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Completed

NCT Number: NCT04937270

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

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.

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Key information

Conditions

Primary Dysmenorrhea Dysmucorrhea

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The wells neuropain clinic

Seoul, 05557, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 therapy

Device

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Sahmyook University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 24, 2021
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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