Study to Compare a Cognitive-behavioral Treatment With a Cognitive-behavioral Treatment With Biofeedback Elements to Patients With Chronic (Low) Back Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- pain intensity
研究概览
简要总结
The purpose of the study:
- to compare two cognitive-behavioral treatments
详细描述
128 patients suffering from chronic back pain were randomly assigned to either Wait List Control, Cognitive Behavioral Treatment or Cognitive Behavioral Treatment and Biofeedback.
Measures were conducted 6 months before treatment (Wait List Control) immediately before and after treatment and at 6-months follow-up.
25 weekly 1-hr sessions of individualized outpatient cognitive behavioral treatment of chronic back pain
Treatment elements:
Cognitive treatment: identification, evaluation and correction of dysfunctional beliefs about themselves and pain by cognitive restructuring, problem-solving training and coping skills training
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Back pain since 6 months
排除标准
- •Patients with psychosis, borderline psychopathy, drug dependence i.e. alcohol
研究组 & 干预措施
1
cognitive-behavioral treatment
干预措施: cognitive-behavioral treatment (Behavioral)
2
cognitive-behavioral treatment with biofeedback elements
干预措施: cognitive-behavioral treatment (Behavioral)
结局指标
主要结局
pain intensity
时间窗: start of treatment, end of treatment, 6-months follow-up
次要结局
- depression(start of treatment, end of treatment, 6-months folow-up)
- pain disability(start of treatment, end of treatment, 6-months follow-up)
研究者
Winfried Rief
Professor Dr.
Philipps University Marburg Medical Center