Convergence Dialogue Meeting With or Without Neck-specific Exercise Promoting Work Ability

Study Overview
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Brief Summary
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The study will be conducted at workplaces, where the work environment and tasks increase employee risk of developing neck problems. A total of 320 participants will be recruited consecutively and after informed consent randomized to convergenge dialogue meeting with or without neck-specific exercise. The main outcome measure is work ability, measured via the Work Ability Score.

Detailed Description
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Background: Collaboration between employees, manager and occupational health expert is needed to promote work ability. One effective method is a convergence dialogue meeting (CDM). Based on the existing work situation, factors are identified in these meetings that can strengthen the employee's work ability and opportunities for a sustainable working life. A combination of workplace and individual interventions is recommended for best effect. Neck-specific exercise (NSE) is the method with the most evidence for neck problems. NSE in evidence based form has not been investigated for work-related neck pain. More knowledge is needed regarding how CDM can be combined with NSE because clear guidelines are lacking on the best intervention for increased work ability in the case of neck problems. Also lacking are evaluations of digitally distributed CDMs and NSE with support from a web-based program for the current population. The aim of the proposed randomized controlled study is to investigate the contribution of NSE with four visits to a physiotherapist and support from a web-program in addition to three digital CDMs promoting the work situation. Methods: The study will be conducted at workplaces, where the work environment and tasks increase employee risk of developing neck problems. A total of 320 participants will be recruited consecutively and after informed consent randomized to CDM with or without NSE. The main outcome measure is work ability, measured via the Work Ability Score. Secondary outcome measures are pain, function, health-related quality of life, work absenteeism and presenteeism, work-related factors, and cost-effectiveness. Pathophysiological aspects regarding inflammation and stress markers measured in blood and saliva will be studied, as will muscular changes measured by microdialysis. Interviews are planned with both employees and managers. Discussion: The goal of the study is to contribute to improved rehabilitation, strengthened work ability, and a sustainable working life for employees with neck problems.

Official Title
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What Does Web-based Neck-specific Exercise Add to a Digital Convergence Dialogue Meeting Promoting the Work Situation for Employees With Neck Pain?

