NCT00615732已完成不适用
Prospective, Randomized Controlled Trial on the Effectiveness of Qigong and Exercise Therapy in Patients With Chronic Neck Pain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 2
- 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 chronic neck pain compared to exercise therapy and waiting list group.
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 neck pain since at least 6 months and complaints for a maximum duration of 5 years
- •neck 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)
- •normal mobility of the cervical spine
- •intellectual and physical ability to participate in the study
- •informed consent
排除标准
- •cervical pain related to malignancy
- •cervical 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 neck pain - such as swimming, yoga, pilates, tai chi, 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
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, 12, and 24 months
次要结局
- Neck Pain and Disability Scale (NPAD, Wheeler 1999)(baseline, 3, 6, 12, and 24 months)
- health related quality of life (SF-36)(baseline, 3, 6, 12 and 24 months)
- patient expectation and self efficacy (questionnaire)(Baseline, 3, 6, 12, and 24 months)
- therapist's expectation(baseline, 3, 6, 12, and 24 months)
- undesired effects(3, 6, 12, and 24 months)
- semi-structured interviews to detect changes due to therapy and to assess the used questionnaires(3 and 6 months)
研究者
Claudia M. Witt
Prof. Dr. med.
Charite University, Berlin, Germany
研究点 (2)
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