NCT00925951已完成不适用
The Effectiveness of Wet Cupping on Persistent Non-specific Low Back Pain: A Randomized, Waiting-list Controlled, Open-label, Parallel-group Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Numeric Rating Scale (NRS) for pain
研究概览
简要总结
The hypothesis of this study is that the improvement of Numeric Rating Scale (NRS) for Pain at the end of the study will be greater in the Wet Cupping Treatment group than in the Waiting Control 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
- •Patients who have had non-specific low back pains at least 12 weeks now.
排除标准
- •Patients who have low back pain due to specific and known etiological causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome, cauda equinal syndrome).
- •Patients who are inappropriate to the wet cupping treatment.
- •AIDS, Active Hepatitis, Tuberculosis, Syphilis
- •Patients who regularly take anticoagulants, antiplatelet drugs
- •Anemia, thrombocytopenia
- •Hemorrhagic disease like hemophilia
- •Severe cardiovascular disease
- •Kidney diseases (renal failure, chronic renal disease)
- •Patients who have experiences of wet cupping treatment during last 3 months.
- •Patients who have had treatment for low back pain during last 2 weeks.
- •Patients who are in pregnancy or have plan to conception.
- •Patients who have vertebra surgery or have plan of surgery.
- •Patients who are inappropriate to join this trial judged by the radiologists or specialists.
研究组 & 干预措施
Wet Cupping
Experimental
干预措施: Wet Cupping (Device)
Wet Cupping
Experimental
干预措施: Acetaminophen (Drug)
Waiting Control
No Intervention
They can't use any other specific treatment except exercises and behavior modification (we'll offer a brochure which includes exercise method and directions about behavior modifications).
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Numeric Rating Scale (NRS) for pain
时间窗: study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation
次要结局
- Medication Quantification Scale (MQS)(study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation)
- Present Pain Intensity Scale of the McGill Pain Questionaire (PPI)(study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation)
- General Assessment of Doctors and Subjects(study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation)
- Safety measurement(study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation)
- Oswestry Disability Questionnaire (ODQ)(study group: at base line, post-treatment, 4 weeks later after allocation; control group: at base line, 4 weeks later after allocation)
研究者
研究点 (1)
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