WorkplaceWorkCITNCT05447858
Systematic Work Environment Model Incorporating Web-based Neck-specific Exercise for Dental Staff With Neck Pain
A study testing SWEA and Neck-specific exercise in people with Workplace and Neck Pain, run by Linkoeping University.
Trial summary
The aim of study; WorkCIT is to investigate whether managerial support in using systematic work environment evaluation and adjustment (SWEA) with/without additional 3 month web-based NSEs with four visits to a physiotherapist is effective in promoting reduced neck pain and disability among dental health care… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- SWEA and Neck-specific exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 9 Jan 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For employees:
- Self-reported WRNP lasting at least 4 weeks
- Current neck pain ≥ 3 on the numeric rating scale (Numeric Rating Scale (NRS), 0-10)
- Working age, 18-65 y
- Neck problems clinically verified by clinical examination to ensure study criteria are met
- Answered the baseline questionnaire and attended the first intervention visit
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- Completed and signed informed consent, including approval, to contact their immediate supervisor regarding work adaptations.
- For managers:
- Being a head/ manager of a dental clinic.
Who cannot join
- Red flags and illness/injury that are contraindicated for or hinder exercise or may be confounding factors for the results including:
- Known pregnancy
- Cannot understand/communicate in Swedish and would be unable to understand information about the study or answer questionnaires.
- For blood samples (not wanting to participate does not constitute exclusion from the RCT), the following exclusion criteria are added:
- Increased tendency to bleed and use of blood thinners.
- For the microdialysis subgroup (n=30), consecutively asked, 15 persons/group; not wanting to participate does not constitute exclusion from the RCT), the following exclusion criteria are added:
- Cannot imagine refraining from anti-inflammatory drugs (NSAIDs) during the 2 days prior to microdialysis
- Hypersensitivity
About this study
Official title: Systematic Work Environment Model Incorporating Web-based Neck-specific Exercise for Dental Staff With Neck Pain: A Prospective Randomized Controlled Study (WorkCIT)
The aim of study; WorkCIT is to investigate whether managerial support in using systematic work environment evaluation and adjustment (SWEA) with/without additional 3 month web-based NSEs with four visits to a physiotherapist is effective in promoting reduced neck pain and disability among dental health care professionals (DHCP) with work-related neck pain (WRNP).
The aim of the subgroup studies is to investigate biomarkers and tissue changes and the association with pain, work ability, and other outcomes before and after SWEA with or without NSEs. Furthermore, to investigate dental staff experiences with the interventions and their impact on work ability, health and their work situation, and investigate managers experience of SWEA with support from the Prehab guide and workshops.
Read more
The hypothesis is that a combined effort with SWEA to promote the work situation together with NSEs will reduce neck pain intensity and improve work ability to a greater extent than the SWEA only.
Methods and analysis: This is a prospective, longitudinal, randomised, controlled multi-centre trial with two parallel treatment arms and blinded investigators conducted according to a detailed protocol following the guidelines in the CONSORT checklist. A total of 240 DHCP with WRNP will be recruited. The main outcome is neck pain intensity. Secondary outcomes are work ability, function, health-related quality of life, work absenteeism, work-related factors, and work adjustments made. Cost-effectiveness will be studied from a societal perspective if significant differences appear between randomization groups regarding health-related quality of life and will in that case be reported in a separate paper. To improve diagnostics and help assess the effectiveness of intervention biochemical sub-group studies will be performed before and after intervention to investigate pain related biomarkers. Interviews with a sub-group of participants and managers will be performed regarding work-ability, work adjustments and experiences of interventions.
Read the detailed description
Introduction: Neck pain among dental health care professionals (DHCP) is a growing societal problem. It is compulsory by law, for managers to work with systematic work environment evaluation and adjustment (SWEA), though managers knowledge of this approach is often deficient. Managerial support in using SWEA to enhance employees' work situation has not been investigated in regards to work-related neck pain (WRNP). Clear guidelines on interventions for WRNP are lacking. Neck-specific exercise (NSE) is the method with the most evidence regarding treatment for neck problems in general but has not been investigated for WRNP. The aim of study; WORKCIT is to investigate whether managerial support in using SWEA with/without additional 3 month web-based NSEs with four visits to a physiotherapist is effective in promoting reduced neck pain and disability among DHCP with WRNP. More specifically, the main project aims to: Compare the effects of SWEA with a focus on adjustments at work and support for DHCP (aimed for all staff) by their manager with the addition (half of the staff) of an E-health solution of NSEs in combination with four visits to a physiotherapist with regards to neck pain intensity, disability, work ability, health, and cost-effectiveness; Investigate whether a participatory approach of workshops and digital education for managers in SWEA/ Prehabguiden Suntarbetsliv (Prehab guide) enhance the work environment (organisational, social, and physical), including individual support and adjustment of the work situation, reducing their neck pain intensity; Investigate if NSE reduces WRNP in addition to SWEA; Identify underlying factors associated with the outcome following work interventions with or without exercise regarding pain, work ability, and health.
