Efficacy and Safety Evaluation of Changes in Lower Extremity Edema of Radiofrequency in Adult Women With Idiopathic Edema: Blinded, Cross-over, Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Idiopathic Edema
- Sponsor
- Pusan National University Yangsan Hospital
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- 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)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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.
Investigators
Yong-il Shin
Professor
Pusan National University Yangsan Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
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)
Time Frame: 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.
Secondary Outcomes
- 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)