Back to resultsConvergence Dialogue Meeting With or Without Neck-specific Exercise Promoting Work Ability (WORKCIT)
Primary Purpose
Workplace
Status
Withdrawn
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
convergence dialogue meeting
Sponsored by
About this trial
This is an interventional treatment trial for Workplace focused on measuring Neck pain, Workplace, Counceling, Exercise, Internet-based intervention
Eligibility Criteria
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.
Sites / Locations
- Anneli Peolsson
- Dep. Medical and Health Sciences, Physiotherapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Convergence dialogue meeting
Neck-specific exercise in addition to convergence dialogue meeting
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Work Ability Score
Current work ability compared to when it was at its best
Secondary Outcome Measures
Intensity of pain and bothersomeness
neck pain intensity and bothersomeness, headache intensity on a numeric ratin scale.
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
Neck specific function
Neck Disability Index
Symptom satisfaction
Symptom satisfaction according to Cherkin
Exercise/physical activity level
Exercise/physical activity level
Health related quality of life
EQ-5D-3L
Fear avoidance
Fear avoidance beliefs questionnaire
self rated function
Patient Specific Functional Scale
work situation
description of work tasks
self-rated work situation regarding working hours
working hours
perceived exertion at work
Borg ratings of perceived exertion
Work ability
work ability index
Sick leave,
sick leave numbers of days/ month
Presenteeism
presenteeism number of days/ month and Stanford presenteeism scale
Effort-Reward Imbalance
Effort Reward Imbalance questionnaire
Demand-control, support
Swedish Demand Control Support Questionnaire which is a short version of the Job centent questionnaire
Risk identifaction at work
Structured multidisciplinary work evaluation tool
work adaptation
work adaptation such as self strategies to be able to work
Time sitting
Time sitting at work and during leisure time
Anxiety and depression
Hospital Anxiety and Depression scale
Overall outcome
Global rating of change scale
Fulfilment of treatment expectation
Fulfilment of treatment expectation, have your expectations been fulfilled: yes, yes partly, no
Satisfaction with the caregiver visits in the study
Patient enablement questionnaire
Adverse events/ side-effects
adverese events/ side effects of treatment in the study
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.
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.
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.
Interview study of employers
employers experience with interventions and their impact on work ability, health and work situation
Interview with managers
Interviews with managers regarding the experience of the convergence dialogue meeting
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.
Health related quality of life on vertical visual analogue scale
EQ thermometer
self-rated work situation regarding stress at work
work stress
self-rated work situation regarding work environment
work environment
self-rated work situation regarding satisfaction at work
workplace and work satisfaction
self-rated work situation regarding self-rated work performance
work performance
self-rated work situation regarding neck position at work
neck position
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04928989
Brief Title
Convergence Dialogue Meeting With or Without Neck-specific Exercise Promoting Work Ability
Acronym
WORKCIT
Official Title
What Does Web-based Neck-specific Exercise Add to a Digital Convergence Dialogue Meeting Promoting the Work Situation for Employees With Neck Pain?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding.
Study Start Date
May 2022 (Anticipated)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Workplace
Keywords
Neck pain, Workplace, Counceling, Exercise, Internet-based intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
The randomization will take place from a computer-based generated randomization list developed by a statistician. Randomization will be handled by a person not involved in intervention or evaluation. Investigators/ asessors will be blinded for randomization.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Convergence dialogue meeting
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Neck-specific exercise in addition to convergence dialogue meeting
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
convergence dialogue meeting
Intervention Description
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.