The aim of the subgroup studies is to investigate biomarkers and tissue changes and the association with pain, work ability, and other outcomes before and after SWEA with or without NSEs. Furthermore, to investigate dental staff experiences with the interventions and their impact on work ability, health and their work situation, and investigate managers experience of SWEA with support from the Prehab guide and workshops.
The hypothesis is that a combined effort with SWEA to promote the work situation together with NSEs will reduce neck pain intensity and improve work ability to a greater extent than the SWEA only.
Methods and analysis: This is a prospective, longitudinal, randomised, controlled multi-centre trial with two parallel treatment arms and blinded investigators conducted according to a detailed protocol following the guidelines in the CONSORT checklist. A total of 240 DHCP with WRNP will be recruited. The main outcome is neck pain intensity. Secondary outcomes are work ability, function, health-related quality of life, work absenteeism, work-related factors, and work adjustments made. Cost-effectiveness will be studied from a societal perspective if significant differences appear between randomization groups regarding health-related quality of life and will in that case be reported in a separate paper. To improve diagnostics and help assess the effectiveness of intervention biochemical sub-group studies will be performed before and after intervention to investigate pain related biomarkers. Interviews with a sub-group of participants and managers will be performed regarding work-ability, work adjustments and experiences of interventions.
Ethics and dissemination: The study is approved by the Swedish Ethical Review Authority. The processing of personal data according to the General Data Protection Regulation will be registered at Linköping University before the start of the study. The results will be published in scientific journals, presented at scientific conferences and in meetings with caregivers, disseminated in lectures to the medical faculty and patient associations, and communicated in the media.
- Being tested
- SWEA, Neck-specific exercise
- Keywords
- Neck pain, Workplace, Counseling, Exercise, Internet, Cervical spine
- Medical subject headings
- Neck Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SWEAOther
Managers with one or several l staff experiencing WRNP will be educated in the Prehab guide. The manager should read and listen to all modules and a 1-h lecture recorded by the research team before participating in two workshops (4 h each), together with other managers and an experienced expert in work environmental health and rehabilitation. In the workshops, different themes will be discussed, such as physical, psychological, and organisational work-related health, prevention, and rehabilitation, how to lead problem-solving dialogue, how work-related adaptations can be performed related to WRNP, and questions about the Prehab guide. The Prehab guide will be used to deliver managerial support in the work with the Swedish Work Environment Authority's regulations regarding SWEA and the prevention of ill health, sick leave, and accidents, work adaptations, and workplace-oriented rehabilitation.
Neck-specific exerciseOther
NSEs will be performed based on a well-structured framework of evidence-based exercises for facilitation of deep neck muscles, improved interaction between the different muscle layers of the neck, increased neck muscle endurance, and improved postural control .
| Study group | Role | What they receive |
|---|---|---|
| Managerial support in using systematic work environment evaluation and adjustment (SWEA) | Active comparator | Managerial support in using SWEA and the Prehab guide to enhance employees' work situation. Individual work adaptations are adaptations to everyone´s ability in the physical, organisational, and social work environment that aim to enable an employee with reduced ability to perform the normal work, continue working, or plan for a sustainable return to work. The Prehab guide contains a self-assessment test for the employee based on the requirements of the work and one's own ability that can be used in the dialogue with the manager. It also contains suggestions for activities to create a healthier workplace, such as discovering early signals of stress or pain, creating a caring workplace culture and boundaries, regular contact with an employee that is on sick-leave, clear and established safety procedures and routines for the work environmental work, routines for cooperation with other parties, and to learn from one's own and colleague's experiences in an open, permissive climate. Receives: Other: Neck-specific exercise |
| Neck-specific exercise in addition to SWEA | Experimental | NSEs will be performed based on a well-structured framework of evidence-based exercises for facilitation of deep neck muscles, improved interaction between the different muscle layers of the neck, increased neck muscle endurance, and improved postural control [15, 30]. To ensure that the exercises are learned and performed correctly, the participant will meet with a physiotherapist a total of four times, once during weeks 2, 3, 4, and 7 (week 1=first visit for a clinical examination due to law) for instruction, guidance, and support. In addition to photos, videos, and text regarding the exercises, the digital support (web-based program at the support and treatment platform Inera via 1177 managed by the County Councils) also contains information about why it is important to exercise the neck muscles, factors that may cause neck pain, how relapses can be handled, ergonomic advice related to the neck, and an exercise diary. Receives: Other: SWEA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Current neck pain intensity
Current neck pain intensity at 15 months follow-up measured on the numeric rating scale (NRS) (0=no pain and 10=worst imaginable pain)
Measured: Change in current neck pain intensity from baseline, to 3 month (after intervention) and until the 15 month follow-up (1 year after intervention ended).
