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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Workplace
• Intervention / Treatment: Other: convergence dialogue meeting

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Ostergotland
    • Linkoping, Ostergotland, Sweden, 58183
      • Anneli Peolsson
  • Östergötland
    • Linköping, Östergötland, Sweden, 58183
      • Dep. Medical and Health Sciences, Physiotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: Neck-specific exercise in addition to 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
profession	Swedish standard for work classification	baseline
Background data	Age, gender, education, family situation, pain duration, expectations, smoking history	baseline
ICD 10 code	ICD 10 code decided after a physical examination	baseline
Pain screening	Örebro musculoskeletal pain screeing questionnaire	baseline
screening for "yellow flags"- behaviour factors at risk	START neck screening tool	baseline
Treatment outside the study	treatment outside the study	3 month, 15 month
profession, open question	open question regarding profession	description and change from baseline, 3 month and 15 month follow-up

Collaborators and Investigators

• Sponsor: Linkoeping University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): December 1, 2026
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): July 11, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Exercise; Workplace; Neck pain; Internet-based intervention; Counceling
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 2021-00373

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No