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

NCT ID: NCT04937270

Last Updated: 2022-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-23

Study Completion Date

2021-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Dysmenorrhea Dysmucorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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High frequency application time is 5 minutes

The group which treats for 5 minutes by using the high-frequency therapy device

Group Type EXPERIMENTAL

High frequency therapy (5 minutes)

Intervention Type 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 application time is 7 minutes

The group which treats for 7 minutes by using the high-frequency therapy device

Group Type EXPERIMENTAL

High frequency therapy (7 minutes)

Intervention Type 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 application time is 9 minutes

The group which treats for 9 minutes by using the high-frequency therapy device

Group Type EXPERIMENTAL

High frequency therapy (9 minutes)

Intervention Type 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

Group treated with superficial heat therapy for 20 minutes

Group Type ACTIVE_COMPARATOR

Superficial heat therapy

Intervention Type DEVICE

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

Interventions

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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).

Intervention Type DEVICE

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).

Intervention Type DEVICE

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).

Intervention Type DEVICE

Superficial heat therapy

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sahmyook University

OTHER

Sponsor Role lead

Responsible Party

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Hyun-Joong Kim

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The wells neuropain clinic

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2-1040781-A-N-012021046HR

Identifier Type: -

Identifier Source: org_study_id

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