Clinical trial NCT04928989: Convergence Dialogue Meeting With or Without Neck-specific Exercise Promoting Work Ability
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
Overall status: WITHDRAWN
Phase: NA
Conditions: Workplace
Keywords: Neck pain
Workplace
Counceling
Exercise
Internet-based intervention
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2021-06-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Work Ability Score
timeFrame: Change in work Ability Score from baseline, to every month until the 15 month follow-up
Secondary outcomes:
measure: Intensity of pain and bothersomeness
timeFrame: change from baseline to 3 month and 15 month follow-up
measure: Frequency of pain, symtoms and medications
timeFrame: change from baseline to 3 month and 15 month follow-up
measure: Neck specific function
timeFrame: change from baseline to 3 month and 15 month follow-up
measure: Symptom satisfaction
timeFrame: change from baseline to 3 month and 15 month follow-up
measure: Exercise/physical activity level
timeFrame: change from baseline to 3 month and 15 month follow-up
measure: Health related quality of life
timeFrame: change from baseline to 3 month and 15 month follow-up
measure: Fear avoidance
timeFrame: change from baseline to 3 month and 15 month follow-up
measure: self rated function
timeFrame: change from baseline to 3 month follow-up
measure: work situation
timeFrame: description and change from baseline to 3 month and 15 month follow-up
measure: self-rated work situation regarding working hours
timeFrame: description and change from baseline to 3 month and 15 month follow-up
measure: perceived exertion at work
timeFrame: change from baseline to 3 month and 15 month follow-up
measure: Work ability
timeFrame: change from baseline to 3 month and 15 month follow-up
measure: Sick leave,
timeFrame: change from baseline to 3 month and 15 month follow-up
measure: Presenteeism
timeFrame: change from baseline to 3 month and 15 month follow-up
measure: Effort-Reward Imbalance
timeFrame: change from baseline to 3 month and 15 month follow-up
measure: Demand-control, support
timeFrame: change from baseline to 3 month and 15 month follow-up
measure: Risk identifaction at work
timeFrame: change from baseline to 3 month and 15 month follow-up
measure: work adaptation
timeFrame: change from baseline to 3 month and 15 month follow-up
measure: Time sitting
timeFrame: change from baseline to 3 month and 15 month
measure: Anxiety and depression
timeFrame: change from baseline to 3 month and 15 month follow-up
measure: Overall outcome
timeFrame: change from baseline to follw-ups at 3 month and 15 month
measure: Fulfilment of treatment expectation
timeFrame: 3 month and 15 month related to the patient own expectations
measure: Satisfaction with the caregiver visits in the study
timeFrame: 3 month, 15 month
measure: Adverse events/ side-effects
timeFrame: 3 month, 15 month
measure: Cost-effectiveness
timeFrame: From the time period between baseline to 15 month follow-up
measure: Saliva samples and blood samples
timeFrame: change from baseline to 3 month in a subgroup of the RCT population, all those who agree and are without contra indication
measure: Microdialysis, tissue changes in the middle Trapezius
timeFrame: baseline, 3 month, subgroup of the RCT population approximately n=30
measure: Interview study of employers
timeFrame: 3 month, subgroup of the RCT population, n=20 approximately
measure: Interview with managers
timeFrame: 3 month, approximately n=20
measure: Observation study
timeFrame: During the 3 month treatment period at tripartiate convergence dialogue meeting
measure: Health related quality of life on vertical visual analogue scale
timeFrame: change from baseline to 3 month and 15 month follow-up
measure: self-rated work situation regarding stress at work
timeFrame: description and change from baseline to 3 month and 15 month follow-up
measure: self-rated work situation regarding work environment
timeFrame: description and change from baseline to 3 month and 15 month follow-up
measure: self-rated work situation regarding satisfaction at work
timeFrame: description and change from baseline to 3 month and 15 month follow-up
measure: self-rated work situation regarding self-rated work performance
timeFrame: description and change from baseline to 3 month and 15 month follow-up
measure: self-rated work situation regarding neck position at work
timeFrame: description and change from baseline to 3 month and 15 month follow-up
Other outcomes:
measure: profession
timeFrame: baseline
measure: Background data
timeFrame: baseline
measure: ICD 10 code
timeFrame: baseline
measure: Pain screening
timeFrame: baseline
measure: screening for "yellow flags"- behaviour factors at risk
timeFrame: baseline
measure: Treatment outside the study
timeFrame: 3 month, 15 month
measure: profession, open question
timeFrame: description and change from baseline, 3 month and 15 month follow-up
Locations:
city: Linkoping
country: Sweden
facility: Anneli Peolsson
state: Ostergotland
city: Linköping
country: Sweden
facility: Dep. Medical and Health Sciences, Physiotherapy
state: Östergötland
Study officials:
References: