Efficacy and Safety Evaluation of Changes in Lower Extremity Edema of Radiofrequency in Adult Women With Idiopathic Edema: Blinded, Cross-over, Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change of Circumference(the lower calf at 7 cm proximal to the midpoint of the medial malleolus, behind the medial malleolus, and the dorsum of the foot)
研究概览
简要总结
The purpose of this study is to verify the efficacy and safety of the radiofrequency stimulation compared to the sham stimulation in reducing lower extremity edema in adult women with idiopathic edema.
详细描述
In this study, based on the characteristics of radiofrequency, it was hypothesized that radiofrequency could have an effect on the reduction of lower extremity edema and prevention of fatigue. The occurrence of edema is interpreted as a problem that blood circulation is not smooth due to increased inflow of body fluid, and therefore the degree of edema is also used as an indicator of blood circulation.
Therefore, in this study, based on the principle that radiofrequency promotes phosphorylation and blood circulation, the purpose of this study is to investigate whether radiofrequency treatment is effective in reducing edema of the lower extremities and changing body heat in the lower extremities compared to the gastric stimulation device through exploratory research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 72 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between the ages of 19 and 72
- •Those who are not likely to menstruate during the trial treatment period (3 days) (females within 8 to 18 days after the onset of menstruation)
- •Those who meet the diagnostic criteria for idiopathic edema (McKendry criteria score of 15 or higher)
- •Those who show a weight change of 1.4 kg or more between morning and night measurements
- •Those who have a difference of 1cm or more from the ankle or 2cm or more from the calf when measuring the circumference in the morning and evening
- •Those who voluntarily agree to participate in this clinical trial and sign the consent form
排除标准
- •In the case of using a heart rate control device such as a metallic substance in the human body
- •During menstruation or if there is a possibility of pregnancy
- •If you have heart disease
- •If you have liver or kidney disease
- •If there is bleeding or internal bleeding from wounds or surgery
- •For hypertensive patients
- •For epilepsy patients
- •If you are taking weight loss or health-related drugs/health functional foods
- •In the case where it is judged by the principal investigator that participation in this study is not appropriate
研究组 & 干预措施
radiofrequency stimulation
Participants received radiofrequency stimulation three times a day for 30 minutes once a day. After the end of the first session intervention, there was a washout period and the next intervention was started at a time point when the next menstruation was not likely (8-18 days after the onset of menstruation).
干预措施: radiofrequency (Device)
sham stimulation
Participants received a sham stimulation similar to a radiofrequency stimulation three times a day for 30 minutes once a day. After the end of the first session intervention, there was a washout period and the next intervention was started at a time point when the next menstruation was not likely (8-18 days after the onset of menstruation).
干预措施: sham stimulation (Device)
结局指标
主要结局
Change of Circumference(the lower calf at 7 cm proximal to the midpoint of the medial malleolus, behind the medial malleolus, and the dorsum of the foot)
时间窗: Changes of circumference before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group
Circumference was measured using a tape measure at three anatomical locations.
次要结局
- Visual analog scale(VAS)(Changes of VAS score before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group)
- weight(Changes of weight before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group)
- digital infrared thermal imaging(DITI)(Changes of body heat before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group)
- Change of Volume(Changes of volume before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group)
研究者
Yong-il Shin
Professor
Pusan National University Yangsan Hospital