NCT01403168终止不适用
Comparative Evaluation of Osteopathy Treatment Efficacy in Pain Support After Breast Surgery in Oncology
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Efficacy of the osteopathy treatment on pain
研究概览
简要总结
This is an open, prospective, controlled, randomized, comparative study with 2 arms.
The purpose of the study is to assess the efficacy of osteopathy after breast surgery.
80 patients will be enrolled, 40 per arm. Patients will be randomized at inclusion and will be followed during one year.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •woman >= 18 years
- •pain (median VAS >=3 on the week prior to inclusion)
- •mastectomy or tumorectomy with axillary dissection <= 12 months
- •able to write, understand and read French
- •signed informed consent
排除标准
- •immediate breast reconstruction
- •history of cognitive or psychiatric troubles
结局指标
主要结局
Efficacy of the osteopathy treatment on pain
时间窗: 3 months
Pain is assessed by means of visual analogic scale (from 0 to 10 points). A decrease of 2 points after 3 months is expected.
次要结局
未报告次要终点
研究者
研究点 (2)
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