NCT00360802已完成2 期
The Effectiveness of Cognitive Behavioral Treatment and Mindfulness Based Stress Reduction for Chronic Low Back Pain Treated in Pain Clinics
Kovacs Foundation2 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2006年5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
- 330
- 试验地点
- 2
- 主要终点
- Degree of improvement in: anxiety, quality of life
研究概览
简要总结
The primary purpose of this study is to determine the effectiveness of two psychological techniques in chronic low back pain patients treated in hospital pain clinics. The techniques are: cognitive behavioral treatment and mindfulness based stress reduction (MBSR). This is a multiple site project in which patients come from 16 different pain clinics throughout Spain. The control group is formed by patients under usual medical treatment at pain clinics. The two intervention groups also receive usual medical treatment at pain clinics plus one psychological therapy treatment. The sample size is 330 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic low back pain and failed back surgery patients
- •With or without referred or radiated pain
- •Who are between 18 and 70 years of age (inclusive)
排除标准
- •Patients with red flags for systemic disease or criteria for surgery
- •With intolerable intensity of pain despite 6 weeks or more of non-surgical treatment
- •With pain that appears only on walking and disappears with sitting, persists after 6 months of conservative treatment, and is a possible spinal stenosis
- •Under psychological or psychiatric treatment
- •Unable to fill out the questionnaires
- •Have received cognitive behavioral treatment in the past
- •Have ongoing work litigation or are in the process of obtaining permanent disability.
结局指标
主要结局
Degree of improvement in: anxiety, quality of life
时间窗: immediately after therapy, at 3 months, and at 12 months
次要结局
- Degree of improvement in: pain, disability, catastrophizing, depression, anger, analgesic medication, satisfaction with treatment received(immediately after therapy, at 3 months, and at 12 months)
研究者
研究点 (2)
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