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
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 276
- 试验地点
- 2
- 主要终点
- The change of 100mm pain Visual Analog Scale(VAS) after 6 weeks of treatment.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The change of 100mm pain Visual Analog Scale(VAS) after 6 weeks of treatment.
时间窗: at baseline and after 6 weeks of treatment.
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.
次要结局
- Roland - Morris Disability Questionnaire(at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit)
- SF-36(at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit)
- Adverse Events(at 2nd(baseline), 3rd, 4th, 5th, 6th, 7th, 8th, 9th, 10th, 11th, 12th and 13th(end of study))
研究者
Dongwoo Nam
Assistant Professor
Kyunghee University Medical Center