Conditions
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Workplace

Intervention / Treatment
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* Other: convergence dialogue meeting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-reported neck problems that the person experiences as troublesome, affecting ability to perform work, and lasting at least 4 weeks. Neck problems as being predominant. Current neck pain ≥ 3 on the numeric rating scale (0-10) [53, 55]. Persons of working age, 18-65 years, who have a permanent job. Neck problems clinically verified through a clinical examination to ensure study criteria are met. Answers the baseline questionnaire and attends the first intervention visit. Confirms being motivated to participate and completes and signs informed consent, including approval, to contact their immediate supervisor regarding a CDM. Exclusion Criteria: Red flags and illness/injury that are contraindicated for or hinder exercise or may be confounding factors for the results, such as severe cardiovascular/lung disease, malignancy, severe rheumatic disease, severe neurological disease, spinal cord injury, diagnosed severe mental illness, drug or alcohol abuse, neck surgery, neck fracture or dislocation, severe cervical radiculopathy, myelopathy, general body pain (e.g., fibromyalgia, Ehlers-Danlos syndrome, generalized osteoarthritis). Known pregnancy. Cannot understand/communicate in Swedish and thus would be unable to understand information in the study. For blood samples (not wanting to participate does not constitute exclusion for the randomized controlled trial), the following exclusion criteria are added: increased tendency to bleed and use of blood thinners. For the subgroup for microdialysis (n = 30, consecutively asked, 15 persons/group; not wanting to participate does not constitute exclusion for the randomized controlled trial), the following exclusion criteria are added: Patients who cannot imagine refraining from non-steroid anti-inflammatory drugsduring 2 days before microdialysis may not participate in the microdialysis part of the study. Hypersensitivity to anesthetic and antibiotics. Increased tendency to bleed and use of blood-thinning drugs.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Convergence dialogue meeting<br>Digital counceling with convergence dialogue tripartite meeting. will be conducted in accordance with work dialogue for return to work. Workplace dialogue among employee with neck problems, an expert in the work environment, and the immediate manager. The purpose of the conversations is, in open dialogue, to reach a common understanding of the situation and identify possible interventions to maintain or improve the employee´s work ability. | Other: convergence dialogue meeting<br>* Digital counceling with convergence dialogue tripartite meeting. will be conducted in accordance with work dialogue for return to work. Workplace dialogue among employee with neck problems, an expert in the work environment, and the immediate manager. The purpose of the conversations is, in open dialogue, to reach a common understanding of the situation and identify possible interventions to maintain or improve the employee´s work ability.<br>|
| Experimental: Neck-specific exercise in addition to convergence dialogue meeting<br>Neck-specific exercise with digital web-based support and four visits to a physiotherapist. Neck-specific exercise will be performed based on a well-structured framework of neck-specific exercise for facilitation of deep neck muscles, increased muscle coordination, improved neck posture and increased neck muscle endurance. Plus additional convergence dialogue meeting as treatment arm no 1. | Other: convergence dialogue meeting<br>* Digital counceling with convergence dialogue tripartite meeting. will be conducted in accordance with work dialogue for return to work. Workplace dialogue among employee with neck problems, an expert in the work environment, and the immediate manager. The purpose of the conversations is, in open dialogue, to reach a common understanding of the situation and identify possible interventions to maintain or improve the employee´s work ability.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work Ability Score | Current work ability compared to when it was at its best | Change in work Ability Score from baseline, to every month until the 15 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of pain and bothersomeness | neck pain intensity and bothersomeness, headache intensity on a numeric ratin scale. | change from baseline to 3 month and 15 month follow-up | 
| Frequency of pain, symtoms and medications | Frequency of pain, pain medication, neck stiffness, numbness/tingling into the arms, having problems lifting the arms, dizziness, sleep, concentration | change from baseline to 3 month and 15 month follow-up | 
| Neck specific function | Neck Disability Index | change from baseline to 3 month and 15 month follow-up | 
| Symptom satisfaction | Symptom satisfaction according to Cherkin | change from baseline to 3 month and 15 month follow-up | 
| Exercise/physical activity level | Exercise/physical activity level | change from baseline to 3 month and 15 month follow-up | 
| Health related quality of life | EQ-5D-3L | change from baseline to 3 month and 15 month follow-up | 
| Fear avoidance | Fear avoidance beliefs questionnaire | change from baseline to 3 month and 15 month follow-up | 
| self rated function | Patient Specific Functional Scale | change from baseline to 3 month follow-up | 
| work situation | description of work tasks | description and change from baseline to 3 month and 15 month follow-up | 
| self-rated work situation regarding working hours | working hours | description and change from baseline to 3 month and 15 month follow-up | 
| perceived exertion at work | Borg ratings of perceived exertion | change from baseline to 3 month and 15 month follow-up | 
| Work ability | work ability index | change from baseline to 3 month and 15 month follow-up | 
| Sick leave, | sick leave numbers of days/ month | change from baseline to 3 month and 15 month follow-up | 
| Presenteeism | presenteeism number of days/ month and Stanford presenteeism scale | change from baseline to 3 month and 15 month follow-up | 
| Effort-Reward Imbalance | Effort Reward Imbalance questionnaire | change from baseline to 3 month and 15 month follow-up | 
| Demand-control, support | Swedish Demand Control Support Questionnaire which is a short version of the Job centent questionnaire | change from baseline to 3 month and 15 month follow-up | 
| Risk identifaction at work | Structured multidisciplinary work evaluation tool | change from baseline to 3 month and 15 month follow-up | 
| work adaptation | work adaptation such as self strategies to be able to work | change from baseline to 3 month and 15 month follow-up | 
| Time sitting | Time sitting at work and during leisure time | change from baseline to 3 month and 15 month | 
| Anxiety and depression | Hospital Anxiety and Depression scale | change from baseline to 3 month and 15 month follow-up | 
| Overall outcome | Global rating of change scale | change from baseline to follw-ups at 3 month and 15 month | 
| Fulfilment of treatment expectation | Fulfilment of treatment expectation, have your expectations been fulfilled: yes, yes partly, no | 3 month and 15 month related to the patient own expectations | 
| Satisfaction with the caregiver visits in the study | Patient enablement questionnaire | 3 month, 15 month | 
| Adverse events/ side-effects | adverese events/ side effects of treatment in the study | 3 month, 15 month | 
| Cost-effectiveness | Cost effectiveness 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. | From the time period between baseline to 15 month follow-up | 
| Saliva samples and blood samples | Inflammation markers, stress markers. The samples will be taken in the morning on an empty stomach. 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. | change from baseline to 3 month in a subgroup of the RCT population, all those who agree and are without contra indication | 
| Microdialysis, tissue changes in the middle Trapezius | 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 catheter inserted into the tissue and flushed by a fluid (perfusate) that is similar in chemical composition to the fluid in the muscle interstitium. | baseline, 3 month, subgroup of the RCT population approximately n=30 | 
| Interview study of employers | employers experience with interventions and their impact on work ability, health and work situation | 3 month, subgroup of the RCT population, n=20 approximately | 
| Interview with managers | Interviews with managers regarding the experience of the convergence dialogue meeting | 3 month, approximately n=20 | 
| Observation study | Observation study regarding the interaction between the participants in the converge dialogue meeting. Qualitative data in natural clinical settings of CDMs will be collected through video recordings (≈ 20) to find the meaning of what happen and the interactions during the dialogue. Tripartiate dialogue between patient, manager and care giver regarding the work situation and how to improve it. | During the 3 month treatment period at tripartiate convergence dialogue meeting | 
| Health related quality of life on vertical visual analogue scale | EQ thermometer | change from baseline to 3 month and 15 month follow-up | 
| self-rated work situation regarding stress at work | work stress | description and change from baseline to 3 month and 15 month follow-up | 
| self-rated work situation regarding work environment | work environment | description and change from baseline to 3 month and 15 month follow-up | 
| self-rated work situation regarding satisfaction at work | workplace and work satisfaction | description and change from baseline to 3 month and 15 month follow-up | 
| self-rated work situation regarding self-rated work performance | work performance | description and change from baseline to 3 month and 15 month follow-up | 
| self-rated work situation regarding neck position at work | neck position | description and change from baseline to 3 month and 15 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neck pain, Workplace, Counceling, Exercise, Internet-based intervention