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

Workplace Clinical Trial

— 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?

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04928989
• Other study ID #: 2021-00373
• Status: Withdrawn
• Phase: N/A
• Start date: May 2022
• Est. completion date: December 2026

Study information

• Verified date: April 2022
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neck Pain
• Workplace

Intervention

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.

Locations

Country	Name	City	State
Sweden	Anneli Peolsson	Linkoping	Ostergotland
Sweden	Dep. Medical and Health Sciences, Physiotherapy	Linköping	Östergötland

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	profession	Swedish standard for work classification	baseline
Other	Background data	Age, gender, education, family situation, pain duration, expectations, smoking history	baseline
Other	ICD 10 code	ICD 10 code decided after a physical examination	baseline
Other	Pain screening	Örebro musculoskeletal pain screeing questionnaire	baseline
Other	screening for "yellow flags"- behaviour factors at risk	START neck screening tool	baseline
Other	Treatment outside the study	treatment outside the study	3 month, 15 month
Other	profession, open question	open question regarding profession	description and change from baseline, 3 month and 15 month follow-up
Primary	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	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
Secondary	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
Secondary	Neck specific function	Neck Disability Index	change from baseline to 3 month and 15 month follow-up
Secondary	Symptom satisfaction	Symptom satisfaction according to Cherkin	change from baseline to 3 month and 15 month follow-up
Secondary	Exercise/physical activity level	Exercise/physical activity level	change from baseline to 3 month and 15 month follow-up
Secondary	Health related quality of life	EQ-5D-3L	change from baseline to 3 month and 15 month follow-up
Secondary	Fear avoidance	Fear avoidance beliefs questionnaire	change from baseline to 3 month and 15 month follow-up
Secondary	self rated function	Patient Specific Functional Scale	change from baseline to 3 month follow-up
Secondary	work situation	description of work tasks	description and change from baseline to 3 month and 15 month follow-up
Secondary	self-rated work situation regarding working hours	working hours	description and change from baseline to 3 month and 15 month follow-up
Secondary	perceived exertion at work	Borg ratings of perceived exertion	change from baseline to 3 month and 15 month follow-up
Secondary	Work ability	work ability index	change from baseline to 3 month and 15 month follow-up
Secondary	Sick leave,	sick leave numbers of days/ month	change from baseline to 3 month and 15 month follow-up
Secondary	Presenteeism	presenteeism number of days/ month and Stanford presenteeism scale	change from baseline to 3 month and 15 month follow-up
Secondary	Effort-Reward Imbalance	Effort Reward Imbalance questionnaire	change from baseline to 3 month and 15 month follow-up
Secondary	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
Secondary	Risk identifaction at work	Structured multidisciplinary work evaluation tool	change from baseline to 3 month and 15 month follow-up
Secondary	work adaptation	work adaptation such as self strategies to be able to work	change from baseline to 3 month and 15 month follow-up
Secondary	Time sitting	Time sitting at work and during leisure time	change from baseline to 3 month and 15 month
Secondary	Anxiety and depression	Hospital Anxiety and Depression scale	change from baseline to 3 month and 15 month follow-up
Secondary	Overall outcome	Global rating of change scale	change from baseline to follw-ups at 3 month and 15 month
Secondary	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
Secondary	Satisfaction with the caregiver visits in the study	Patient enablement questionnaire	3 month, 15 month
Secondary	Adverse events/ side-effects	adverese events/ side effects of treatment in the study	3 month, 15 month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Interview with managers	Interviews with managers regarding the experience of the convergence dialogue meeting	3 month, approximately n=20
Secondary	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
Secondary	Health related quality of life on vertical visual analogue scale	EQ thermometer	change from baseline to 3 month and 15 month follow-up
Secondary	self-rated work situation regarding stress at work	work stress	description and change from baseline to 3 month and 15 month follow-up
Secondary	self-rated work situation regarding work environment	work environment	description and change from baseline to 3 month and 15 month follow-up
Secondary	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
Secondary	self-rated work situation regarding self-rated work performance	work performance	description and change from baseline to 3 month and 15 month follow-up
Secondary	self-rated work situation regarding neck position at work	neck position	description and change from baseline to 3 month and 15 month follow-up