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

NCT05447858 | Withdrawn DMC

• 1 other identifier: Dnr 2022-02188-02
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Workplace; Neck Pain; Exercise

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

  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)

  Change in work ability from baseline to 3 month and 15 month follow-up

• Intensity of pain and bothersomeness

  Change from baseline to 3 month and 15 month follow-up

• Frequency of pain, symptoms and medications

  Change from baseline to 3 month and 15 month follow-up

• Neck specific function

  Change from baseline to 3 month and 15 month follow-up

• Symptom satisfaction

  Change from baseline to 3 month and 15 month follow-up

Other Outcomes (5)

• Profession

  Baseline

• Background data

  Baseline

• Treatment outside the study

  Descripton baseline, 3 month, 15 month

Study Arms (2)

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.

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.

Other: SWEA

Interventions

SWEA 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.

Neck-specific exercise in addition to SWEA

Neck-specific exercise 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 .

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Linkoeping University: lead
• Ostergotland County Council, Sweden: collaborator
• Lund University: collaborator
• Karlstad University: collaborator
• The University of Queensland: collaborator
• Sormland County Council, Sweden: collaborator

MeSH Terms

Conditions

Neck Pain; Motor Activity

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Anneli Peolsson, Prof., PhD

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double (Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 7, 2022
• Study Start: January 9, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share