Secondary outcomes (26)
Work Ability Index (WAI) including Work Ability Scale (question no 1 in WAI)
Current work ability compared to when it was at its best, total score, between 7 and 49, poor (7-27), moderate (28-36), good (37-43) and excellent (44-49) work ability
Measured: Change in work ability from baseline to 3 month and 15 month follow-up
Intensity of pain and bothersomeness
neck pain bothersomeness, headache intensity on NRS
Measured: Change from baseline to 3 month and 15 month follow-up
Frequency of pain, symptoms and medications
Frequency of pain, pain medication, neck stiffness, numbness/tingling into the arms, having problems lifting the arms, dizziness, sleep, concentration.
Measured: Change from baseline to 3 month and 15 month follow-up
Neck specific function
Neck Disability Index, 0 to 50 points or 0 to 100%; 0= no disability
Measured: Change from baseline to 3 month and 15 month follow-up
Symptom satisfaction
Symptom satisfaction; how patients would feel about having their current (the last 24-hours) neck symptoms for the rest of thir lives, 1=delighted, 7=terrible (according to Cherkin and Deyo)
Measured: Change from baseline to 3 month and 15 month follow-up
Exercise/ Physical activity level
Exercise/ physical activity level, how much time do you spend a regular week doing physical exercise and regular physical exercise, respectively, in median minutes, more minutes= better
Measured: Change from baseline to 3 month and 15 month follow-up
Health related quality of life, EQ-5D-5L
Euroqol 5 dimension; EQ-5D-5L, The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems, a summed score of all 5 questions will be used where 1=perfect health.
Measured: Change from baseline to 3 month and 15 month follow-up
Perceived exertion at work
Borg scale of exertion, ratings of perceived exertion at work measured with the Borg scale; 0=no exertion, 10=major exertion
Measured: Change from baseline to 3 month and 15 month follow-up
Sick-leave
sick leave numbers of days/month
Measured: Change from baseline to 3 month and 15 month follow-up
Effort-Reward Imbalance
Effort-Reward Imbalance questionnaire, less than 1 is indicating a favour of rewards, more than 1 indicating a favour of effort
Measured: Change from baseline to 3 month and 15 month follow-up
Risk identification at work
Structured multidisciplinary work evaluation tool, (SMET) will be used. The questionnaire asks about physically, environmentally and psychosocially demanding work items (30 items). A scale of 1-10 is used in the questionnaire, 1 is labeled "Not at all" and 10 is labeled "Highly".
Measured: Change from baseline to 3 month and 15 month follow-up
Work adaptation
Open questions about work adaptation, such as self strategies to be able to work
Measured: Change from baseline to 3 month and 15 month follow-up
Time sitting
Time sitting at work and during leisure time
Measured: Change from baseline to 3 month and 15 month follow-up
Anxiety and depression
Hospital Anxiety and Depression Scale, 0-6= healthy, 7-10= mild to moderate, >10= (risk for/ indication of- a diagnos needs a clinical examination) anxiety or depression
Measured: Change from baseline to 3 month and 15 month follow-up
Fullfilment of treatment expectation
Fullfilment of treatment expectation, have your expectations been fullfilled, yes, yes partly, no
Measured: Change from baseline to 3 month and 15 month follow-up
Overall outcome
Global rating of change scale, -5= much worse, 0= unchanged, 5=much better/restored
Measured: Cross-sectional 3 month and 15 month follow-up
Satisfaction with the caregiver visits in the study
Patient enablement questionnaire, The PEI is a 6-item scale that has been used in general prac-tice to evaluate quality of care. The highest possible score is 12, with higher scores indicating greater enablement.
