Idiopathic EdemaNCT05185193
Efficacy and Safety Evaluation of Changes in Lower Extremity Edema of Radiofrequency
A study testing radiofrequency in people with Idiopathic Edema, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 72 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Edema
- What is being tested?
- radiofrequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jun 2020to 21 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 72 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan national university Yangsan Hospital
Gyeongsang, Yangsan, 50610
About this study
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
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.
Read the 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
- Being tested
- radiofrequency, sham stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequencyDevice
Also called high frequency
Radiofrequency of 9.50v, 218.5mA and 2.076W is applied once a day for 30 minutes, a total of 3 times
sham stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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)
Measure the subject's leg body heat using DITI.
Measured: 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)
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.
Measured: Changes of VAS score before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group
weight
Measure the participant's weight (kg) using a scale.
Measured: Changes of weight before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start30 Jun 2020
- Primary completion21 Apr 2021
- Study completion21 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong-il Shin, Pusan National University Yangsan Hospital
- Investigators
- Young-Il Shin, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185193
- Sponsor's protocol ID
- 03-2020-001
- Status last verified
- Jan 2022
- First submitted
- 9 Jun 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05185193
- Acronym / sponsor ID
- 03-2020-001
- Conditions
- Idiopathic Edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 21 Apr 2021 (actual)
- Study completion
- 21 May 2021 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiofrequency stimulation | Experimental | Device: radiofrequencyParticipants 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). |
| sham stimulation | Sham comparator | Device: sham stimulationParticipants 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). |
Who may qualify
- Ages
- 19 to 72 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiofrequencyAlso: high frequencyRadiofrequency of 9.50v, 218.5mA and 2.076W is applied once a day for 30 minutes, a total of 3 times | Device | radiofrequency stimulation |
| sham stimulationThe 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. | Device | sham stimulation |
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)
Time frame: Changes of circumference before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group
Circumference was measured using a tape measure at three anatomical locations.
4 secondary outcomes
Change of Volume
Time frame: 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)
Time frame: 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)
Time frame: Changes of VAS score before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group
weight
Time frame: Changes of weight before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young-Il Shin principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiofrequency in people with Idiopathic Edema, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Changes of circumference before and immediately after 30 minutes radiofrequency stimulation on once a day basis in the experimental group). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.