NCT04725344终止不适用
Relevance of the Activ'Dos App for Chronic Low Back Pain Patients - Randomized Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 8
- 主要终点
- Change from functional impairment with Roland-Morris questionnaire at 6 weeks.
研究概览
简要总结
The purpose of this study is to compare a self rehabilitation program using ACTIV'DOS app versus using a standard sheet of paper.
详细描述
This study involves patients with chronic low back pain. The purpose of this study is to compare a self-rehabilitation program using ACTIV'DOS app versus a standard sheet of paper. Disabilities are measured with a Roland-Morris questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic low back pain for more than 3 months
- •Aged to 18 or more
- •Possibility to use Activ'dos application with smartphone or tablet
- •Initial score of Roland Morris questionnaire >= 4
- •Fit to consent
- •Who has signed consent form
排除标准
- •Any signs of severe illness underlying to radicular and lumbar pain like red flags
- •Guardianship or protection of vulnerable adult
- •Pregnant or nursing
- •Refuse to participate
结局指标
主要结局
Change from functional impairment with Roland-Morris questionnaire at 6 weeks.
时间窗: Day 0 (patient inclusion) and Day 42 (end of patient monitoring)
Disabilities are measured with Roland-Morris questionnaire, from Day 0 to Day 42. This questionnaire includes 24 items with 1 point per item. The score ranges from 0 (no disability) to 24 (max. disability).
次要结局
- Assessment of satisfaction with Likert scale(Day 42 (end of patient monitoring))
- Difference of worse pain during the seven last days with VAS pain(Day 0 (patient inclusion) and Day 42 (end of patient monitoring))
- Difference of average pain during the seven last days with VAS pain(Day 0 (patient inclusion) and Day 42 (end of patient monitoring))
- Compliance (number of sessions done over the number of recommanded sessions) of self-rehabilitation program at 6 weeks(Day 42 (end of patient monitoring))
研究者
研究点 (8)
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