An interventional study of convergence dialogue meeting in Workplace, sponsored by Linkoeping University. Withdrawn at 2 sites in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-07-11.
Sponsored by Linkoeping University · Not applicable, Interventional, and Treatment
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.
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.
Linkoeping University is the lead sponsor of 189 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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:
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
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
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.
Work Ability Score
Current work ability compared to when it was at its best
Time frame: Change in work Ability Score from baseline, to every month until the 15 month follow-up
Intensity of pain and bothersomeness
neck pain intensity and bothersomeness, headache intensity on a numeric ratin scale.
Time frame: 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
Time frame: change from baseline to 3 month and 15 month follow-up
Neck specific function
Neck Disability Index
Time frame: change from baseline to 3 month and 15 month follow-up
Symptom satisfaction
Symptom satisfaction according to Cherkin
Time frame: change from baseline to 3 month and 15 month follow-up
Exercise/physical activity level
Exercise/physical activity level
Time frame: change from baseline to 3 month and 15 month follow-up
Health related quality of life
EQ-5D-3L
Time frame: change from baseline to 3 month and 15 month follow-up
Fear avoidance
Fear avoidance beliefs questionnaire
Time frame: change from baseline to 3 month and 15 month follow-up
self rated function
Patient Specific Functional Scale
Time frame: change from baseline to 3 month follow-up
work situation
description of work tasks
Time frame: description and change from baseline to 3 month and 15 month follow-up
self-rated work situation regarding working hours
working hours
Time frame: description and change from baseline to 3 month and 15 month follow-up
perceived exertion at work
Borg ratings of perceived exertion
Time frame: change from baseline to 3 month and 15 month follow-up
Work ability
work ability index
Time frame: change from baseline to 3 month and 15 month follow-up
Sick leave,
sick leave numbers of days/ month
Time frame: change from baseline to 3 month and 15 month follow-up
Presenteeism
presenteeism number of days/ month and Stanford presenteeism scale
Time frame: change from baseline to 3 month and 15 month follow-up
Effort-Reward Imbalance
Effort Reward Imbalance questionnaire
Time frame: 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
Time frame: change from baseline to 3 month and 15 month follow-up
Risk identifaction at work
Structured multidisciplinary work evaluation tool
Time frame: change from baseline to 3 month and 15 month follow-up
work adaptation
work adaptation such as self strategies to be able to work
Time frame: change from baseline to 3 month and 15 month follow-up
Time sitting
Time sitting at work and during leisure time
Time frame: change from baseline to 3 month and 15 month
Anxiety and depression
Hospital Anxiety and Depression scale
Time frame: change from baseline to 3 month and 15 month follow-up
Overall outcome
Global rating of change scale
Time frame: 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
Time frame: 3 month and 15 month related to the patient own expectations
Satisfaction with the caregiver visits in the study
Patient enablement questionnaire
Time frame: 3 month, 15 month
Adverse events/ side-effects
adverese events/ side effects of treatment in the study
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 3 month, subgroup of the RCT population, n=20 approximately
Interview with managers
Interviews with managers regarding the experience of the convergence dialogue meeting
Time frame: 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.
Time frame: During the 3 month treatment period at tripartiate convergence dialogue meeting
Health related quality of life on vertical visual analogue scale
EQ thermometer
Time frame: change from baseline to 3 month and 15 month follow-up
self-rated work situation regarding stress at work
work stress
Time frame: description and change from baseline to 3 month and 15 month follow-up
self-rated work situation regarding work environment
work environment
Time frame: 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
Time frame: description and change from baseline to 3 month and 15 month follow-up
self-rated work situation regarding self-rated work performance
work performance
Time frame: description and change from baseline to 3 month and 15 month follow-up
self-rated work situation regarding neck position at work
neck position
Time frame: description and change from baseline to 3 month and 15 month follow-up
profession
Swedish standard for work classification
Time frame: baseline
Background data
Age, gender, education, family situation, pain duration, expectations, smoking history
Time frame: baseline
ICD 10 code
ICD 10 code decided after a physical examination
Time frame: baseline
Pain screening
Örebro musculoskeletal pain screeing questionnaire
Time frame: baseline
screening for "yellow flags"- behaviour factors at risk
START neck screening tool
Time frame: baseline
Treatment outside the study
treatment outside the study
Time frame: 3 month, 15 month
profession, open question
open question regarding profession
Time frame: description and change from baseline, 3 month and 15 month follow-up
Plan to share: No — The data is protected by the Swedish health secrets acts and the European General Data Protection Regulation. Data will be presented on a group level without possibility for individual identification.
No publications or documents are linked to this record.
This study is withdrawn, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Linkoeping University