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

Primary Purpose

Idiopathic Edema

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
radiofrequency
sham stimulation
Sponsored by
Pusan National University Yangsan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Edema

Eligibility Criteria

19 Years - 72 Years (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Pusan national university Yangsan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

radiofrequency stimulation

sham stimulation

Arm 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).

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).

Outcomes

Primary Outcome Measures

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)
Circumference was measured using a tape measure at three anatomical locations.

Secondary Outcome Measures

Change of Volume
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)
Measure the subject's leg body heat using DITI.
Visual analog scale(VAS)
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
Measure the participant's weight (kg) using a scale.

Full Information

First Posted
June 9, 2021
Last Updated
January 6, 2022
Sponsor
Pusan National University Yangsan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05185193
Brief Title
Efficacy and Safety Evaluation of Changes in Lower Extremity Edema of Radiofrequency
Official Title
Efficacy and Safety Evaluation of Changes in Lower Extremity Edema of Radiofrequency in Adult Women With Idiopathic Edema: Blinded, Cross-over, Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 30, 2020 (Actual)
Primary Completion Date
April 21, 2021 (Actual)
Study Completion Date
May 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
radiofrequency stimulation
Arm Type
Experimental
Arm 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).
Arm Title
sham stimulation
Arm Type
Sham Comparator
Arm 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).
Intervention Type
Device
Intervention Name(s)
radiofrequency
Other Intervention Name(s)
high frequency
Intervention Description
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
Intervention Name(s)
sham stimulation
Intervention Description
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 Outcome Measure Information:
Title
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)
Description
Circumference was measured using a tape measure at three anatomical locations.
Time Frame
Changes of circumference before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group
Secondary Outcome Measure Information:
Title
Change of Volume
Description
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.
Time Frame
Changes of volume before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group
Title
digital infrared thermal imaging(DITI)
Description
Measure the subject's leg body heat using DITI.
Time Frame
Changes of body heat before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group
Title
Visual analog scale(VAS)
Description
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.
Time Frame
Changes of VAS score before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group
Title
weight
Description
Measure the participant's weight (kg) using a scale.
Time Frame
Changes of weight before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Il Shin
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan national university Yangsan Hospital
City
Gyeongsang
State/Province
Yangsan
ZIP/Postal Code
50610
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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