Efficacy and Safety Study of Individualized and Standardized Acupuncture Treatment for Low Back Pain
2012年4月5日 更新者：Dongwoo Nam
Clinical Trial to Evaluate and Compare the Efficacy and Safety of Individualized and Standardized Acupuncture for Low Back Pain Patients: Randomized, Double-blind, Controlled Study
The purpose of this study is to determine whether acupuncture treatment(Individualized & Standardized Acupuncture) is more effective than control (sham acupuncture or no treatment) and also whether individualized acupuncture is more effective than standardized acupuncture.
研究概览
详细说明
To determine whether individualized acupuncture is more effective than standardized acupuncture, 276 Low Back Pain patients will be recruited and randomly assigned to 4 separate groups.
Experimental groups(Individualized Acupuncture Group and Standardized Acupuncture Group) and Control groups (Sham acupuncture and waiting list)
The change of pain and physical functions will be compared among the four groups.
So the efficacy of acupuncture, and the best acupuncture treatment model will be determined. Also in addition, safety and abnormal reactions of acupuncture treatments will be evaluated.
研究类型
介入性
注册 (预期的)
276
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Seoul、大韩民国、130-872
- 招聘中
- Kyung Hee University Oriental Medicine Hospital
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接触：
- Dongwoo Nam, Ph.D
- 电话号码：+82-2-958-1827
- 邮箱：hanisanam@hanmail.net
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副研究员：
- Dongwoo Nam, Ph.D
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male and female patients suffering Low Back Pain.
- Patients classified as Class 1(pain in the lumbar area, without radiation below the gluteal fold and in the absence of neurologic signs) or Class 2(Low back pain with radiation of pain not beyond the knee, no neurological signs) according to the Quebec Task Force System
- Suffering pain which is more than 40mm on VAS(Visual Analog Scale)
- Voluntary participants who have completed the consent.
Exclusion Criteria:
- Low back trauma history within 6 months.
- Low back surgery history within 6 months.
- Low back pain caused by malignancy, inflammatory disease, fibromyalgia, vertebral fracture, infection, juvenile scoliosis or congenital malformation.
- Pain in other parts of the body more severe than low back pain.
- Mental problems that can influence the pain or results of questionnaire.
- Diseases that can interfere absorption, metabolism and excretion of medicine.
- History of alcohol or drug abuse within 12 months of the study.
- Pregnant, breastfeeding or childbearing aged women who are not using any birth control methods.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Individualized Acupuncture
The patients in this group received individualized acupuncture prescribed by a certified Korean Medicine Doctor with more than 6 years of oriental medicine college education and 2 years of clinical experience.
The acupuncture formulas were composed based on the pattern diagnosis, which is an unique diagnosis system of Oriental Medicine.
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该治疗每周应用两次，每次 20 分钟，持续 6 周（12 次）
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实验性的：标准化针灸
本组患者接受由具有6年以上东方医学大学教育和2年临床经验的认证韩国医师使用相同穴位的标准化针灸治疗。
针灸方剂是根据随机对照试验的文献综述组成的。
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The treatment was applied twice a week for 20 minutes for 6 weeks(12sessions) 8 Acupuncture points, GV4, GV3, BL24(bilateral), BL25(bilateral) and GB30(bilateral) were used for all the patients assigned to this group.
Sterile Stainless Steel(25mm x 40mm) disposable acupuncture needles manufactured by Dong-Bang Acupuncture Co.(Korea) were used.
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假比较器：假针灸
非穿透性针灸装置，Park-sham 针灸，应用于患者。
针灸的外观相同，但针不穿透皮肤。
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The treatment was applied twice a week for 6 weeks(12sessions).
The sham acupuncture was applied on the 8 same acupuncture points as in the standardized acupuncture group, GV4, GV3, BL24(bilateral), BL25(bilateral) and GB30(bilateral).
Each session was 20 minutes long.
其他名称：
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无干预：等待
本组患者未采取任何干预措施。
每次访问仅进行评估。
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本组患者未采取任何干预措施。
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The change of 100mm pain Visual Analog Scale(VAS) after 6 weeks of treatment.
大体时间：at baseline and after 6 weeks of treatment.
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Visual analog scale (VAS) is a tool used to measure pain.
The patient is asked to indicate their perceived pain intensity along a 100 mm horizontal line, where '0' represents 'no pain' and '100', 'unbearable pain'.
The change of pain will be reported by comparing the mean VAS before treatment and after the 6 week trearment period.
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at baseline and after 6 weeks of treatment.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Roland - Morris Disability Questionnaire
大体时间：at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit
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Roland - Morris Disability Questionnaire (RMDQ) is scored by adding up the number of items checked by the patients, among the 24 items concerning various disablilities caused by low back pain.
The score can therefore vary from 0 to 24.
Higher the scores represent worse disabilities.
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at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit
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SF-36
大体时间：at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit
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The 36 questions yields an 8-scale health profile.
It is useful in monitoring the change in health related quality of life.
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at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit
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Adverse Events
大体时间：at 2nd(baseline), 3rd, 4th, 5th, 6th, 7th, 8th, 9th, 10th, 11th, 12th and 13th(end of study)
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Any unpredicted symptoms were checked at each follow up visit and if any, the symptom, time of occurrence, and length of duration were recorded and reported.
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at 2nd(baseline), 3rd, 4th, 5th, 6th, 7th, 8th, 9th, 10th, 11th, 12th and 13th(end of study)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 学习椅：Jae-Dong Lee, Ph.D、Kyunghee University Medical Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年10月1日
初级完成 (预期的)
2012年8月1日
研究完成 (预期的)
2012年12月1日
研究注册日期
首次提交
2012年3月26日
首先提交符合 QC 标准的
2012年4月1日
首次发布 (估计)
2012年4月4日
研究记录更新
最后更新发布 (估计)
2012年4月6日
上次提交的符合 QC 标准的更新
2012年4月5日
最后验证
2012年4月1日
更多信息
与本研究相关的术语
其他研究编号
- KOMCIRB-02-20101130-02
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