Completed

NCT Number: NCT05185193

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

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.

Completed

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Key information

Conditions

Idiopathic Edema

Age range

19 year–72 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pusan national university Yangsan Hospital

Gyeongsang, Yangsan, 50610, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequency

Device

Radiofrequency of 9.50v, 218.5mA and 2.076W is applied once a day for 30 minutes, a total of 3 times

Other names: high frequency

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.

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

Change of Volume

Time frame: 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.
digital infrared thermal imaging(DITI)

Time frame: 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.
Visual analog scale(VAS)

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

Efficacy and Safety Evaluation of Changes in Lower Extremity Edema of Radiofrequency in Adult Women With Idiopathic Edema: Blinded, Cross-over, Pilot Study

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Jan 11, 2022
Registry last updated: Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.