Effect of Radiofrequency in the Treatment of de Novo Dyspareunia at 4 to 16 Months Postpartum.
NCT ID: NCT05417334
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2021-03-18
2026-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Resistive Capicitive Monopolar Radiofrequency
5 Radiofrequency sessions including the abdominal region, the vulva and pelvic floor tissue and Thiele massage done daily by the patient at home
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.
Resistive Capicitive Monopolar Radiofrequency
5 Radiofrequency sessions including the abdominal region, the vulva and pelvic floor tissue and Thiele massage done daily by the patient at home
Interventions
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Resistive Capicitive Monopolar Radiofrequency
5 Radiofrequency sessions including the abdominal region, the vulva and pelvic floor tissue and Thiele massage done daily by the patient at home
Eligibility Criteria
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Inclusion Criteria
* de novo dyspareunia after delivery
* obstetric injury
* Grant informed consent
Exclusion Criteria
* cesarean section
* dyspareunia previous to labour
* previous vulvo-vaginal pathology
* patients with postpartum depression
* patients with a pelvic region oncological history
FEMALE
No
Sponsors
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Hospital Clinic of Barcelona
OTHER
Responsible Party
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Carla Box
Physical Therapist
Locations
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Hospital Clinic Barcelona
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HCB/2020/0484
Identifier Type: -
Identifier Source: org_study_id
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