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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
110
5 Radiofrequency sessions including the abdominal region, the vulva and pelvic floor tissue and Thiele massage done daily by the patient at home
Hospital Clinic Barcelona
Barcelona, Spain
RECRUITINGChange 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.
Time frame: Baseline and after 7 weeks
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).
Time frame: 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.
Time frame: 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).
Time frame: 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)
Time frame: Baseline and after 7 weeks
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