Status:
COMPLETED
Efficacy and Safety Evaluation of Changes in Lower Extremity Edema of Radiofrequency
Lead Sponsor:
Pusan National University Yangsan Hospital
Conditions:
Idiopathic Edema
Eligibility:
FEMALE
19-72 years
Phase:
NA
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 occ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05185193
Start Date
June 30 2020
End Date
May 21 2021
Last Update
January 11 2022
Active Locations (1)
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1
Pusan national university Yangsan Hospital
Gyeongsang, Yangsan, South Korea, 50610