Effect of Dynamic Sitting on Pain Development in Adult Pain Developers in Sedentary Environments - a Randomized Controlled Cross-over Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Mean change in subjectively perceived lower back pain as determined with a Visual Analogue Scale (VAS)
研究概览
简要总结
Worksite based prolonged static sitting postures can cause musculoskeletal pain. While the development of pain increases due to the constant growth of digitalization at work, numerous interventions to reduce prolonged sitting periods have been created. The effects of such interventions have not yet been properly examined. Thus, the "DynSit-Pain" project was initiated to investigate the influence of dynamic sitting on the pain development of pain developers in office environments.
详细描述
This clinical investigation is a prospective, randomized, controlled, counter-balanced, two-arm field study investigating the effect of dynamic sitting on musculoskeletal pain in office workers classified as pain developers.
The study consists of a pre-screening visit and 4 assessment days / visits. During this pre-screening visit and after proving the study eligibility (inclusion / exclusion criteria), half of the study participants will randomly be allocated to one of the two study arms. Depending on the arm allocation, participants will receive a dynamic (= intervention) or static (= control) office chair for 6 weeks. After a wash-out of at least 4 weeks the 6-week intervention resp. control will be switched. The randomization will be realized with opaque envelopes.
Overall participants will execute the identical assessments within the control and the intervention chair group. The wash-out phase between the control and the intervention periods will ensue identical baseline conditions for both chairs. The overall duration of study participation amounts to 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., increase of pain of 10 mm on a 100 mm paper based visual analogue scale) determined by pre-screening
- •Office workers
- •Employment status: > 30 h / week
- •Sufficient German language skills (minimum B2 level)
- •Table height of at least 63 cm at the main workplace
排除标准
- •Physical or mental limitations that aggravate dynamic sitting or using the interventional chair (e.g., wheel chair users, vestibular dysfunctions)
- •Pregnancy
- •Working in sitting posture for less than 20 hours per working week in the main workplace.
- •Bodyweight over 110 kg and a body height over 195 cm
- •Regular therapy or medication for pain
结局指标
主要结局
Mean change in subjectively perceived lower back pain as determined with a 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
- User's experience estimated with the User Experience Questionnaire-Short version (UEQ-S)(6 weeks)
- Mean change in subjectively perceived mental fatigue (pre- vs. post-work, weekly average) estimated via Visual Analogue Scale (VAS)(6 weeks)
- Mean subjectively rated working performance (post-work, weekly average) estimated via VAS(6 weeks)
- User's experience via qualitative interview(6 weeks)
- Change in quality of life (pre- vs. post-intervention) estimated via 5-level EuroQol quality of life questionnaire (EQ-5D-5L)(6 weeks)
- Number of adverse events (AE) estimated via an adverse event form sheet(16 weeks)
- Sitting behaviors estimated via microcontrollers(During the 6 weeks of the period of intervention)
- Change in impact of pain on daily life (pre- vs. post-intervention) estimated with the German version of the Oswestry Disability Index (ODI-D)(6 weeks)
研究者
Bernhard Schwartz
Principal Investigator
University of Applied Sciences for Health Professions Upper Austria