NCT00439764已完成2 期
Health Education vs. Health Education Plus Physical Therapy for Low Back Pain Patients
Kovacs Foundation2 个研究点 分布在 1 个国家目标入组 680 人开始时间: 2007年3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
- 680
- 试验地点
- 2
- 主要终点
- Intensity of pain, measured at baseline, 90, and 180 days later
研究概览
简要总结
The primary purpose of this study is to assess the effectiveness of a brief educational program and of an additional program in physical therapy, for the treatment of low back pain in Primary Care of the Spanish National Health Service. This is a controlled, cluster randomized community trial.
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
- 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
- •Consultation for low back pain, with or without referred or radiated pain; no signs of systemic disease or criteria for surgery.
排除标准
- •Inability to fill out the questionnaires (blindness, dementia, illiteracy; total habitual prostration;
- •Diagnosis of rheumatologic inflammatory disease, fibromyalgia or cancer in last 5 years;
- •Suspicion of fibromyalgia.
结局指标
主要结局
Intensity of pain, measured at baseline, 90, and 180 days later
时间窗: 6 months
Disability, measured at baseline, 90, and 180 days later
时间窗: 6 months
Sick leave, measured at baseline, 90, and 180 days later
时间窗: 6 months
次要结局
- Fear avoidance beliefs, measured at baseline, 90, and 180 days later(6 months)
- Quality of life, measured at baseline, 90, and 180 days later(6 months)
研究者
研究点 (2)
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