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NCT04937270 Clinical Trial

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

Primary Dysmenorrhea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04937270
Other study ID # 2-1040781-A-N-012021046HR
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 23, 2021
Est. completion date November 30, 2021

Study information
Verified date February 2022
Source Sahmyook University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date November 30, 2021
Est. primary completion date October 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of The wells neuropain clinic Seoul

Sponsors (1)
Lead Sponsor Collaborator
Sahmyook University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. immediate change after intervention in baseline
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