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

Not Applicable

Completed

• Conditions: Dysmucorrhea; Primary Dysmenorrhea
• Interventions: Device: High frequency therapy (7 minutes); Device: High frequency therapy (9 minutes); Device: High frequency therapy (5 minutes); Device: Superficial heat therapy

• Registration Number: NCT04937270
• Lead Sponsor: Sahmyook University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-17
• Study Start: 2021-06-23
• Study First Posted: 2021-06-24
• Primary Completion: 2021-10-30
• Study Completion: 2021-11-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-11
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 37

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High frequency application time is 7 minutes	High frequency therapy (7 minutes)	The group which treats for 7 minutes by using the high-frequency therapy device
High frequency application time is 9 minutes	High frequency therapy (9 minutes)	The group which treats for 9 minutes by using the high-frequency therapy device
High frequency application time is 5 minutes	High frequency therapy (5 minutes)	The group which treats for 5 minutes by using the high-frequency therapy device
Superficial heat therapy	Superficial heat therapy	Group treated with superficial heat therapy for 20 minutes

Primary Outcome Measures

Name	Time	Method
Heart Rate Variability	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.

Trial Locations

Locations (1)

The wells neuropain clinic; 🇰🇷 Seoul, Korea, Republic of