Primary DysmenorrheaNCT04937270
Effects of High-frequency Deep Diathermy on Heart Rate Variability in Women With Primary Dysmenorrhea
A study testing High frequency therapy (5 minutes), High frequency therapy (7 minutes) and High frequency therapy (9 minutes) in people with Primary Dysmenorrhea and Dysmucorrhea, run by Sahmyook University at 1 site in South Korea.
Trial summary
Superficial heat therapy is mainly used to relieve menstrual pain, but it does not penetrate deeper than the skin tissue. In order to penetrate deep into the deep layers and promote tissue relaxation, deep heat therapy can be effective. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea, Dysmucorrhea
- What is being tested?
- High frequency therapy (5 minutes), High frequency therapy (7 minutes) and High frequency therapy (9 minutes)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Jun 2021to 30 Nov 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between the ages of 18-50
- Regular menstrual cycle (24-32 days)
- Those who have had symptoms of primary dysmenorrhea for at least 1 year
- Those who have lower back pain symptoms related to menstrual pain of 5 or higher on the Visual Analysis Scale (VAS)
- The body mass index is between 20-30
Who cannot join
- pelvic inflammatory disease
- uterine fibroids, polycystic ovary syndrome. Those with gynecological findings such as endometriosis
- Those who have used an intrauterine contraceptive device
- Those who took birth control pills or nonsteroidal anti-inflammatory drugs at the time of the experiment
Trial locations and contacts
1 site in 1 country.
About this study
Superficial heat therapy is mainly used to relieve menstrual pain, but it does not penetrate deeper than the skin tissue. In order to penetrate deep into the deep layers and promote tissue relaxation, deep heat therapy can be effective. The treatment time for deep heat treatment is controversial, and there is no study on deep heat treatment using radio frequency for dysmenorrhea. Therefore, in this study, by applying radiofrequency waves at different times to the lower abdomen for patients with primary dysmenorrhea, the pain and changes in the autonomic nervous system were compared with thermotherapy to suggest appropriate therapeutic interventions.
- Conditions
- Primary Dysmenorrhea, Dysmucorrhea
- Being tested
- High frequency therapy (5 minutes), High frequency therapy (7 minutes), High frequency therapy (9 minutes), Superficial heat therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High frequency therapy (5 minutes)Device
The high-frequency therapy device (radio frequency therapy, WINBACK, Villeneuve Loubet France) used in this study was used to treat deep heat for 5 minutes using a 500 kHz resistive electric transfer (RET).
High frequency therapy (7 minutes)Device
The high-frequency therapy device (radio frequency therapy, WINBACK, Villeneuve Loubet France) used in this study was used to treat deep heat for 7 minutes using a 500 kHz resistive electric transfer (RET).
High frequency therapy (9 minutes)Device
The high-frequency therapy device (radio frequency therapy, WINBACK, Villeneuve Loubet France) used in this study was used to treat deep heat for 9 minutes using a 500 kHz resistive electric transfer (RET).
Superficial heat therapyDevice
In the physical therapy used in this study, it was applied for 20 minutes using conventionally used superficial heat therapy.
| Study group | Role | What they receive |
|---|---|---|
| High frequency application time is 5 minutes | Experimental | The group which treats for 5 minutes by using the high-frequency therapy device Receives: Device: High frequency therapy (5 minutes) |
| High frequency application time is 7 minutes | Experimental | The group which treats for 7 minutes by using the high-frequency therapy device Receives: Device: High frequency therapy (7 minutes) |
| High frequency application time is 9 minutes | Experimental | The group which treats for 9 minutes by using the high-frequency therapy device Receives: Device: High frequency therapy (9 minutes) |
| Superficial heat therapy | Active comparator | Group treated with superficial heat therapy for 20 minutes Receives: Device: Superficial heat therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability
Autonomic nervous system balance tester (SA3000new, Medicore Co. Korea) was used. The subjects placed electrodes on three areas (left arm, left leg, right leg) while lying down and performed for 3 minutes.