Primary Outcome Measure Information:
Title
Work Ability Score
Description
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
Secondary Outcome Measure Information:
Title
Intensity of pain and bothersomeness
Description
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
Title
Frequency of pain, symtoms and medications
Description
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
Title
Neck specific function
Description
Neck Disability Index
Time Frame
change from baseline to 3 month and 15 month follow-up
Title
Symptom satisfaction
Description
Symptom satisfaction according to Cherkin
Time Frame
change from baseline to 3 month and 15 month follow-up
Title
Exercise/physical activity level
Description
Exercise/physical activity level
Time Frame
change from baseline to 3 month and 15 month follow-up
Title
Health related quality of life
Description
EQ-5D-3L
Time Frame
change from baseline to 3 month and 15 month follow-up
Title
Fear avoidance
Description
Fear avoidance beliefs questionnaire
Time Frame
change from baseline to 3 month and 15 month follow-up
Title
self rated function
Description
Patient Specific Functional Scale
Time Frame
change from baseline to 3 month follow-up
Title
work situation
Description
description of work tasks
Time Frame
description and change from baseline to 3 month and 15 month follow-up
Title
self-rated work situation regarding working hours
Description
working hours
Time Frame
description and change from baseline to 3 month and 15 month follow-up
Title
perceived exertion at work
Description
Borg ratings of perceived exertion
Time Frame
change from baseline to 3 month and 15 month follow-up
Title
Work ability
Description
work ability index
Time Frame
change from baseline to 3 month and 15 month follow-up
Title
Sick leave,
Description
sick leave numbers of days/ month
Time Frame
change from baseline to 3 month and 15 month follow-up
Title
Presenteeism
Description
presenteeism number of days/ month and Stanford presenteeism scale
Time Frame
change from baseline to 3 month and 15 month follow-up
Title
Effort-Reward Imbalance
Description
Effort Reward Imbalance questionnaire
Time Frame
change from baseline to 3 month and 15 month follow-up
Title
Demand-control, support
Description
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
Title
Risk identifaction at work
Description
Structured multidisciplinary work evaluation tool
Time Frame
change from baseline to 3 month and 15 month follow-up
Title
work adaptation
Description
work adaptation such as self strategies to be able to work
Time Frame
change from baseline to 3 month and 15 month follow-up
Title
Time sitting
Description
Time sitting at work and during leisure time
Time Frame
change from baseline to 3 month and 15 month
Title
Anxiety and depression
Description
Hospital Anxiety and Depression scale
Time Frame
change from baseline to 3 month and 15 month follow-up
Title
Overall outcome
Description
Global rating of change scale
Time Frame
change from baseline to follw-ups at 3 month and 15 month
Title
Fulfilment of treatment expectation
Description
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
Title
Satisfaction with the caregiver visits in the study
Description
Patient enablement questionnaire
Time Frame
3 month, 15 month
Title
Adverse events/ side-effects
Description
adverese events/ side effects of treatment in the study
Time Frame
3 month, 15 month
Title
Cost-effectiveness
Description
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
Title
Saliva samples and blood samples
Description
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
Title
Microdialysis, tissue changes in the middle Trapezius
Description
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
Title
Interview study of employers
Description
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
Title
Interview with managers
Description
Interviews with managers regarding the experience of the convergence dialogue meeting
Time Frame
3 month, approximately n=20
Title
Observation study
Description
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
Title
Health related quality of life on vertical visual analogue scale
Description
EQ thermometer
Time Frame
change from baseline to 3 month and 15 month follow-up
Title
self-rated work situation regarding stress at work
Description
work stress
Time Frame
description and change from baseline to 3 month and 15 month follow-up
Title
self-rated work situation regarding work environment
Description
work environment
Time Frame
description and change from baseline to 3 month and 15 month follow-up
Title
self-rated work situation regarding satisfaction at work
Description
workplace and work satisfaction
Time Frame
description and change from baseline to 3 month and 15 month follow-up
Title
self-rated work situation regarding self-rated work performance
Description
work performance
Time Frame
description and change from baseline to 3 month and 15 month follow-up
Title
self-rated work situation regarding neck position at work
Description
neck position
Time Frame
description and change from baseline to 3 month and 15 month follow-up
Other Pre-specified Outcome Measures:
Title
profession
Description
Swedish standard for work classification
Time Frame
baseline
Title
Background data
Description
Age, gender, education, family situation, pain duration, expectations, smoking history
Time Frame
baseline
Title
ICD 10 code
Description
ICD 10 code decided after a physical examination
Time Frame
baseline
Title
Pain screening
Description
Örebro musculoskeletal pain screeing questionnaire
Time Frame
baseline
Title
screening for "yellow flags"- behaviour factors at risk
Description
START neck screening tool
Time Frame
baseline
Title
Treatment outside the study
Description
treatment outside the study
Time Frame
3 month, 15 month
Title
profession, open question
Description
open question regarding profession
Time Frame
description and change from baseline, 3 month and 15 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Anneli Peolsson
City
Linkoping
State/Province
Ostergotland
ZIP/Postal Code
58183
Country
Sweden
Facility Name
Dep. Medical and Health Sciences, Physiotherapy
City
Linköping
State/Province
Östergötland
ZIP/Postal Code
58183
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
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Convergence Dialogue Meeting With or Without Neck-specific Exercise Promoting Work Ability
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