NCT01491321Unknown2 期
Clinical Trial to Evaluate the Efficacy of Bee Venom Acupuncture on Chronic Low Back Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale for bothersomeness
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of bee venom acupuncture on pain intensity, functional status and quality of life of patients with chronic low back pain.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •nonspecific, chronic low back pain over 3 months
- •Must have LBP of more than VAS 4
排除标准
- •cancer, vertebral fracture, spinal infection, inflammatory spondylitis
- •spinal operation
- •radicular pain
- •other musculoskeletal pain
- •physicological or mental disorders
- •allergic history to BV therapy or insect bite
研究组 & 干预措施
Bee Venom Acupuncture & Loxoprofen
Experimental
干预措施: Bee Venom Acupuncture Therapy (Procedure)
Bee Venom Acupuncture & Loxoprofen
Experimental
干预措施: Loxoprofen (Drug)
Sham Bee Venom Acupuncture & Loxoprofen
Placebo Comparator
干预措施: Loxoprofen (Drug)
Sham Bee Venom Acupuncture & Loxoprofen
Placebo Comparator
干预措施: Placebo (Procedure)
结局指标
主要结局
Visual Analogue Scale for bothersomeness
时间窗: Changes from baseline in VAS at 1 month
次要结局
- Visual Analogue Scale for pain intensity(Changes from baseline in VAS at 1 month)
- Disability scores on Oswestry Disability Index(Changes from baseline in ODI at 1 month)
- Quality of Life scores on EQ-5D(Changes from baseline in EQ-5D at 1 month)
- Depression scores on Beck Depression Inventory(Changes from baseline in BDI at 1 month)
研究者
JLee
Clinical Assistant Professor
Kyunghee University Medical Center
研究点 (1)
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