NCT00361556已完成2 期
Treatment for Nonspecific Low Back Pain in Primary Care With Standardized Health Education Booklets: A Randomized Controlled Clinical Trial
Kovacs Foundation1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2005年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Degree of disability at 180 days of follow-up.
研究概览
简要总结
The primary purpose of this study is to compare the effectiveness on the disability of low back pain patients of The Back Book, The Back Guide, and a control intervention (generic recommendations on general health). Patients are divided into 3 groups:those who receive The Back Book (classic education), those who receive The Back Guide (cognitive behavioral education) and the control group). They are patients who consult a physician at the primary care consults of 14 different Health Centers in Spain. The sample size is 240 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
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 patients,
- •with or without referred or radiated pain;
- •without red flags for systemic disease or criteria for surgery.
排除标准
- •Inability to read the handout or to fill out the questionnaires;
- •habitually in a prostrate position;
- •diagnosis of inflammatory rheumatologic disease, cancer or fibromyalgia; suspicion of fibromyalgia.
结局指标
主要结局
Degree of disability at 180 days of follow-up.
时间窗: 6 months
次要结局
- Catastrophizing and days on sick leave at 180 days of follow-up.(6 months)
研究者
Francisco M. Kovacs
Carmen Fernández, Centro de Salud de Valldargent
Kovacs Foundation
研究点 (1)
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