Measured: Cross-sectional 3 month and 15 month follow-up
Cost-effectiveness. (Will be analysed in a later stage if differences appear between groups)
Through calculation of direct costs; quantity and type of care (inside and outside the study also including drugs related to pain) from registers and from questionnaires, indirect costs; mainly production loss from registers and from questionnaire. Will be calculated if there is a difference between randomisation groups and will in that case be presented in a paper of its own.
Measured: From the time period between baseline to 15 month follow-up
Saliva samples and blood samples (Sub-group, not in the RCT)
Experimental sub-group study. Protein analysis to investigate differences between patients and healthy controls, biomarkers of inflammation and stress. Will be performed in a sub-group. Saliva will be collected with Salivette. Venous blood samples (10-20 ml) from the elbow fold will be collected in EDTA tubes. Identification and quantification of proteins. In a subgroup of the RCT population. Comparisons will be made with healthy controls. Permits for biobank is available.
Measured: Change from baseline to 3-month follow-up in the subgroup of the RCT population
Microdialysis, tissue changes in the middle of Trapezius (Subgroup study, not in the RCT)
Biomechanical changes interstitialli in M. Trapezius. Through microdialysis technology, it is possible to monitor biochemical changes interstitially in the tissue. The technique involves the exchange of substances via diffusion between the tissue and a diaphragmatic cateter inserted into the tissue and flushed by a fluid (perfusate) that is similar in chemical composition to the fluid in the muscle interstitium. Comparisons will be made with healthy controls.
Measured: Change from baseline to 3 month, subgroup of the RCT population
Interview study of employees (Sub-group study, not in the RCT)
Employees experience with interventions and their impact on work ability, health and work situation. Sub-group of the RCT population.
Measured: after intervention fulfilled, sub-group of the RCT population, n=approximately 15
Interview with managers (Subgroup study)
Interview with managers regarding the experience of using SWEA and the Prehabguide. A subgroup will be interviewd, Approximately n=approximately 15.
Measured: After having at least one employee participating and fulfilled the study.
Perceived work environment problems
During the past 7 days, how much did your work environment-related problemsaffect your performance at work? A scale 0 - 10 is used, 0 is labeled " Workenvironment problems have not affected my work performance" and 10 is labeled"Work environment problems completely prevented me from working". A higher score indicates a worse outcome.
Measured: Description and change from baseline to 3 month and 15 month follow-up
Work environment related production loss
During the past 7 days, how much did your work environment-related problemsaffect your performance at work? A scale 0 - 10 is used, 0 is labeled " Workenvironment problems have not affected my work performance" and 10 is labeled"Work environment problems completely prevented me from working". A higherscore indicates a worse outcome.
Measured: Description and change from baseline to 3 month and 15 month follow-up
Self-rated work situation regarding neck position at work
Numeric rating scale 0-10, 10= very satisfied
Measured: Description and change from baseline to 3 month and 15 month follow-up
Health related quality of life, EQ thermometer
Euroqol vertical visual analogue scale, 0-100, 100=perfect health
Measured: Change from baseline to 3 and 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start9 Jan 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: Lack of fundings
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WorkplaceStudies 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
- Randomization will be handled by a person not involved in intervention or evaluation. Investigators/ assessors will be blinded for randomization. This is a prospective, longitudinal, randomised, controlled multi-centre trial with two parallel treatment arms and blinded investigators conducted according to a detailed protocol. A total of 240 employees with WRNP will be recruited. The main outcome is neck pain intensity. Secondary outcomes are work ability, function, health-related quality of life, work absenteeism, work-related factors, work adjustments made. Cost-effectiveness will be studied if significant differences appear between randomization groups regarding health-related quality of life and will in that case be reported in a separate paper.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Ostergotland County Council, Sweden, Lund University, Karlstad University, The University of Queensland, Sormland County Council, Sweden
- Responsible party
- Principal investigator, Anneli Peolsson, Linkoeping University
- Investigators
- Anneli Peolsson, Prof., PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447858
- Sponsor's protocol ID
- Dnr 2022-02188-02
- Acronym
- WorkCIT
- Status last verified
- Dec 2023
- First submitted
- 28 Jun 2022
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is protected by the Swedish health secrets act and the European General Data Protection Regulation. Data will be presented on a group level without possibility for individual identification.
