and/or back in relation to their occupational activities. Clinical functional assessment at baseline (Week 1) will include screening of mobility and musculoskeletal function using the methodology "Medical Surveillance for Ergonomically Demanding Work (MEBA)".
Time frame: Baseline
Screening for psychosoicial risk-factors associated with pain
Screening for psychosocial risk factors associated with the development of persistent pain and long-term disability will be performed using the Örebro Musculoskeletal Pain Questionnaire
Time frame: Baseline
Technical evaluation of biofeedback training (Group B only)
Training frequency and duration will be documented in a training diary. A technical evaluation will be conducted to enable pre-post comparisons at baseline and 6-weeks follow-up. Assessments will be performed during three standardised and commonly occurring work tasks: bed making with the patient in bed, repositioning a patient higher up in bed, and transferring a patient from bed to a wheelchair. The evaluation will be based on the distribution of body segment angles, angular velocities, and the amount of vibration feedback received during task performance.
Time frame: Baseline and 6 week
Background data, duration of employement
Duration of employment (0-2 years, 2-5 years, 5-10 years, \>10 years)
Time frame: baseline, 6 week, 6 month
Background data, employement status
Full-time/part-time employment status (%).
Time frame: Baseline, 6 week, 6 month
Implementation outcome, IAM
Implementation outcome will be assessed at 6-week and 6-month follow-up using Intervention Appropriateness Measure (IAM). The questionnaire comprise four items, answered on 5-point Likert-type scales: (1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree
Time frame: 6 week, 6 month
Implementation outcome, FIM
Implementation outcome will be assessed using Feasibility of Intervention Measure (FIM). The questionnaire comprise four items, answered on 5-point Likert-type scales: (1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree
Time frame: 6 week, 6 month
Unit manager, age distribution of employees
At baseline unit managers provide information on the healthcare service unit in which the participating AN is employed, including the age distribution
Time frame: Baseline
Unit manager, gender distrbution of employees
At baseline unit managers provide information on the healthcare service unit in which the participating AN is employed including gender distribution
Time frame: Baseline
Unit manager, current sickness absence of employees
At baseline unit managers provide information on the healthcare service unit in which the participating AN is employed, including the current sickness absence rates
Time frame: Baseline
Unit manager, patient groups cared for
At baseline unit managers provide information on the healthcare service unit in which the participating AN is employed, including the patient groups cared for.
Time frame: Baseline
Unit manager, availability of work equipment
At baseline unit managers provide information on the healthcare service unit in which the participating AN is employed, including the availability of work equipment.
Time frame: Baseline
Continued training using biofeedback , group B only
Comfort, technology acceptance and motivation for continued training will be rated on a seven-point Likert scale, with higher scores indicating more positive experiences.
Time frame: 6 week
Evaluation of e-learning, open question
What conditions do you consider existing at your workplace for applying the knowledge gained from the training? (facilitating and barriers).
Time frame: Will be completed immediately after participants have undertaken the theoretical e-learning module, at latest after 6 week
E-learning
My prior knowledge was sufficient to enable me to benefit from the training (1=to a very small extent, 5= to a very large extent)
Time frame: Immediately after participants have undertaken the theoretical e-learning modulel, at latest after 6-week
E-learning
During the training, I acquired valuable knowledge (1=to a very small extent, 5= to a very large extent)
Time frame: immediately after participants have undertaken the theoretical e-learning module, at latest after 6 week
E-learning
The duration of the training was appropriate, in terms of the number of minutes (1=to a very small extent, 5= to a very large extent)
Time frame: will be completed immediately after participants have undertaken the theoretical e-learning module, at latest after 6-week
E-learning
I will be able to apply what I have learned in my work (1=to a very small extent, 5= to a very large extent)
Time frame: ill be completed immediately after participants have undertaken the theoretical e-learning module, at latest after 6 week
E-learning
The content was relevant to my work (1=to a very small extent, 5= to a very large extent)
Time frame: will be completed immediately after participants have undertaken the theoretical e-learning module, at latest after 6-week
E-learning
The training was of high quality (1=to a very small extent, 5= to a very large extent)
Time frame: will be completed immediately after participants have undertaken the theoretical e-learning module, as latest after 6 week
E-learning
I would recommend the training to others (1=to a very small extent, 5= to a very large extent)
Time frame: Will be completed immediately after participants have undertaken the theoretical e-learning module, at latest after 6 week
E-learning, open question
Did you miss any component during the training? If yes, please specify
Time frame: Will be completed immediately after participants have undertaken the theoretical e-learning module, at latest after 6 week
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Plan to share: Undecided — De-identified data may be made available from the PI on reasonable request, subject to ethical and legal restrictions.
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