Systematic Work Environment Model Incorporating Web-based Neck-specific Exercise for Dental Staff With Neck Pain

NCT ID: NCT05447858

Last Updated: 2023-12-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2025-12-31

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.

Conditions

Workplace; Neck Pain; Exercise

Keywords

Neck pain; Workplace; Counseling; Exercise; Internet; Cervical spine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Managerial support in using systematic work environment evaluation and adjustment (SWEA)

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.

Group Type: ACTIVE_COMPARATOR

Neck-specific exercise

Intervention Type: OTHER

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 .

Neck-specific exercise in addition to SWEA

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.

Group Type: EXPERIMENTAL

SWEA

Intervention Type: OTHER

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.

Interventions

SWEA

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.

Intervention Type: OTHER

Neck-specific exercise

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 .

Intervention Type: OTHER

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.

• Increased tendency to bleed and use of blood thinners.

• Cannot imagine refraining from anti-inflammatory drugs (NSAIDs) during the 2 days prior to microdialysis
• Hypersensitivity

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ostergotland County Council, Sweden

OTHER

Sponsor Role: collaborator

Lund University

OTHER

Sponsor Role: collaborator

Karlstad University

OTHER

Sponsor Role: collaborator

The University of Queensland

OTHER

Sponsor Role: collaborator

Sormland County Council, Sweden

OTHER

Sponsor Role: collaborator

Linkoeping University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Anneli Peolsson

Professor, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anneli Peolsson, Prof., PhD

Role: PRINCIPAL_INVESTIGATOR

Linkoeping University

Other Identifiers

Dnr 2022-02188-02

Identifier Type: -

Identifier Source: org_study_id