Effect of Radiofrequency in the Treatment of de Novo Dyspareunia at 4 to 12 Months Postpartum: Randomised Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change of the baseline Level of pain during penetration and after 5 sessions
研究概览
简要总结
This study evaluates if the application of resistive capacitive monopolar radiofrequency therapy associated with Thiele massage is effective when treating de novo dyspareunia at 4 to 12 months postpartum.
详细描述
Dyspareunia is a type of genito-pelvic pain (GPP) that takes place during vaginal penetration at some point in sexual intercourse. It greatly affects quality of life as well as psychological and sexual wellbeing. A delivery with episiotomy, perineal tearing or labor dystocia using forceps or vacuum, are risk factors that contribute to the appearance of de novo dyspareunia with a prevalence of 17-45% at 6 months postpartum.
There is no evidence in the scientific literature of the effect of radiofrequency is this group of patients, however there is a clinical trial that describes the effect in scar tissue although not in the perineum. It is for all of the above that the following project is proposed, to evaluate the effect of RF in perineal healing and vaginal trigger points caused as a consequence of GPP.
The main objective of this study is to evaluate the role that radiofrequency (RF) plays in reducing the level of pain in de novo dyspareunia in postpartum women that persists from 4 to 12 months.
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 (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •4-12 postpartum
- •de novo dyspareunia after delivery
- •obstetric injury
- •Grant informed consent
排除标准
- •radiofrequency contraindications (pacemaker, active infection or pregnancy)
- •cesarean section
- •dyspareunia previous to labour
- •previous vulvo-vaginal pathology
- •patients with postpartum depression
- •patients with a pelvic region oncological history
- •patients with a history of pelvic trauma
研究组 & 干预措施
ON Radiofrequency treatment
Application of the technique in the intervention group (activated resistive capacitive monopolar radiofrequency therapy): the intervention group will receive treatment with activated RF, with the electrode at a medium intensity for 20 minutes per session during a total of 5 sessions, the 3 first ones held weekly and the 2 last ones every other week.
干预措施: Resistive Capicitive Monopolar Radiofrequency (Device)
Sham Radiofrequency treatment
Application of the technique in the intervention group (inactive resistive capacitive monopolar radiofrequency therapy): the intervention group will receive treatment with inactive RF, with the electrode at a medium intensity for 20 minutes per session during a total of 5 sessions, the 3 first ones held weekly and the 2 last ones every other week.
干预措施: Resistive Capicitive Monopolar Radiofrequency (Device)
结局指标
主要结局
Change of the baseline Level of pain during penetration and after 5 sessions
时间窗: Baseline and after 7 weeks
Using the Visual Analogue Scale (VAS), where 10 is the highest level of pain possible and 0 is no pain at all.
次要结局
- Change of the baseline muscle pain points and after 5 sessions(Baseline and after 7 weeks)
- Change in Pelvic floor dysfunctions in the baseline assesment and after 5 sessions(Baseline and after 7 weeks)
- Change of the baseline Sexual function and after 5 sessions(Baseline and after 7 weeks)
- Change of the baseline affection on the quality of life and after 5 sessions(Baseline and after 7 weeks)
研究者
Carla Box
Physical Therapist
Hospital Clinic of Barcelona