Clinical trial NCT05447858: Systematic Work Environment Model Incorporating Web-based Neck-specific Exercise for Dental Staff With Neck Pain
Official title: Systematic Work Environment Model Incorporating Web-based Neck-specific Exercise for Dental Staff With Neck Pain: A Prospective Randomized Controlled Study (WorkCIT)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Workplace
Neck Pain
Exercise
Keywords: Neck pain
Workplace
Counseling
Exercise
Internet
Cervical spine
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Ostergotland County Council, Sweden
name: Lund University
name: Karlstad University
name: The University of Queensland
name: Sormland County Council, Sweden
First posted: 2022-07-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

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
* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Current neck pain intensity
timeFrame: 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:
measure: Work Ability Index (WAI) including Work Ability Scale (question no 1 in WAI)
timeFrame: Change in work ability from baseline to 3 month and 15 month follow-up
measure: Intensity of pain and bothersomeness
timeFrame: Change from baseline to 3 month and 15 month follow-up
measure: Frequency of pain, symptoms and medications
timeFrame: Change from baseline to 3 month and 15 month follow-up
measure: Neck specific function
timeFrame: Change from baseline to 3 month and 15 month follow-up
measure: Symptom satisfaction
timeFrame: Change from baseline to 3 month and 15 month follow-up
measure: Exercise/ Physical activity level
timeFrame: Change from baseline to 3 month and 15 month follow-up
measure: Health related quality of life, EQ-5D-5L
timeFrame: Change from baseline to 3 month and 15 month follow-up
measure: Perceived exertion at work
timeFrame: Change from baseline to 3 month and 15 month follow-up
measure: Sick-leave
timeFrame: Change from baseline to 3 month and 15 month follow-up
measure: Effort-Reward Imbalance
timeFrame: Change from baseline to 3 month and 15 month follow-up
measure: Risk identification at work
timeFrame: Change from baseline to 3 month and 15 month follow-up
measure: Work adaptation
timeFrame: Change from baseline to 3 month and 15 month follow-up
measure: Time sitting
timeFrame: Change from baseline to 3 month and 15 month follow-up
measure: Anxiety and depression
timeFrame: Change from baseline to 3 month and 15 month follow-up
measure: Fullfilment of treatment expectation
timeFrame: Change from baseline to 3 month and 15 month follow-up
measure: Overall outcome
timeFrame: Cross-sectional 3 month and 15 month follow-up
measure: Satisfaction with the caregiver visits in the study
timeFrame: Cross-sectional 3 month and 15 month follow-up
measure: Cost-effectiveness. (Will be analysed in a later stage if differences appear between groups)
timeFrame: From the time period between baseline to 15 month follow-up
measure: Saliva samples and blood samples (Sub-group, not in the RCT)
timeFrame: Change from baseline to 3-month follow-up in the subgroup of the RCT population
measure: Microdialysis, tissue changes in the middle of Trapezius (Subgroup study, not in the RCT)
timeFrame: Change from baseline to 3 month, subgroup of the RCT population
measure: Interview study of employees (Sub-group study, not in the RCT)
timeFrame: after intervention fulfilled, sub-group of the RCT population, n=approximately 15
measure: Interview with managers (Subgroup study)
timeFrame: After having at least one employee participating and fulfilled the study.
measure: Perceived work environment problems
timeFrame: Description and change from baseline to 3 month and 15 month follow-up
measure: Work environment related production loss
timeFrame: Description and change from baseline to 3 month and 15 month follow-up
measure: Self-rated work situation regarding neck position at work
timeFrame: Description and change from baseline to 3 month and 15 month follow-up
measure: Health related quality of life, EQ thermometer
timeFrame: Change from baseline to 3 and 15 months
Other outcomes:
measure: Profession
timeFrame: Baseline
measure: Background data
timeFrame: Baseline
measure: Treatment outside the study
timeFrame: Descripton baseline, 3 month, 15 month
measure: Profession
timeFrame: Description baseline, 3 month and 15 month
measure: work situation
timeFrame: Descriptive data at baseline, 3 month and 15 month follow-up
Locations:
Study officials:
affiliation: Linkoeping University
name: Anneli Peolsson, Prof., PhD
role: PRINCIPAL_INVESTIGATOR
References: