The Effects of Unstable Shoes on Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from baseline in low back pain at 6 weeks
研究概览
简要总结
Some physicians, physiotherapists and nurses use or even suggest unstable shoes in cases of low back pain. No studies on the real effects of these shoes on low back pain in health care professions have been carried out and therefore as yet there is no real evidence of their effectiveness. Thus the investigators assume that wearing unstable shoes over a period of six weeks could reduce low back pain and functional disability due to the changes of the gait and posture and may increase the quality of life.
The purposes of this study are:
- To evaluate the modifications of pain level, functional capacity and quality of life among individuals with moderate level of non-specific chronic low back pain after wearing unstable shoes.
- To quantify biomechanical modifications of gait and posture.
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
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change from baseline in low back pain at 6 weeks
时间窗: Baseline and 6 weeks
Low back pain level with the visual analogue scale (VAS) from 0 to 10;
Change from baseline in the Roland-Morris disability questionnaire at 6 weeks
时间窗: Baseline and 6 weeks
functional disability with the Roland-Morris disability questionnaire (this questionnaire has been validated in French as the Functional Disability Scale for the Assessment of Low Back Pain - Eifel)
Change from baseline in the EQ-5D quality of life questionnaire at 6 weeks
时间窗: Baseline and 6 weeks
Quality of life with the EQ-5D.
次要结局
- Change from baseline in gait speed at 6 weeks(Baseline and 6 weeks)
- Change from baseline in balance performance at 6 weeks(Baseline and 6 weeks)
- Change from baseline in ankle dorsiflexion during gait at 6 weeks(Baseline and 6 weeks)
- Change from baseline in pelvis anteversion during gait at 6 weeks(Baseline and 6 weeks)
- Change from baseline in trunk anteversion during gait at 6 weeks(Baseline and 6 weeks)
- Change from baseline in activation period of lower-limb muscles during gait at 6 weeks(Baseline and 6 weeks)
- Change from baseline in activation period of erector spinae during gait at 6 weeks(Baseline and 6 weeks)
- Change from baseline in maximum knee extension during gait stance phase at 6 weeks(Baseline and 6 weeks)
研究者
Armand Staphane
PhD
University Hospital, Geneva