An interventional study of radiofrequency and sham stimulation in Idiopathic Edema, sponsored by Pusan National University Yangsan Hospital. Completed at 1 site in Korea, Republic of. Open to female participants aged 19 Years to 72 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-11.
Sponsored by Pusan National University Yangsan Hospital · Not applicable, Interventional, and Treatment
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.
825 studies on the registry are indexed under Edema; 91 are open to participants now.
This study's enrollment of 15 is below the median of 52 across 601 interventional studies indexed under Edema.
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Exclusion Criteria:
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
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
Radiofrequency of 9.50v, 218.5mA and 2.076W is applied once a day for 30 minutes, a total of 3 times
Also known as: high frequency
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.
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.
Time frame: Changes of circumference before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Changes of weight before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group
Plan to share: No
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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Pusan National University Yangsan Hospital