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

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

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 Type

Interventional


Primary Outcome

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)

Secondary Outcome

 Change of Volume

Condition

Idiopathic Edema

Intervention

radiofrequency

Study Arms / Comparison Groups

 radiofrequency stimulation
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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

15

Start Date

June 30, 2020

Completion Date

May 21, 2021

Primary Completion Date

April 21, 2021

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
      

Gender

Female

Ages

19 Years - 72 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Young-Il Shin, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT05185193

Organization ID

03-2020-001


Responsible Party

Principal Investigator

Study Sponsor

Pusan National University Yangsan Hospital


Study Sponsor

Young-Il Shin, Principal Investigator, Pusan National University Yangsan Hospital


Verification Date

January 2022