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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| radiofrequency stimulation | Experimental | 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). |
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| sham stimulation | Sham Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiofrequency | Device | Radiofrequency of 9.50v, 218.5mA and 2.076W is applied once a day for 30 minutes, a total of 3 times |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young-Il Shin | Pusan National University Yangsan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan national university Yangsan Hospital | Gyeongsang | Yangsan | 50610 | South Korea |
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| sham stimulation | Device | 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. |
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| 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 |