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

Primary Purpose

Primary Dysmenorrhea, Dysmucorrhea

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
High frequency therapy (5 minutes)
High frequency therapy (7 minutes)
High frequency therapy (9 minutes)
Superficial heat therapy
Sponsored by
Sahmyook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • The wells neuropain clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

High frequency application time is 5 minutes

High frequency application time is 7 minutes

High frequency application time is 9 minutes

Superficial heat therapy

Arm Description

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

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

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

Group treated with superficial heat therapy for 20 minutes

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 9, 2021
Last Updated
February 11, 2022
Sponsor
Sahmyook University
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1. Study Identification

Unique Protocol Identification Number
NCT04937270
Brief Title
Effects of High-frequency Deep Diathermy on Heart Rate Variability in Women With Primary Dysmenorrhea
Official Title
Effects of High-frequency Deep Diathermy on Heart Rate Variability in Women With Primary Dysmenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 23, 2021 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahmyook University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea, Dysmucorrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High frequency application time is 5 minutes
Arm Type
Experimental
Arm Description
The group which treats for 5 minutes by using the high-frequency therapy device
Arm Title
High frequency application time is 7 minutes
Arm Type
Experimental
Arm Description
The group which treats for 7 minutes by using the high-frequency therapy device
Arm Title
High frequency application time is 9 minutes
Arm Type
Experimental
Arm Description
The group which treats for 9 minutes by using the high-frequency therapy device
Arm Title
Superficial heat therapy
Arm Type
Active Comparator
Arm Description
Group treated with superficial heat therapy for 20 minutes
Intervention Type
Device
Intervention Name(s)
High frequency therapy (5 minutes)
Intervention Description
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
Intervention Name(s)
High frequency therapy (7 minutes)
Intervention Description
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
Intervention Name(s)
High frequency therapy (9 minutes)
Intervention Description
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
Intervention Name(s)
Superficial heat therapy
Intervention Description
In the physical therapy used in this study, it was applied for 20 minutes using conventionally used superficial heat therapy.
Primary Outcome Measure Information:
Title
Heart Rate Variability
Description
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.
Time Frame
immediate change after intervention in baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
The wells neuropain clinic
City
Seoul
ZIP/Postal Code
05557
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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