NCT05185193

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

Efficacy and Safety Evaluation of Changes in Lower Extremity Edema of Radiofrequency in Adult Women With Idiopathic Edema: Blinded, Cross-over, Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Pusan National University Yangsan Hospital · Academic / Other
• Sex: Female
• Age: 19 Years – 72 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	radiofrequency	Radiofrequency of 9.50v, 218.5mA and 2.076W is applied once a day for 30 minutes, a total of 3 times
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.

Timeline

• Start date: 2020-06-30
• Primary completion: 2021-04-21
• Completion: 2021-05-21
• First posted: 2022-01-11
• Last updated: 2022-01-11

Locations

1 site across 1 country: South Korea