Effects of High-frequency Deep Diathermy on Heart Rate Variability in Women With Primary Dysmenorrhea
1 other identifier
interventional
37
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2021
CompletedStudy Start
First participant enrolled
June 23, 2021
CompletedFirst Posted
Study publicly available on registry
June 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2021
CompletedMarch 2, 2022
February 1, 2022
4 months
June 9, 2021
February 11, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
High frequency application time is 5 minutes
EXPERIMENTALThe group which treats for 5 minutes by using the high-frequency therapy device
High frequency application time is 7 minutes
EXPERIMENTALThe group which treats for 7 minutes by using the high-frequency therapy device
High frequency application time is 9 minutes
EXPERIMENTALThe group which treats for 9 minutes by using the high-frequency therapy device
Superficial heat therapy
ACTIVE COMPARATORGroup treated with superficial heat therapy for 20 minutes
Interventions
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).
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).
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).
In the physical therapy used in this study, it was applied for 20 minutes using conventionally used superficial heat therapy.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The wells neuropain clinic
Seoul, 05557, South Korea
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher
Study Record Dates
First Submitted
June 9, 2021
First Posted
June 24, 2021
Study Start
June 23, 2021
Primary Completion
October 30, 2021
Study Completion
November 30, 2021
Last Updated
March 2, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will share