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Work Environment Model Incorporating Web-based Neck-specific Exercise for Dental Staff With Neck Pain: A Prospective Randomized Controlled Study (WorkCIT)
- ClinicalTrials.gov ID
- NCT05447858
- Acronym / sponsor ID
- WorkCIT / Dnr 2022-02188-02
- Keywords
- Neck pain, Workplace, Counseling, Exercise, Internet, Cervical spine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of fundings
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Ostergotland County Council, Sweden, Lund University, Karlstad University, The University of Queensland, Sormland County Council, Sweden
- Study start
- 9 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Jul 2022 (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 aim of study; WorkCIT is to investigate whether managerial support in using systematic work environment evaluation and adjustment (SWEA) with/without additional 3 month web-based NSEs with four visits to a physiotherapist is effective in promoting reduced neck pain and disability among dental health care professionals (DHCP) with work-related neck pain (WRNP).
The aim of the subgroup studies is to investigate biomarkers and tissue changes and the association with pain, work ability, and other outcomes before and after SWEA with or without NSEs. Furthermore, to investigate dental staff experiences with the interventions and their impact on work ability, health and their work situation, and investigate managers experience of SWEA with support from the Prehab guide and workshops.
The hypothesis is that a combined effort with SWEA to promote the work situation together with NSEs will reduce neck pain intensity and improve work ability to a greater extent than the SWEA only.
Methods and analysis: This is a prospective, longitudinal, randomised, controlled multi-centre trial with two parallel treatment arms and blinded investigators conducted according to a detailed protocol following the guidelines in the CONSORT checklist. A total of 240 DHCP with WRNP will be recruited. The main outcome is neck pain intensity. Secondary outcomes are work ability, function, health-related quality of life, work absenteeism, work-related factors, and work adjustments made. Cost-effectiveness will be studied from a societal perspective if significant differences appear between randomization groups regarding health-related quality of life and will in that case be reported in a separate paper. To improve diagnostics and help assess the effectiveness of intervention biochemical sub-group studies will be performed before and after intervention to investigate pain related biomarkers. Interviews with a sub-group of participants and managers will be performed regarding work-ability, work adjustments and experiences of interventions.
Detailed description
Introduction: Neck pain among dental health care professionals (DHCP) is a growing societal problem. It is compulsory by law, for managers to work with systematic work environment evaluation and adjustment (SWEA), though managers knowledge of this approach is often deficient. Managerial support in using SWEA to enhance employees' work situation has not been investigated in regards to work-related neck pain (WRNP). Clear guidelines on interventions for WRNP are lacking. Neck-specific exercise (NSE) is the method with the most evidence regarding treatment for neck problems in general but has not been investigated for WRNP. The aim of study; WORKCIT is to investigate whether managerial support in using SWEA with/without additional 3 month web-based NSEs with four visits to a physiotherapist is effective in promoting reduced neck pain and disability among DHCP with WRNP. More specifically, the main project aims to: Compare the effects of SWEA with a focus on adjustments at work and support for DHCP (aimed for all staff) by their manager with the addition (half of the staff) of an E-health solution of NSEs in combination with four visits to a physiotherapist with regards to neck pain intensity, disability, work ability, health, and cost-effectiveness; Investigate whether a participatory approach of workshops and digital education for managers in SWEA/ Prehabguiden Suntarbetsliv (Prehab guide) enhance the work environment (organisational, social, and physical), including individual support and adjustment of the work situation, reducing their neck pain intensity; Investigate if NSE reduces WRNP in addition to SWEA; Identify underlying factors associated with the outcome following work interventions with or without exercise regarding pain, work ability, and health.
The aim of the subgroup studies is to investigate biomarkers and tissue changes and the association with pain, work ability, and other outcomes before and after SWEA with or without NSEs. Furthermore, to investigate dental staff experiences with the interventions and their impact on work ability, health and their work situation, and investigate managers experience of SWEA with support from the Prehab guide and workshops.
The hypothesis is that a combined effort with SWEA to promote the work situation together with NSEs will reduce neck pain intensity and improve work ability to a greater extent than the SWEA only.
