Clinical trial NCT05185193: 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
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Edema
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 15
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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)
timeFrame: Changes of circumference before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group
Secondary outcomes:
measure: Change of Volume
timeFrame: Changes of volume before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group
measure: digital infrared thermal imaging(DITI)
timeFrame: Changes of body heat before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group
measure: Visual analog scale(VAS)
timeFrame: Changes of VAS score before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group
measure: weight
timeFrame: Changes of weight before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group
Other outcomes:
Locations:
city: Gyeongsang
country: Korea, Republic of
facility: Pusan national university Yangsan Hospital
state: Yangsan
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Young-Il Shin
role: PRINCIPAL_INVESTIGATOR
References: