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

Not Applicable

Completed

• Conditions: Idiopathic Edema
• Interventions: Device: sham stimulation; Device: radiofrequency

• Registration Number: NCT05185193
• Lead Sponsor: Pusan National University Yangsan Hospital

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.

Study Timeline

• Study Start: 2020-06-30
• Primary Completion: 2021-04-21
• Study Completion: 2021-05-21
• Study First Submitted: 2021-06-09
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-06
• Last Update Submitted: 2022-01-06
• Study First Posted: 2022-01-11
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

1. Women between the ages of 19 and 72
2. 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)
3. Those who meet the diagnostic criteria for idiopathic edema (McKendry criteria score of 15 or higher)
4. Those who show a weight change of 1.4 kg or more between morning and night measurements
5. 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
6. Those who voluntarily agree to participate in this clinical trial and sign the consent form

Exclusion Criteria

1. In the case of using a heart rate control device such as a metallic substance in the human body
2. During menstruation or if there is a possibility of pregnancy
3. If you have heart disease
4. If you have liver or kidney disease
5. If there is bleeding or internal bleeding from wounds or surgery
6. For hypertensive patients
7. For epilepsy patients
8. If you are taking weight loss or health-related drugs/health functional foods
9. In the case where it is judged by the principal investigator that participation in this study is not appropriate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
sham stimulation	sham stimulation	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).
radiofrequency stimulation	radiofrequency	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).

Primary Outcome Measures

Name	Time	Method
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)	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 Outcome Measures

Name	Time	Method
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	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.
weight	Changes of weight before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group	Measure the participant's weight (kg) using a scale.
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	Measure the subject's leg body heat using DITI.
Change of Volume	Changes of volume before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group	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.

Trial Locations

Locations (1)

Pusan national university Yangsan Hospital; 🇰🇷 Gyeongsang, Yangsan, Korea, Republic of