Methods and analysis: This is a prospective, longitudinal, randomised, controlled multi-centre trial with two parallel treatment arms and blinded investigators conducted according to a detailed protocol following the guidelines in the CONSORT checklist. A total of 240 DHCP with WRNP will be recruited. The main outcome is neck pain intensity. Secondary outcomes are work ability, function, health-related quality of life, work absenteeism, work-related factors, and work adjustments made. Cost-effectiveness will be studied from a societal perspective if significant differences appear between randomization groups regarding health-related quality of life and will in that case be reported in a separate paper. To improve diagnostics and help assess the effectiveness of intervention biochemical sub-group studies will be performed before and after intervention to investigate pain related biomarkers. Interviews with a sub-group of participants and managers will be performed regarding work-ability, work adjustments and experiences of interventions.
Ethics and dissemination: The study is approved by the Swedish Ethical Review Authority. The processing of personal data according to the General Data Protection Regulation will be registered at Linköping University before the start of the study. The results will be published in scientific journals, presented at scientific conferences and in meetings with caregivers, disseminated in lectures to the medical faculty and patient associations, and communicated in the media.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization will be handled by a person not involved in intervention or evaluation. Investigators/ assessors will be blinded for randomization. This is a prospective, longitudinal, randomised, controlled multi-centre trial with two parallel treatment arms and blinded investigators conducted according to a detailed protocol. A total of 240 employees with WRNP will be recruited. The main outcome is neck pain intensity. Secondary outcomes are work ability, function, health-related quality of life, work absenteeism, work-related factors, work adjustments made. Cost-effectiveness will be studied if significant differences appear between randomization groups regarding health-related quality of life and will in that case be reported in a separate paper.
| Arm | Type | Receives |
|---|---|---|
| Managerial support in using systematic work environment evaluation and adjustment (SWEA) | Active comparator | Other: Neck-specific exerciseManagerial support in using SWEA and the Prehab guide to enhance employees' work situation. Individual work adaptations are adaptations to everyone´s ability in the physical, organisational, and social work environment that aim to enable an employee with reduced ability to perform the normal work, continue working, or plan for a sustainable return to work. The Prehab guide contains a self-assessment test for the employee based on the requirements of the work and one's own ability that can be used in the dialogue with the manager. It also contains suggestions for activities to create a healthier workplace, such as discovering early signals of stress or pain, creating a caring workplace culture and boundaries, regular contact with an employee that is on sick-leave, clear and established safety procedures and routines for the work environmental work, routines for cooperation with other parties, and to learn from one's own and colleague's experiences in an open, permissive climate. |
| Neck-specific exercise in addition to SWEA | Experimental | Other: SWEANSEs will be performed based on a well-structured framework of evidence-based exercises for facilitation of deep neck muscles, improved interaction between the different muscle layers of the neck, increased neck muscle endurance, and improved postural control [15, 30]. To ensure that the exercises are learned and performed correctly, the participant will meet with a physiotherapist a total of four times, once during weeks 2, 3, 4, and 7 (week 1=first visit for a clinical examination due to law) for instruction, guidance, and support. In addition to photos, videos, and text regarding the exercises, the digital support (web-based program at the support and treatment platform Inera via 1177 managed by the County Councils) also contains information about why it is important to exercise the neck muscles, factors that may cause neck pain, how relapses can be handled, ergonomic advice related to the neck, and an exercise diary. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Self-reported WRNP lasting at least 4 weeks
- Current neck pain ≥ 3 on the numeric rating scale (Numeric Rating Scale (NRS), 0-10)
- Working age, 18-65 y
- Neck problems clinically verified by clinical examination to ensure study criteria are met
- Answered the baseline questionnaire and attended the first intervention visit
Key exclusion criteria (8 listed)
- Red flags and illness/injury that are contraindicated for or hinder exercise or may be confounding factors for the results including:
- Known pregnancy
- Cannot understand/communicate in Swedish and would be unable to understand information about the study or answer questionnaires.
- For blood samples (not wanting to participate does not constitute exclusion from the RCT), the following exclusion criteria are added:
- Increased tendency to bleed and use of blood thinners.
