此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Clinical Study to Evaluate the Safety and Efficacy of Heating and Cooling Combination Therapeutic Device(OCH-S100)

2014年11月9日 更新者：Eun Jung Kim

A Randomized, Double-blind, Multicenter, Parallel Designed Clinical Study to Evaluate the Safety and Efficacy of Heating and Cooling Combination Therapeutic Device(OCH-S100) in Patients With Chronic Low Back Pain

The purpose of this study is to verify the efficacy and safety of heating and cooling combination therapeutic device (OCH-S100) for patients with chronic low back pain (LBP).

研究概览

地位

未知

条件

干预/治疗

详细说明

The investigators targeted the patients with chronic LBP. After treatment in 2 groups - real heating and cooling combination treatment and sham heating and cooling combination treatment - the investigators will compare the effects of pain relief and improvement in disability and range of motion of lumbar region. So the investigators will confirm the efficacy of heating and cooling combination therapy, and further the best treatment method. In addition, the investigators are going to evaluate the safety of abnormal reaction during the treatment.

研究类型

介入性

注册 (预期的)

80

阶段

  • 不适用

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

  • 大韩民国
    • Gyeonggi-do
      • Seongnam、Gyeonggi-do、大韩民国、463-865
        • 招聘中
        • Donnguk University Oriental Medical Hospital
        • 接触：

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

20年 至 75年 (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:

  1. At least 20 years of age, but below 75 years of age
  2. Low back pain in the last 3 months or more
  3. Low back pain rated over 40 mm on a 100 mm Visual Analog Scale (VAS)
  4. Those who are reliable and willing to cooperate in this test, and obey the restrictions for the treatment period.
  5. An understanding of the objectives, methods and efficacy of the clinical trial, and willingness in completing the consent form.

Exclusion Criteria:

  1. Trauma to or surgery on the lumbar region within 6 months prior to enrollment
  2. Low back pain accompanied by sciatica
  3. Systematic disease, and severe dysfunction due to the medical illness (e.g. cancer, infection, etc.)
  4. A history of medication, oriental medical treatment, physiotherapy for treating low back pain within the last 4 weeks
  5. Neurological disease, such as topical or whole body hypoesthesia in temperature sensation (e.g. stroke, peripheral neuropathy, etc.)
  6. Hypersensitivity in heating and cooling stimulation
  7. Pregnant and lactating women
  8. Participate in the other clinical trials within the last 3 months or after enroll this trial
  9. When researchers evaluate that it is not appropriate to participate in this clinical test

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
实验性的：Heating and cooling combination therapy
The patients in this group received heating and cooling combination therapy by a certified Korean Medicine Doctor with more than 6 years of oriental medicine college education and 2 years of clinical experience. Doctor press 8 acupuncture points which is treated in LBP patients and select the most painful 2 acupuncture points. Device's probe is attached to the acupuncture points in 15 minutes. Probe's temperature is changed 5 cycles from maximum 45℃ to minimum 15℃.
设备：Heating and cooling combination therapy
The treatment was applied 10 times for 4 weeks. Most painful 2 points in 8 acupuncture points(both side of Bladder meridian23 (BL23), BL24, BL25, BL26) were used for all the patients assigned to this group.
其他名称：
  • OCH-S100
假比较器：Sham heating and cooling therapy
The patients in this group received sham heating and cooling combination therapy in same conditions of treatment group except the temperature. Before the treatment begin, caregiver measure the patient's skin temperature. Then probe's temperature is changed 5 cycles from 1℃ over the skin temperature to 1℃ under the skin temperature.
设备：Sham heating and cooling therapy
The treatment was applied 10 times for 4 weeks. The sham heating and cooling combination therapy was applied on the 2 of 8 same acupuncture points as in the treatment group.
其他名称：
  • OCH-S100

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
Change from baseline in 100mm Pain Visual Analogue Scale (VAS)
大体时间：at baseline and 4 4 weeks later from baseline
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'
at baseline and 4 4 weeks later from baseline

次要结果测量

结果测量
措施说明
大体时间
Change from baseline in 100mm Pain Visual Analogue Scale (VAS)
大体时间：estimately every 2.8 days from baseline to 4 weeks later, and 4 weeks later from the end of treatment
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'
estimately every 2.8 days from baseline to 4 weeks later, and 4 weeks later from the end of treatment
Change from baseline in Korean Oswestry disability index (KODI)
大体时间：at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
KODI is checked by the patients. KODI is a questionnaire to measure the back-related disability. KODI consists of combination of physical and social restriction through 9 questions covering different dimensions of daily living.
at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
Change from baseline in Korean Roland Morris Disability Questionnaire (KRMDQ)
大体时间：at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
KRMDQ is checked by the patients. KRMDQ is a questionnaire to measure the back-related disability. KRMDQ consists of 24 questions answered yes or no.
at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
Change from baseline in Traditional Medicine Back pain Questionnaire (TMBQ)
大体时间：at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
TMBQ is checked by the patients. TMBQ is a questionnaire to measure the back-related disability in aspect of oriental medicine.
at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
Change from baseline in Modified schöber test
大体时间：at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
Modified schöber test measures the flexion range of motion of lumbar spine. First, investigator marks the point at patients' lumbosacral junction. Then also marks the points at upper 10cm and lower 5cm of the former point in standing position. After marking the 3 points, patients bend anteriorly as best he or she can. Then, investigator measures the length of the latter 2 points.
at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
Change from baseline in Finger-to-floor distance
大体时间：at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
Finger-to-floor distance measures the flexion range of motion of lumbar spine. Patients stand on the box which height is 20cm. Then, patients bend anteriorly in extension of knee and upper limb. Investigator measures the length from floor to 3rd finger.
at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
Change from baseline in Finger-to-thigh distraction
大体时间：at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
Finger-to-thigh distraction measures the lateral bending range of motion of lumbar spine. Patients stand on the box which height is 20cm. Then, patients bend laterally in extension of knee and upper limb. Investigator measures the length from floor to 3rd finger.
at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
Adverse Events
大体时间：estimately every 2.8 days from baseline to 4 weeks later, and 4 weeks later from the end of treatment
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.
estimately every 2.8 days from baseline to 4 weeks later, and 4 weeks later from the end of treatment

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

Eun Jung Kim

合作者

Ministry of Health & Welfare, Korea

调查人员

  • 首席研究员：Seung Deok Lee, Ph.D.、Donnguk University Oriental Medical center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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

2014年9月1日

初级完成 (预期的)

2015年9月1日

研究完成 (预期的)

2015年9月1日

研究注册日期

首次提交

2014年10月14日

首先提交符合 QC 标准的

2014年11月9日

首次发布 (估计)

2014年11月13日

研究记录更新

最后更新发布 (估计)

2014年11月13日

上次提交的符合 QC 标准的更新

2014年11月9日

最后验证

2014年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • OCH-S100-2014
  • HI11C2135 (其他赠款/资助编号：The Korea Health Industry Development Institute)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