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
试验速览
- 阶段
- 不适用
- 发起方
- Eun Jung Kim
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change from baseline in 100mm Pain Visual Analogue Scale (VAS)
研究概览
简要总结
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).
详细描述
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 20 years of age, but below 75 years of age
- •Low back pain in the last 3 months or more
- •Low back pain rated over 40 mm on a 100 mm Visual Analog Scale (VAS)
- •Those who are reliable and willing to cooperate in this test, and obey the restrictions for the treatment period.
- •An understanding of the objectives, methods and efficacy of the clinical trial, and willingness in completing the consent form.
排除标准
- •Trauma to or surgery on the lumbar region within 6 months prior to enrollment
- •Low back pain accompanied by sciatica
- •Systematic disease, and severe dysfunction due to the medical illness (e.g. cancer, infection, etc.)
- •A history of medication, oriental medical treatment, physiotherapy for treating low back pain within the last 4 weeks
- •Neurological disease, such as topical or whole body hypoesthesia in temperature sensation (e.g. stroke, peripheral neuropathy, etc.)
- •Hypersensitivity in heating and cooling stimulation
- •Pregnant and lactating women
- •Participate in the other clinical trials within the last 3 months or after enroll this trial
- •When researchers evaluate that it is not appropriate to participate in this clinical test
研究组 & 干预措施
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℃.
干预措施: Heating and cooling combination therapy (Device)
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.
干预措施: Sham heating and cooling therapy (Device)
结局指标
主要结局
Change from baseline in 100mm Pain Visual Analogue Scale (VAS)
时间窗: 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'
次要结局
- Change from baseline in 100mm Pain Visual Analogue Scale (VAS)(estimately every 2.8 days from baseline to 4 weeks later, and 4 weeks later from the end of treatment)
- Change from baseline in Traditional Medicine Back pain Questionnaire (TMBQ)(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(at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment)
- Change from baseline in Korean Oswestry disability index (KODI)(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)(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(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(at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment)
- Adverse Events(estimately every 2.8 days from baseline to 4 weeks later, and 4 weeks later from the end of treatment)
研究者
Eun Jung Kim
Clinical trial Chief of Research
DongGuk University