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 |
|---|---|---|
| SWEAManagers with one or several l staff experiencing WRNP will be educated in the Prehab guide. The manager should read and listen to all modules and a 1-h lecture recorded by the research team before participating in two workshops (4 h each), together with other managers and an experienced expert in work environmental health and rehabilitation. In the workshops, different themes will be discussed, such as physical, psychological, and organisational work-related health, prevention, and rehabilitation, how to lead problem-solving dialogue, how work-related adaptations can be performed related to WRNP, and questions about the Prehab guide. The Prehab guide will be used to deliver managerial support in the work with the Swedish Work Environment Authority's regulations regarding SWEA and the prevention of ill health, sick leave, and accidents, work adaptations, and workplace-oriented rehabilitation. | Other | Neck-specific exercise in addition to SWEA |
| Neck-specific exerciseNSEs will be performed based on a well-structured framework of evidence-based exercises for facilitation of deep neck muscles, improved interaction between the different muscle layers of the neck, increased neck muscle endurance, and improved postural control . | Other | Managerial support in using systematic work environment evaluation and adjustment (SWEA) |
Primary outcome
Current neck pain intensity
Time frame: Change in current neck pain intensity from baseline, to 3 month (after intervention) and until the 15 month follow-up (1 year after intervention ended).
Current neck pain intensity at 15 months follow-up measured on the numeric rating scale (NRS) (0=no pain and 10=worst imaginable pain)
26 secondary outcomes
Work Ability Index (WAI) including Work Ability Scale (question no 1 in WAI)
Time frame: Change in work ability from baseline to 3 month and 15 month follow-up
Intensity of pain and bothersomeness
Time frame: Change from baseline to 3 month and 15 month follow-up
Frequency of pain, symptoms and medications
Time frame: Change from baseline to 3 month and 15 month follow-up
Neck specific function
Time frame: Change from baseline to 3 month and 15 month follow-up
Symptom satisfaction
Time frame: Change from baseline to 3 month and 15 month follow-up
Exercise/ Physical activity level
Time frame: Change from baseline to 3 month and 15 month follow-up
Health related quality of life, EQ-5D-5L
Time frame: Change from baseline to 3 month and 15 month follow-up
Perceived exertion at work
Time frame: Change from baseline to 3 month and 15 month follow-up
Sick-leave
Time frame: Change from baseline to 3 month and 15 month follow-up
Effort-Reward Imbalance
Time frame: Change from baseline to 3 month and 15 month follow-up
Risk identification at work
Time frame: Change from baseline to 3 month and 15 month follow-up
Work adaptation
Time frame: Change from baseline to 3 month and 15 month follow-up
Time sitting
Time frame: Change from baseline to 3 month and 15 month follow-up
Anxiety and depression
Time frame: Change from baseline to 3 month and 15 month follow-up
Fullfilment of treatment expectation
Time frame: Change from baseline to 3 month and 15 month follow-up
Overall outcome
Time frame: Cross-sectional 3 month and 15 month follow-up
Satisfaction with the caregiver visits in the study
Time frame: Cross-sectional 3 month and 15 month follow-up
Cost-effectiveness. (Will be analysed in a later stage if differences appear between groups)
Time frame: From the time period between baseline to 15 month follow-up
Saliva samples and blood samples (Sub-group, not in the RCT)
Time frame: Change from baseline to 3-month follow-up in the subgroup of the RCT population
Microdialysis, tissue changes in the middle of Trapezius (Subgroup study, not in the RCT)
Time frame: Change from baseline to 3 month, subgroup of the RCT population
Interview study of employees (Sub-group study, not in the RCT)
Time frame: after intervention fulfilled, sub-group of the RCT population, n=approximately 15
Interview with managers (Subgroup study)
Time frame: After having at least one employee participating and fulfilled the study.
Perceived work environment problems
Time frame: Description and change from baseline to 3 month and 15 month follow-up
Work environment related production loss
Time frame: Description and change from baseline to 3 month and 15 month follow-up
Self-rated work situation regarding neck position at work
Time frame: Description and change from baseline to 3 month and 15 month follow-up
Health related quality of life, EQ thermometer
Time frame: Change from baseline to 3 and 15 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Individual participant dataSharing planned: No. The data is protected by the Swedish health secrets act and the European General Data Protection Regulation. Data will be presented on a group level without possibility for individual identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anneli Peolsson, Prof., PhD principal investigator
Linkoeping University
Questions about this trial
What is this clinical trial studying?
A study testing SWEA and Neck-specific exercise in people with Workplace and Neck Pain, 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 9 inclusion and 8 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: withdrawn, as of the sponsor's last update on 14 Dec 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Current neck pain intensity (time frame: Change in current neck pain intensity from baseline, to 3 month (after intervention) and until the 15 month follow-up (1 year after intervention ended).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2023.