Efficacy and Safety Evaluation of Changes in Lower Extremity Edema of Radiofrequency

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy and Safety Evaluation of Changes in Lower Extremity Edema of Radiofrequency in Adult Women With Idiopathic Edema: Blinded, Cross-over, Pilot Study

Conditions
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Idiopathic Edema

Intervention / Treatment
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* Device: radiofrequency
* Device: sham stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: radiofrequency stimulation<br>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). | Device: radiofrequency<br>* Radiofrequency of 9.50v, 218.5mA and 2.076W is applied once a day for 30 minutes, a total of 3 times<br>* Other names: high frequency;|
| Sham Comparator: sham stimulation<br>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). | Device: sham stimulation<br>* The appearance is the same as the medical device for clinical trials, and when applied, the sound and the amount of light visible from the outside are designed to be the same as the medical device for clinical trials. The external light was the same, and only the high frequency that stimulates the dermis was blocked. The sham device was applied once a day for 30 minutes, a total of 3 times.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Circumference was measured using a tape measure at three anatomical locations. | Changes of circumference before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Volume | The leg volume test is measured using Volumeters (Deluxe Foot) of Jeongdo BNP Co., Ltd. in Korea. Measure using the principle of overflowing, fill a cylinder with a diameter of 30cm and a height of 30cm with water, put one leg in the cylinder with the ankle bent at 90 degrees, and take the overflowing water and measure the amount in ml. | Changes of volume before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group | 
| digital infrared thermal imaging(DITI) | Measure the subject's leg body heat using DITI. | Changes of body heat before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group | 
| Visual analog scale(VAS) | Discomfort VAS is used to measure the degree of discomfort for lower extremity edema after application of the device. And 0 indicates no discomfort at all, and 10 indicates the most severe discomfort imaginable. | Changes of VAS score before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group | 
| weight | Measure the participant's weight (kg) using a scale. | Changes of weight before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group |