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

Pusan National University Yangsan Hospital

Status: Completed

Conditions: Idiopathic Edema

Treatments: Device: radiofrequency; Device: sham stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05185193

03-2020-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: Female

Ages: 19 to 72 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 2 patient groups

radiofrequency stimulation

Experimental group

Description:

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).

Treatment:

Device: radiofrequency

sham stimulation

Sham Comparator group

Description:

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).

Treatment:

Device: sham stimulation