Physiotherapy Treatment With Capacitive Resistive Monopolar Radiofrecuency in Young Women With Dyspareunia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Pain in sexual intercourse
研究概览
简要总结
The hypothesis of this study is that capacitive-resistive monopolar radiofrecuency (CRMRF) with vaginal manual physiotherapy improves sexual health in young women suffering from dyspareunia (pain during sexual intercourse). The realization of studies that help to know the therapeutic possibilities in the field of dyspareunia seems necessary, taking into account the number of women affected, as well as the deficits of scientific evidence in this field.
The main objective of this study is to analyze whether the use of CRMRF brings additional benefits to the results of manual therapy on dyspareunia in young women.
Likewise, it intends to analyze the data for two secondary objectives:
- Analyze changes in different areas of women's sexual function in young people with dyspareunia through treatment (Desire, arousal, lubrication, orgasm, satisfaction and pain).
- Study if the use of CRMRF is an added benefit in personal perception while receiving treatment.
详细描述
After being informed of the study objectives, inclusion and exclusion criteria, and study methodology, all patients have signed informed consents. The participation of women in this study is entirely voluntary and if, during the course of the study, a participant decides to withdraw, she can do it freely at the time she considers appropriate, without the need to give explanations.
At week 0, patients who meet the eligibility requirements will be randomized using "Random.org" in a single-blind manner (participant) in two Arms:
- Treatment Group (CRMRF and physical therapy modalities on pelvic floor)
- Sham Group (only physical therapy modalities on pelvic floor).
There will be 4 identical treatment sessions (one each week). These sessions are protocolized. Data collection will be carried out before the first session, after the last session and 12 weeks after the end of the treatment. The approximate duration of each session is 40 minutes. Sessions with data collection will be approximately between 45 minutes to 1 hour.
During the first visit, patients will be asked to answer a series of questions and respond to some questionnaires (FSFI, Female Sexual Function Index and FSM, Women's Sexual Function). The results of the different tests carried out, as well as all the documentation referring to the participants, are totally confidential and will only be available to the main researcher, the collaborators and the health authorities competent, if applicable.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between 18 and 30 years old.
- •Women who have pain during sexual intercourse, classified as dyspareunia superficial in the last 12 months.
排除标准
- •Use of antidepressants.
- •Pregnancy and lactation.
- •Cardiac pathologies.
- •Epilepsy.
- •Acute inflammatory process.
- •Pacemaker.
- •Skin or mucous infections in the urogenital area.
- •Any alteration that prevents the understanding of the informed consent.
结局指标
主要结局
Pain in sexual intercourse
时间窗: Five months
The pain was described using the anamnesis, the pain score of the "FSFI" scale (Female Sexual Function Index) and the scale of pain "VAS" (Visual Analogue Scale) that is a numerical rating scale that goes from zero to ten. Zero represents the absence of pain and ten the greatest pain that the patient can imagine. The pain was described also using vaginal dilators and seeing at which measure the pain begins.
次要结局
- State of the musculature of the pelvic floor(Five months)
- Female sexual function(Five months)
- Quality of sexual relations(Five months)
- Problems with vaginal penetration(Five months)
- Perception of treatment(Five months)