NCT00993980已完成不适用
Randomized Multicenter Trial on the Effectiveness of Qigong and a Stabilizing Exercise Therapy in Patients With Low Back Pain
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- average pain intensity during the last 7 days measured on a visual analogue scale (VAS)
研究概览
简要总结
The purpose of this study is to assess the effectiveness of qigong for the treatment of low back pain compared to a stabilizing exercise therapy.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of chronic low back pain since at least 3 months and complaints for a maximum duration of 5 years
- •low back pain more prominent than other pain in the spine
- •average pain intensity of the last 7 days more or equal to 40 mm measured by a visual analogue scale (VAS 0 - 100 mm)
- •intellectual and physical ability to participate in the study
- •informed consent
排除标准
- •low back pain related to malignancy
- •low back pain due to an accident
- •inflammatory joint disorders
- •previous spine surgery
- •protrusion/prolapse of a spinal disk, spondylolisthesis, with radicular symptomatology
- •actually doing or planning to do other regular physical exercise during the study with possible positive effects on low back pain - such as swimming, yoga, pilates, tai chi, etc.
- •planning to do another therapy during the study with possible positive effects in low back pain, such as physiotherapy, acupuncture, massage, spinal manipulation etc.
- •use of pain drugs for other diseases (> 1x/week)
- •pregnancy
- •severe chronic or acute disease interfering with therapy attendance
- •alcohol or substance abuse
- •participation in another clinical trial in the last 6 months before study entry
研究组 & 干预措施
1
Experimental
qigong
干预措施: qigong (Procedure)
2
Active Comparator
exercise therapy
干预措施: exercise therapy (Procedure)
结局指标
主要结局
average pain intensity during the last 7 days measured on a visual analogue scale (VAS)
时间窗: baseline, 3, 6 and 12 months
次要结局
- disability (Roland-Morris-Questionnaire RMQ)(baseline, 3, 6 and 12 months)
- health related quality of life (SF 36)(baseline, 3, 6 and 12 months)
- credibility of the therapy for patients(baseline, 3, 6 and 12 months)
- patient expectation and self efficacy(baseline, 3, 6 and 12 months)
- therapist's expectation(baseline, 3, 6 and 12 months)
- sleep quality(baseline, 3, 6 and 12 months)
- undesired effects(baseline, 3, 6 and 12 months)
研究者
Claudia M. Witt
Prof. Dr. med.
Charite University, Berlin, Germany
研究点 (1)
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