Change in Skin Surface Temperature at the Neck When Using Acupuncture at Houxi Point in Healthy Volunteers: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The change in skin surface temperature at the neck when using acupuncture at Houxi point on each hand.
研究概览
简要总结
Acupuncture is a method of inserting very thin needles into special points on the body which are called acupoints, to treat diseases. This treatment has been widely applied in health care for over 2500 years. Currently, by synthesizing the results of many clinical studies, the World Health Organization (WHO) has recognized the importance of acupuncture as an effective treatment for various diseases. However, the specific effect of acupoints is still controversial. Until now, several studies have shown that acupoints are associated with certain areas of the human body that are far from the acupoints and can alter the temperature of those area. In our study, we will survey on the change in skin surface temperature at the neck when using acupuncture at Houxi point in healthy volunteers.
详细描述
Participants and Methods: A randomize controlled trial will be conducted by comparing the change in the skin surface temperature before and after using acupunture at the control acupoint (Yuji - LU10) and the research acupoint (Houxi - SI3) on either the left or right hand in healthy volunteers. A total of 60 participants will be randomly assigned to 2 group (A and B) and the allocation was 1:1. Both groups will undergo two trial phases 07 days apart, corresponding to one acupoint on the same hand in each step. Group A (acupoints on the left hand): participants will be received acupuncture at the control acupoint (Yuji - LU10) in the first trial phase, and the second phase will be conducted after 07 days at the research acupoint (Houxi - SI3). Group B: proceeding similarly to group A, but the points are on the right hand. The primary outcome will be the change in skin surface temperature at the neck when using acupuncture at Houxi point on each hand. This trial will be performed as a 2-arm parallel design, randomize, controlled and single blinded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females were individual age between enough 18 and 30 years old.
- •BMI: 18.5 - 23 kg/m2
- •Mental alertness, good contact, cooperation with researchers.
- •Having no psychiatric stress problem during acupuncture day (confirmed by answering the DASS21 questionnaire with stress point less than 15 points).
- •Vital sign within normal limits:
- •Heart rates from from 60 to 99 beats/minute.
- •Systolic blood pressure between 90 and 139 mmHg.
- •Diastolic blood pressure between 60 and 89 mmHg.
- •Body temperature: 36.59 ± 0.43 0C.
- •Breathing rate: 16 ± 3 respirations/minute .
- •Having no disease or using drugs that change the body temperature.
- •Not currently participating in other intervention studies.
- •Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials.
- •Having no acupuncture knowledge and experience yet.
排除标准
- •Playing sport 2 hours before the study.
- •Taking stimulant (alcohol, beer, coffee and tobacco) within 24 hours before conducting the study.
- •Staying up late at night or having insomnia before the day of the study.
- •Women who were in menstruation period, pregnancy, or breastfeeding.
- •Having skin injuries, dermatitis-skin infections or wounds in the area to be investigated.
- •Curently having neck-pain or other diseases that could affect or interfere with outcomes, including common cold.
- •Currently taking sedatives or drugs that cause vasodilation, affect blood pressure and heart rate.
- •Applying chemical or pharmaceutical products to the site of the skin to be investigated before conducting the study.
- •Using physical therapy, heat therapy, cupping therapy, massage, acupuncture in the site of the skin to be investigated within 24 hours.
- •Anxiety, depression, stress before conducting the study with DASS 21 score < 15.
结局指标
主要结局
The change in skin surface temperature at the neck when using acupuncture at Houxi point on each hand.
时间窗: During procedure
Survey the change in temperature at the neck area respectively when using acupuncture at the left and right research acupoints (Houxi - SI3) compared with the control acupoints group (Yuji - LU10).
时间窗: During procedure
次要结局
未报告次要终点
研究者
Bui Pham Minh Man
Medical Doctor
University of Medicine and Pharmacy at Ho Chi Minh City