Effect of Dynamic Sitting on Pain Development - Part 2 - a Randomized Controlled Cross-over Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean change in subjective lower back pain (before vs. after work, weekly average) estimated by visual analogue scale (VAS)
研究概览
简要总结
As a follow-up project to the Dyn-Sit-Pain study, this research aims to investigate the overall health as well as the physical and mental well-being through dynamic office chairs. The development of an innovative dynamic office chair concept will be professionally and scientifically supported, and the developed prototypes will be examined within the framework of usability studies.
详细描述
This clinical trial is a prospective, randomised, controlled, open-label study with two tracks, each in a cross-over design investigating the effect of of two dynamic office chairs (saddle chair with standard pendulum mechanism [Smart Moving Technology], study track 2 = office swivel chair with integrated newly developed pendulum mechanism [Smart Moving Technology New]) on the musculoskeletal system of office workers classified as pain developers.
The study consists of a pre-screening visit and 4 assessment days / visits. After proving eligibility for the study (inclusion/exclusion criteria), subjects are assigned to one of the two study tracks. Subjects are randomised to one of the two study tracks and then to the respective group (Group A to D).
- Study track 1: saddle chair with standard pendulum mechanism (= intervention 1) + static office chair (= control)
- Study track 2: office swivel chair with integrated newly developed pendulum mechanism (= intervention 2) + static office chair (= control).
Depending on the study track and group allocation, the test subjects first receive a dynamic office chair (= intervention) or a static office chair (= control). The randomization will be realized with opaque envelopes in different colours and follows international recommendations.
Overall participants will execute identical assessments. A wash-put period between the control and the intervention phases ensures identical baseline conditions. The overall duration of study participation equals 16 weeks.
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
- None
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
- 是
入选标准
- •Signed Informed consent
- •People aged between 18 and 65 years
- •People classified as pain developers (e.g.: a 10 mm increase in pain on a 100 mm paper-based VAS)
- •Office workers
- •Employment status: > 25 h / week
- •Sufficient knowledge of German (min. B2 level)
- •Body height of at least 160cm required
- •Electrically or manually height-adjustable table at main workstation
排除标准
- •Physical or mental limitations that make dynamic sitting or use of the procedure chair difficult (e.g. wheelchair users, vestibular dysfunction)
- •Pregnancy
- •Sitting for less than 20 hours per week at the main workplace
- •Body weight over 110 kg and a body height over 195 cm
- •Regular therapy or medication for pain or medication that affects the perception of pain (e.g. certain psychotropic drugs according to the package leaflet)
- •office chair to which it is not possible to attach the swivel mechanism prototype
- •Presence of any chronic disease that may influence pain perception (e.g., chronic kidney disease, fibromyalgia, neuropathy, chronic fatigue syndrome)
研究组 & 干预措施
Study Track 1: Group A
The pre-existing static office chair will be used in the personal workplace for the first 6 weeks within the first half of the study. A wash-out period of a minimum of 4 weeks will be executed after the first half of the study. A dynamic office chair (saddle chair with standard pendulum mechanism) will be used on the personal workstation for 6 weeks within the second half of the study after the wash-out period.
干预措施: Dynamic office chair (saddle chair with standard pendulum mechanism) (Device)
Study Track 1: Group B
A dynamic office chair (saddle chair with standard pendulum mechanism) will be used in the personal workplace for the first 6 weeks within the first half of the study. A wash-out period of a minimum of 4 weeks will be executed after the first half of the study. The pre-existing static office chair will be used on the personal workstation for 6 weeks within the second half of the study after the wash-out period.
干预措施: Dynamic office chair (saddle chair with standard pendulum mechanism) (Device)
Study Track 2: Group C
The pre-existing static office chair will be used in the personal workplace for the first 6 weeks within the first half of the study. A wash-out period of a minimum of 4 weeks will be executed after the first half of the study. A dynamic office chair (office swivel chair with integrated newly developed pendulum mechanism) will be used on the personal workstation for 6 weeks within the second half of the study after the wash-out period.
干预措施: Dynamic Office Chair (office swivel chair with integrated newly developed pendulum mechanism) (Device)
Study Track 2: Group D
A dynamic office chair (office swivel chair with integrated newly developed pendulum mechanism) will be used in the personal workplace for the first 6 weeks within the first half of the study. A wash-out period of a minimum of 4 weeks will be executed after the first half of the study. The pre-existing static office chair will be used on the personal workstation for 6 weeks within the second half of the study after the wash-out period.
干预措施: Dynamic Office Chair (office swivel chair with integrated newly developed pendulum mechanism) (Device)
结局指标
主要结局
Mean change in subjective lower back pain (before vs. after work, weekly average) estimated by visual analogue scale (VAS)
时间窗: 6 weeks
Participants will rate their subjectively perceived lower back pain before and after a conventional occupational day on 5 consecutive days starting at baseline (week 1) and ending with the post-intervention visit (week 6). Subjectively perceived lower back pain will be assessed with a Visual Analogue Scale (VAS). The VAS used for this study ranges from 0 (none) to 100 points (strongest pain imaginable). Question: Please rate the level of your lower back pain at this moment.
次要结局
- Mean change in subjective mental fatigue (before vs. after work, weekly average) estimated by VAS(6 weeks)
- Mean subjectively rated work performance (after work, weekly average) estimated by VAS(6 weeks)
- Number of adverse events estimated from an AEs form sheet(16 weeks)
- Change in impact of pain on the daily life (pre vs. post intervention) estimated by ODI-D(6 weeks)
- Usability estimated using the UEQS questionnaire(6 weeks)
- Sitting behaviors estimated by microcontrollers(6 weeks)