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Effects of High-frequency Deep Diathermy on Heart Rate Variability in Women With Primary Dysmenorrhea

Effects of High-frequency Deep Diathermy on Heart Rate Variability in Women With Primary Dysmenorrhea

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04937270
Enrollment
37
Registered
2021-06-24
Start date
2021-06-23
Completion date
2021-11-30
Last updated
2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysmucorrhea, Primary Dysmenorrhea

Brief 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. 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.

Interventions

DEVICEHigh 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).

DEVICEHigh 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).

DEVICEHigh 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).

In the physical therapy used in this study, it was applied for 20 minutes using conventionally used superficial heat therapy.

Sponsors

Sahmyook University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Heart Rate Variabilityimmediate change after intervention in baselineAutonomic 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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026