The Effect of Acupuncture in Treating Chronic Low-back Pain
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Changes from baseline on modified Roland-Morris Disability Questionnaire (RMDQ) at 24 weeks
研究概览
简要总结
The purpose of this study is to evaluate the efficiency of acupuncture in treating chronic low-back pain
详细描述
We want to know if the Yaotong points penetration or standardized acupuncture mode are more effective than medical care alone for CLBP; and if Yaotong points penetration is more effective than standardized acupuncture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •with CLBP
- •without taking any other medication for the treatment of CLBP in at least 2 last weeks;
- •aged from 18 to 50 years;
- •without conflict to the written, informed consent signed prior to the enrollment.
排除标准
- •pathological causes of chronic back pain (such as fractures, cancer, spinal stenosis and infections);
- •complicated back problems (such as scoliologic >40° curvature, chronic spondylitis, sciatica, prior back surgery and other medicolegal issues);
- •with contraindications for acupuncture (e.g., cardiac pacemakers, coagulation disfunctions, being in pregnancy, seizure disorder);
- •conditions making treatment difficult (e.g., paralysis, psychoses);
- •conditions that might confound treatment effects or interpretation of results (e.g., severe fibromyalgia, rheumatoid arthritis, concurrent care from other providers);
- •previous acupuncture treatment for any condition.
研究组 & 干预措施
Yaotong points acupuncture
patients under the treatment of Yaotong ponts penetration mode
干预措施: Yaotong points acupuncture (Other)
standardized acupuncture
patients under the treatment of standardized acupuncture
干预措施: standardized acupuncture (Other)
the usual care
In the usual care group, participants received no study-related care-just the care, if any, that they and their physicians chose: mostly massage and physical therapy visits and continued use of medications (mostly nonsteroidal anti-inflammatory drugs (NSAIDS)).
干预措施: the usual care (Other)
结局指标
主要结局
Changes from baseline on modified Roland-Morris Disability Questionnaire (RMDQ) at 24 weeks
时间窗: at 0 week, 12 weeks, 24 weeks
This wellvalidated questionnaire assesses pain on several dimensions including sensory pain, affective pain, and evaluative pain.
次要结局
- Changes from baseline on Diagnosis and Curative Effect Standard for Syndrome of TCM for CLBP at 24 weeks(at 0 week, 12 weeks, 24 weeks)
- Changes from baseline on short-form 36 health survey (SF-36)(at 0 week, 12 weeks, 24 weeks)
- Changes from baseline on Visual Analog Scale at 24 weeks(at 0 week, 12 weeks, 24 weeks)
研究者
Yang Min
Ph.D
Chengdu PLA General Hospital