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

NCT ID: NCT05185193

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2021-05-21

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.

Conditions

Idiopathic Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

radiofrequency stimulation

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).

Group Type: EXPERIMENTAL

radiofrequency

Intervention Type: DEVICE

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

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).

Group Type: SHAM_COMPARATOR

sham stimulation

Intervention Type: 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.

Interventions

radiofrequency

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

Intervention Type: DEVICE

sham stimulation

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.

Intervention Type: DEVICE

Other Intervention Names

high frequency

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pusan National University Yangsan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yong-il Shin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Young-Il Shin

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Yangsan Hospital

Locations

Pusan national university Yangsan Hospital

Gyeongsang, Yangsan, South Korea

Countries

South Korea

Other Identifiers

03-2020-001

Identifier Type: -

Identifier Source: org_study_id