Effect of Radiofrequency in the Treatment of de Novo Dyspareunia at 4 to 9 Months Postpartum.

Study Overview
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Brief Summary
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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 9 months postpartum.

Detailed Description
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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 9 months.

Official Title
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Effect of Radiofrequency in the Treatment of de Novo Dyspareunia at 4 to 9 Months Postpartum: Randomised Prospective Trial

Conditions
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Dyspareunia

Intervention / Treatment
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* Device: Resistive Capicitive Monopolar Radiofrequency


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 4-9 postpartum de novo dyspareunia after delivery obstetric injury Grant informed consent Exclusion Criteria: 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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ON Radiofrequency treatment<br>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. | Device: Resistive Capicitive Monopolar Radiofrequency<br>* 5 Radiofrequency sessions including the abdominal region, the vulva and pelvic floor tissue and Thiele massage done daily by the patient at home<br>|
| Sham Comparator: Sham Radiofrequency treatment<br>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. | Device: Resistive Capicitive Monopolar Radiofrequency<br>* 5 Radiofrequency sessions including the abdominal region, the vulva and pelvic floor tissue and Thiele massage done daily by the patient at home<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the baseline Level of pain during penetration and after 5 sessions | Using the Visual Analogue Scale (VAS), where 10 is the highest level of pain possible and 0 is no pain at all. | Baseline and after 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the baseline Sexual function and after 5 sessions | Using the Female Sexual Function Index (FSFI), where higher scores indicate higher degrees of sexual functioning of a total of 36 points (and lower pain). | Baseline and after 7 weeks | 
| Change of the baseline muscle pain points and after 5 sessions | A physical evaluation held by the physical therapist seeking for pain points and asking the patient to score the amount of pain using the visual analogue scale (VAS) where 10 is the highest level of pain possible and 0 is no pain at all. | Baseline and after 7 weeks | 
| Change in Pelvic floor dysfunctions in the baseline assesment and after 5 sessions | Using the Pelvic Floor Distress Inventory-20 questionnaire (PFDI-20), in which the higher the score the greater the perceived impact that the pelvic floor dysfunction has on the patient's life (range 0 to 300 points). | Baseline and after 7 weeks | 
| Change of the baseline affection on the quality of life and after 5 sessions | Using the EuroQuality of life-5D (EQ5D),where the maximum score of 1 indicates the best health state and therefore, higher scores indicate more severe or frequent problems (range from 0 to 10) | Baseline and after 7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dyspareunia, radiofrequency, postpartum pain, perineal massage, episiotomy