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.

Study Overview

• Status: Completed
• Conditions: Primary Dysmenorrhea; Dysmucorrhea
• Intervention / Treatment: Device: Superficial heat therapy; Device: High frequency therapy (5 minutes); Device: High frequency therapy (7 minutes); Device: High frequency therapy (9 minutes)

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05557
    • The wells neuropain clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Superficial heat therapy; Group treated with superficial heat therapy for 20 minutes	Device: Superficial heat therapy; In the physical therapy used in this study, it was applied for 20 minutes using conventionally used superficial heat therapy.
Experimental: High frequency application time is 5 minutes; The group which treats for 5 minutes by using the high-frequency therapy device	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).
Experimental: High frequency application time is 7 minutes; The group which treats for 7 minutes by using the high-frequency therapy device	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).
Experimental: High frequency application time is 9 minutes; The group which treats for 9 minutes by using the high-frequency therapy device	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sahmyook University

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: 2-1040781-A-N-012021046HR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No