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

NCT05185193 | Completed

• 1 other identifier: 03-2020-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Edema

Outcome Measures

Primary Outcomes (1)

• 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.

  Changes of circumference before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group

Secondary Outcomes (4)

• Change of Volume

  Changes of volume before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group

• digital infrared thermal imaging(DITI)

  Changes of body heat before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group

• Visual analog scale(VAS)

  Changes of VAS score before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group

• weight

  Changes of weight before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group

Study Arms (2)

radiofrequency stimulation

EXPERIMENTAL

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).

Device: radiofrequency

sham stimulation

SHAM COMPARATOR

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).

Device: sham stimulation

Interventions

radiofrequency DEVICE

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

Also known as: high frequency

radiofrequency stimulation

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.

sham stimulation

Eligibility Criteria

• Age: 19 Years - 72 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan national university Yangsan Hospital

Gyeongsang, Yangsan, 50610, South Korea

Location

Study Officials

• Young-Il Shin

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: January 11, 2022
• Study Start: June 30, 2020
• Primary Completion: April 21, 2021
• Study Completion: May 21, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)