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临床试验/NCT04169646
NCT04169646已完成不适用

On-site Multi-component Intervention to Improve Productivity and Reduce the Economic and Personal Burden of Neck Pain in Swiss Office-Workers

Zurich University of Applied Sciences4 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年10月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
4
主要终点
Change in NP-related productivity loss

研究概览

简要总结

This study is the first that investigates the impact of a multi-component intervention combining current evidence of effective interventions with an adherence app to assess the potential benefits on productivity, neck pain, and headache.

详细描述

Non-specific neck pain and headache are major economic and individual burdens in office-workers. The aim of this study is to investigate the effect of a multi-component intervention combining workstation ergonomics, health promotion information group workshops, neck exercises, and an app to enhance intervention adherence to assess possible reductions in the economic and individual burden of neck pain and headache in office workers.

This study is a stepped wedge cluster-randomized controlled trial. Eligible participants will be any office-worker aged 18-65 years from two Swiss organisations in the Canton of Zurich and Canton of Aargau, working more than 25 hours a week in predominantly sedentary office work and without serious health conditions of the neck. 120 voluntary participants will be assigned to 15 clusters which, at randomly selected time steps, switch from the control to the intervention group. The intervention will last 12 weeks and comprises workstation ergonomics, health promotion information group workshops, neck exercises and an adherence app. The primary outcome will be health-related productivity losses (presenteeism, absenteeism) using the Work Productivity and Activity Impairment Questionnaire. Secondary outcomes will include neck disability and pain. Physical and health outcomes (e.g. Neck Disability Index, muscle strength, and endurance), psychosocial outcomes (e.g. job-stress index, Fear-Avoidance Beliefs Questionnaire), workplace outcomes (e.g. workstation ergonomics), and individual outcomes (e.g. socio-demographic data, adherence to intervention) will be assessed. Measurements will take place at baseline, 4 months, 8 months, 12 months, 16 months, and 28 months after commencement. Data will be analysed on an 'intention to treat' basis and per protocol. Primary and secondary outcomes will be examined using linear mixed-effects models.

This study is the first that investigates the impact of a multi-component intervention combining current evidence of effective interventions with an adherence app to assess the potential benefits on productivity, neck pain, and headache. The outcomes will impact the individual, their workplace, as well as private and public policy by offering evidence for treatment and prevention of neck pain and headache in office-workers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

A senior bio-statistician blinded to the identity of individuals will randomise clusters to a sequence within the period of data collection when clusters change from the control to the intervention condition (group 1 to 3).

The outcome assessors of the physical examination will be blinded to group allocation and previous test results of the participants.

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

入选标准

  • Swiss office-workers, who suffer from NP or want to take prevention of neck pain or headache
  • 18-65 years old
  • working more than 25 hours per week (0.6 full-time equivalent) in predominantly sedentary office work
  • be able to communicate in German (written, spoken)
  • have provided written informed consent

排除标准

  • previous trauma or injuries to the neck (NP grade 4)
  • specific diagnosed pathologies (e.g., congenital cervical abnormalities, stenosis, fracture, radiculopathy)
  • inflammatory condition (e.g., rheumatoid arthritis)
  • any history of cervical spine surgery
  • if exercise is contraindicated (e.g., medical advice, own beliefs)
  • prolonged absence from work (more than four consecutive weeks) during the study intervention period
  • pregnant women

结局指标

主要结局

Change in NP-related productivity loss

时间窗: change from baseline at 16 months

Change in NP-related productivity loss will be measured in percentages of the working time, using the Work Productivity and Activity Impairment Questionnaire for Specific Health Problem (WPAI German version) and converted into monetary units using individual earnings. Absenteeism is assessed by asking the participants about the number of hours missed because of NP as well as the number of hours they have actually worked. To assess presenteeism, the participants are asked to indicate on a 10-score scale how much the NP affected productivity while working, with 0 indicating no effect on productivity and 10 indicating total disability. Scoring rules of the developers of the questionnaire will then be used to obtain self-reported absenteeism and presenteeism expressed as impairment percentages. The monetary value for the lost productivity will be obtained for each individual by multiplying the impairment percentages by the individual gross wage.

次要结局

  • Neck Disability Index(change from baseline at 16 months)
  • Neck pain(change from baseline at 16 months)

研究者

发起方
Zurich University of Applied Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Markus Melloh

Principal Investigator

Zurich University of Applied Sciences

研究点 (4)

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