The Effect of Sleep Ergonomics on Pain Low Back Pain
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Oswestry Disability Index (ODI) score
研究概览
简要总结
The aim of this study is to investigate the effect of sleep ergonomics guidance given by physiotherapist on pain and disability in patients with low back pain. In this randomized controlled trial participants are assigned either into the intervention or the control group. The intervention group will receive detailed instruction on sleeping ergonomics whereas the control group will only be instructed to avoid painful sleeping posture. The initial hypothesis is that in the intervention group pain and disability will decrease more compared to the control group.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low Back Pain
- •Pain during sleep or
排除标准
- •Fibromyalgia
- •Inflammatory rheumatic disease
- •Severe depression or other psychiatric diagnosis
- •Previously received specific guidance in sleep ergonomics
结局指标
主要结局
Oswestry Disability Index (ODI) score
时间窗: Change from baseline to 12 month follow-up
Oswestry Disability Index Finnish version 2.0 total score (scale 0-100%): 0 = minimal disability, 100 = bed-bound or exaggeration of symptoms; and sub-scores (scale 0-5): 0 = minimal disability, 5 = worst disability. Change is reported for total ODI score and sub-scores from baseline to 12 month follow-up.
Pain Visual Analog Scale (VAS)
时间窗: Change from baseline to 12 month follow-up
Low back pain reported with Visual Analog Scale (VAS) during rest, after getting up and during day; 0-100 mm scales, 0 mm = no pain, 100 mm = worst possible pain. Change from baseline to 12 month follow-up is reported in mm for each sub-scale (during rest, after getting up and during day).
次要结局
- Reported amount of sleep(Change from baseline to 12 month follow-up)
- Number of sick leave days(Change from baseline to 12 month follow-up)
研究者
Jari Ylinen
Chief Physician
Central Finland Hospital District