What Does Web-based Neck-specific Exercise Add to a Digital Convergence Dialogue Meeting Promoting the Work Situation for Employees With Neck Pain?
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- Work Ability Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Work Ability Score
时间窗: Change in work Ability Score from baseline, to every month until the 15 month follow-up
Current work ability compared to when it was at its best
次要结局
- Neck specific function(change from baseline to 3 month and 15 month follow-up)
- Exercise/physical activity level(change from baseline to 3 month and 15 month follow-up)
- Time sitting(change from baseline to 3 month and 15 month)
- Intensity of pain and bothersomeness(change from baseline to 3 month and 15 month follow-up)
- Health related quality of life(change from baseline to 3 month and 15 month follow-up)
- self rated function(change from baseline to 3 month follow-up)
- Work ability(change from baseline to 3 month and 15 month follow-up)
- Presenteeism(change from baseline to 3 month and 15 month follow-up)
- Demand-control, support(change from baseline to 3 month and 15 month follow-up)
- Frequency of pain, symtoms and medications(change from baseline to 3 month and 15 month follow-up)
- Symptom satisfaction(change from baseline to 3 month and 15 month follow-up)
- self-rated work situation regarding working hours(description and change from baseline to 3 month and 15 month follow-up)
- perceived exertion at work(change from baseline to 3 month and 15 month follow-up)
- Risk identifaction at work(change from baseline to 3 month and 15 month follow-up)
- Fulfilment of treatment expectation(3 month and 15 month related to the patient own expectations)
- Adverse events/ side-effects(3 month, 15 month)
- Cost-effectiveness(From the time period between baseline to 15 month follow-up)
- Interview with managers(3 month, approximately n=20)
- self-rated work situation regarding satisfaction at work(description and change from baseline to 3 month and 15 month follow-up)
- Fear avoidance(change from baseline to 3 month and 15 month follow-up)
- work situation(description and change from baseline to 3 month and 15 month follow-up)
- work adaptation(change from baseline to 3 month and 15 month follow-up)
- Anxiety and depression(change from baseline to 3 month and 15 month follow-up)
- self-rated work situation regarding self-rated work performance(description and change from baseline to 3 month and 15 month follow-up)
- self-rated work situation regarding neck position at work(description and change from baseline to 3 month and 15 month follow-up)
- Sick leave,(change from baseline to 3 month and 15 month follow-up)
- Effort-Reward Imbalance(change from baseline to 3 month and 15 month follow-up)
- Satisfaction with the caregiver visits in the study(3 month, 15 month)
- Microdialysis, tissue changes in the middle Trapezius(baseline, 3 month, subgroup of the RCT population approximately n=30)
- Health related quality of life on vertical visual analogue scale(change from baseline to 3 month and 15 month follow-up)
- self-rated work situation regarding work environment(description and change from baseline to 3 month and 15 month follow-up)
- Overall outcome(change from baseline to follw-ups at 3 month and 15 month)
- Interview study of employers(3 month, subgroup of the RCT population, n=20 approximately)
- Saliva samples and blood samples(change from baseline to 3 month in a subgroup of the RCT population, all those who agree and are without contra indication)
- Observation study(During the 3 month treatment period at tripartiate convergence dialogue meeting)
- self-rated work situation regarding stress at work(description and change from baseline to 3 month and 15 month follow-up)
研究者
Anneli Peolsson
Professor, PhD, MSc PT, MSc HRMD
Linkoeping University