Measured: immediate change after intervention in baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start23 Jun 2021
- Primary completion30 Oct 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahmyook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun-Joong Kim, Sahmyook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937270
- Sponsor's protocol ID
- 2-1040781-A-N-012021046HR
- Status last verified
- Feb 2022
- First submitted
- 9 Jun 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-frequency Deep Diathermy on Heart Rate Variability in Women With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT04937270
- Acronym / sponsor ID
- 2-1040781-A-N-012021046HR
- Conditions
- Primary Dysmenorrhea, Dysmucorrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Sahmyook UniversityUniversity, hospital or other
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 24 Jun 2021 (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.
Superficial heat therapy is mainly used to relieve menstrual pain, but it does not penetrate deeper than the skin tissue. In order to penetrate deep into the deep layers and promote tissue relaxation, deep heat therapy can be effective. The treatment time for deep heat treatment is controversial, and there is no study on deep heat treatment using radio frequency for dysmenorrhea. Therefore, in this study, by applying radiofrequency waves at different times to the lower abdomen for patients with primary dysmenorrhea, the pain and changes in the autonomic nervous system were compared with thermotherapy to suggest appropriate therapeutic interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High frequency application time is 5 minutes | Experimental | Device: High frequency therapy (5 minutes)The group which treats for 5 minutes by using the high-frequency therapy device |
| High frequency application time is 7 minutes | Experimental | Device: High frequency therapy (7 minutes)The group which treats for 7 minutes by using the high-frequency therapy device |
| High frequency application time is 9 minutes | Experimental | Device: High frequency therapy (9 minutes)The group which treats for 9 minutes by using the high-frequency therapy device |
| Superficial heat therapy | Active comparator | Device: Superficial heat therapyGroup treated with superficial heat therapy for 20 minutes |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women between the ages of 18-50
- Regular menstrual cycle (24-32 days)
- Those who have had symptoms of primary dysmenorrhea for at least 1 year
- Those who have lower back pain symptoms related to menstrual pain of 5 or higher on the Visual Analysis Scale (VAS)
- The body mass index is between 20-30
Key exclusion criteria (4 listed)
- pelvic inflammatory disease
- uterine fibroids, polycystic ovary syndrome. Those with gynecological findings such as endometriosis
- Those who have used an intrauterine contraceptive device
- Those who took birth control pills or nonsteroidal anti-inflammatory drugs at the time of the experiment
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 |
|---|---|---|
| High frequency therapy (5 minutes)The high-frequency therapy device (radio frequency therapy, WINBACK, Villeneuve Loubet France) used in this study was used to treat deep heat for 5 minutes using a 500 kHz resistive electric transfer (RET). | Device | High frequency application time is 5 minutes |
| High frequency therapy (7 minutes)The high-frequency therapy device (radio frequency therapy, WINBACK, Villeneuve Loubet France) used in this study was used to treat deep heat for 7 minutes using a 500 kHz resistive electric transfer (RET). | Device | High frequency application time is 7 minutes |
| High frequency therapy (9 minutes)The high-frequency therapy device (radio frequency therapy, WINBACK, Villeneuve Loubet France) used in this study was used to treat deep heat for 9 minutes using a 500 kHz resistive electric transfer (RET). | Device | High frequency application time is 9 minutes |
| Superficial heat therapyIn the physical therapy used in this study, it was applied for 20 minutes using conventionally used superficial heat therapy. | Device | Superficial heat therapy |
Primary outcome
Heart Rate Variability
Time frame: immediate change after intervention in baseline
Autonomic nervous system balance tester (SA3000new, Medicore Co. Korea) was used. The subjects placed electrodes on three areas (left arm, left leg, right leg) while lying down and performed for 3 minutes.
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 2 Mar 2022.
- Individual participant dataSharing planned: Yes
Related trials for Primary Dysmenorrhea
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High frequency therapy (5 minutes), High frequency therapy (7 minutes) and High frequency therapy (9 minutes) in people with Primary Dysmenorrhea and Dysmucorrhea, run by Sahmyook University 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 5 inclusion and 4 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 2 Mar 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. 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?
Heart Rate Variability (time frame: immediate change after intervention in baseline). 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 2 Mar 2022.