Efficacy of Radiofrequency in Primary Dysmenorrhea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Dysmenorrheal pain intensity
研究概览
简要总结
The main objective of the study is to evaluate the effect of radiofrequency on pain associated with primary dysmenorrhea.
The data collected will be: Intensity of pain with the Numeric Pain Rating Scale (NPRS), pressure pain at three points of referred pain from the gynecological system, need or not to take medication, general quality of life with the SF-12 (short form 12) and quality of life in relation to menstruation with the CVM-22. They will be collected at the start of treatment, after the first post-intervention menstruation and after the second post-intervention menstruation.
This study is a randomized clinical trial with two intervention groups and a control group, whose study population is women with primary dysmenorrhea.
The sample size has been calculated with the G* Power 1.9.7 software using repeated measures ANOVA, assuming a two-sided significance level (α=0.05) and 90% power (β=0.10) and 10% losses. A sample of 45 participants (n) was determined to detect a significant change of 1.5 points in the variable measured with the NRS. Forty-five participants were included in this study. In the two intervention groups, radiofrequency will be applied (20 minute sessions for 3 weeks with a frequency of 3 times/week), transabdominal in one group and intravaginal in the other.
Participants must be women between 18 and 35 years old, with regular menstrual cycles (22-38 days according to FIGO), be nulliparous and also not present any of the exclusion criteria detailed in the study.
The data obtained will be analyzed and compared between the different groups in order to draw conclusions.
详细描述
Dysmenorrhea is a gynecological clinical entity that can be defined as menstrual pain. It usually begins a couple of days before the bleeding or coinciding with the start of the bleeding and usually lasts between 8 and 72 hours.
The main symptom is pelvic and / or abdominal pain that can spread to the lower back or lower limbs. On a psychological level, it associates pictures of depression, anxiety or irritability. It also affects in a very negative way the quality of life, work and / or academic performance (causing episodes of absenteeism) and the social sphere of the women who suffer from it.
In recent years, alternative treatments to pharmacological treatments have been gaining strength, among which physiotherapy stands out. Techniques such as manual therapy, transcutaneous electrical nerve stimulation (TENS), thermotherapy, kinesiology tape, stretching, therapeutic exercises ... are applied in women with primary dysmenorrhea and have been evaluated in numerous studies, most of which are of poor methodological quality.
In clinical practice, one of the physiotherapy modalities that has been applied the most in urogynecological pathologies in women is radiofrequency. Radiofrequency is a physiotherapy intervention that consists of the transfer of energy to the tissues in a resistive or capacitive way using wave frequencies between 0.5 and 1.5 megahertz (MHz). However, at present, there are no clinical trials randomized and controlled that evaluates the effectiveness of radiofrequency in any urogynecological pathology, including primary dysmenorrhea.
Objective: The aim of this study is to assess the effect of radiofrequency on pain associated with primary dysmenorrhea.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 18-35 years.
- •Menstrual pain: During bleeding and/or the previous 48 hours.
- •Nulliparous.
- •Regular menstrual cycles (24-38 days according to FIGO).
排除标准
- •Currently using contraceptives that prevent intracavitary application (hormonal intrauterine devices and vaginal rings).
- •Have any recent abdominal or pelvic surgery that prevents the application of intra/extracavitary heat.
- •Dysmenorrhea secondary to other gynecological pathologies (endometriosis, adenomyosis, uterine fibroids...)
- •Pregnancy.
- •Have received physiotherapy treatment for the painful episode in the six months prior to the study.
- •To present situations of contraindication of diathermy, radiofrequency or tecartherapy: implanted devices that work with batteries (pacemakers), metallic implants near the lumbopelvic region, uncontrolled or recent cancer processes, recent hemorrhages, alterations in sensitivity in the area to be treated , local active infections near the region to be treated, febrile states, skin wounds and epileptic processes.
研究组 & 干预措施
Transabdominal radiofrequency application
Tecartherapy equipment (Capenergy CM500) specially designed for Uro-Gynecological Physiotherapy will be used.
A transabdominal radiofrequency application will be performed, with a suprapubic active plate and a passive plate at the sacral level.
Patient position: Supine position. Sessions:9 Duration: 20 minutes Total intervention: 3 weeks Frequency: 3 times a week sessions will be held three times a week for three weeks
干预措施: Transabdominal radiofrecuency application (Device)
Intracavitary radiofrequency application
Tecartherapy equipment (Capenergy CM500) specially designed for Uro-Gynecological Physiotherapy will be used.
An intracavitary vaginal radiofrequency application will be performed, with an active intracavitary head and with a fixed plate at the sacral level.
Patient position: Supine position. Sessions:9 Duration: 20 minutes Total intervention: 3 weeks Frequency: 3 times a week sessions will be held three times a week for three weeks
干预措施: Intracavitary radiofrequency application (Device)
Control Group
Not treatment received
结局指标
主要结局
Dysmenorrheal pain intensity
时间窗: Two month
Dysmenorrheal pain intensity (measured using the NPRS scale) at rest. It will be evaluated three times with 1 minute between the three evaluations and the average will be noted.
Dysmenorrheal pain intensity
时间窗: Baseline
Dysmenorrheal pain intensity (measured using the NPRS scale) at rest. It will be evaluated three times with 1 minute between the three evaluations and the average will be noted.
Dysmenorrheal pain intensity
时间窗: One month
Dysmenorrheal pain intensity (measured using the NPRS scale) at rest. It will be evaluated three times with 1 minute between the three evaluations and the average will be noted.
次要结局
- Quality of life during menstruation.(Two month)
- Quality of life (General)(Two month)
- Pressure Pain Threshold(Two month)
- Number and quantity of drugs.(Two month)
- Quality of life during menstruation.(Baseline)
- Quality of life during menstruation.(One month)
- Quality of life (General)(Baseline)
- Quality of life (General)(One month)
- Pressure Pain Threshold(Baseline)
- Pressure Pain Threshold(One month)
- Number and quantity of drugs.(Baseline)
- Number and quantity of drugs.(One month)