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临床试验/NCT04937270
NCT04937270已完成不适用

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

Sahmyook University1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2021年6月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
1
主要终点
Heart Rate Variability

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

High frequency application time is 5 minutes

Experimental

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

干预措施: High frequency therapy (5 minutes) (Device)

High frequency application time is 7 minutes

Experimental

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

干预措施: High frequency therapy (7 minutes) (Device)

High frequency application time is 9 minutes

Experimental

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

干预措施: High frequency therapy (9 minutes) (Device)

Superficial heat therapy

Active Comparator

Group treated with superficial heat therapy for 20 minutes

干预措施: Superficial heat therapy (Device)

结局指标

主要结局

Heart Rate Variability

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hyun-Joong Kim

Researcher

Sahmyook University

研究点 (1)

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