Changes in Skin Surface Temperature of the Lumbar Region During Auricular Acupressure at Kidney Point on Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change in temperature of the right lumbar region
研究概览
简要总结
In Traditional Medicine, auricular acupressure (AA) is one of the non-pharmacological treatment methods commonly utilized due to its safety and convenience. AA involves the application of a taped seed of Vaccaria (with a diameter of 2mm) on specific ear acupoints to manage various disorders. Among these, chronic lower back pain is prevalent. According to Traditional Medicine, the Kidney point is selected for this condition due to the belief that "The lumbar region is the house of the Kidneys". However, evidence supporting this correlation is still lacking. In this study, the aim is to assess the relationship between the Kidney point and the lumbar region by monitoring changes in skin temperature through the application of AA on this acupoint.
详细描述
Healthy volunteers meeting all selection criteria and not violating exclusion criteria will be recruited for the study.
Before commencement, participants will acclimate to the environment for 15 minutes, allowing stabilization of blood pressure, heart rate, respiratory rate, and body temperature. The room will be enclosed and shielded, ensuring no direct sunlight or other radiation sources enter. Room temperature, pressure, humidity, and ventilation will be consistently maintained throughout the study.
The participants will be randomly divided into two groups: one receiving auricular acupressure (AA) first followed by sham auricular acupressure (SA) (AA-SA group), while the other group will receive SA first followed by AA (SA-AA group).
Blood pressure, heart rate, respiratory rate, body temperature, lumbar region temperature, and side effects of auricular therapies will be continuously monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •BMI between 18.5 and 23 kg/m
- •Demonstrates alertness and cooperativeness.
- •Vital signs within normal limits.
- •Voluntary informed consent.
排除标准
- •Anxiety, depression, or stress based on the Depression Anxiety and Stress Scales 21 (DASS-21).
- •Presence of disorders or use of medications affecting body temperature.
- •Received any form of heat therapy for the lower back within the past week (e.g., acupuncture, heat pads, patches, massage).
- •Applied chemical or pharmaceutical products to the skin area under investigation prior to the study.
- •Current disorders or pathologies in the lumbar region.
- •Engaged in nighttime activities or experienced insomnia the night before the research day.
- •Participated in sports activities within 2 hours before the study.
- •Used stimulants within 24 hours prior.
- •History of alcohol or substance addiction.
- •History of hypersensitivity reactions to any form of acupuncture.
- •Existing injuries or lesions at acupoints and areas investigated in this study.
- •Women currently menstruating, pregnant, or breastfeeding.
- •Prior experience with auricular therapies.
- •Currently participating in other intervention studies.
结局指标
主要结局
Change in temperature of the right lumbar region
时间窗: During procedure
The temperature of the lumbar region is recorded using an infrared thermal imaging camera. The unit is degrees Celsius (°C).
Change in temperature of the left lumbar region
时间窗: During procedure
The temperature of the lumbar region is recorded using an infrared thermal imaging camera. The unit is degrees Celsius (°C).
次要结局
- The proportion of auricular acupuncture side effects(During procedure)
研究者
Bui Pham Minh Man
Investigator
University of Medicine and Pharmacy at Ho Chi Minh City