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临床试验/NCT04783454
NCT04783454招募中不适用

Preventing Neck & Back Pain in Teleworking Office Workers: a Randomized Controlled Trial

University Ghent1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2020年11月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
600
试验地点
1
主要终点
low back pain

研究概览

简要总结

The purpose of this study is to assess the effect of a general training program and educational session to prevent neck and/or low back pain in desktop workers

详细描述

After being informed about the study and potential risks, all subjects that met the preset inclusion criteria and gave written informed consent to participate will be randomized into an intervention or control group in a 1:1 ratio. Next, subjects of both groups will undergo baseline testing (online survey). The subjects of the intervention group receive a single educational video (online) and are motivated to follow 2 training sessions of 60 minutes each, during 12 consecutive weeks. Instructions for the specific exercises are provided via an online platform. The subjects of the control group are instructed to maintain their normal working activities and activities of daily life and receive no further intervention. Subjects of both groups are prompted to fill out a weekly online logbook to gather information on their physical activity and neck and/or back complaints. All subjects undergo post-intervention testing at 12 weeks (short term effects), 6 months, and 12 months (long term effects).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

All investigators and outcome assessors are blind to the subjects' allocation

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •age between 18-69 years
  • •perform regular desktop work (at least 20 hours/week)
  • •perform desktop work for at least 1 year (employee or student)

排除标准

  • •documented structural neck- and/or back pathology (confirmed by medical imaging)
  • •known shoulder or vestibular pathology
  • •whiplash-associated disorders
  • •history of surgery in the neck, shoulder, hip, and/or back area
  • •(history of) chronic pain condition
  • •serious headache
  • •serious cardiovascular/metabolic/systemic/neurological conditions
  • •chronic fatigue syndrome
  • •fibromyalgia
  • •psychiatric conditions or history of serious depression
  • •serious catastrophizing thoughts
  • •pregnancy or delivery in the past year

研究组 & 干预措施

Intervention

Experimental
  • single (online) educational video on how the prevention program is designed and general advice on (how to adopt) a healthy lifestyle
  • 12-week training program: 2 sessions of 60 minutes per week, with the focus of the first session on cardiovascular exercises, and the focus of the second session on mobility and strengthening exercises

干预措施: Exercise program (Other)

control

No Intervention

no intervention (wait and see approach)

结局指标

主要结局

low back pain

时间窗: 1 year

Did you develop low back pain (YES or NO)

neck pain

时间窗: 1 year

Did you develop neck pain (YES or NO)

次要结局

  • Depression Anxiety Stress Scale-21 (DASS-21 questionnaire)(1year)
  • use of (pain) medication and/or (para)medical care(1year)
  • behavioral change(1 year)
  • global perceived effect(1year)
  • physical activity (Baecke Questionnaire)(1year)
  • time to exposure(1year)
  • 36-Item Short Form Health Survey (SF-36 questionnaire)(1year)
  • Insomnia severity index (ISI questionnaire)(1year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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