NCT06469632 Radiofrequency and Myofascial Pain Syndrome in Postpartum Pelvic Pain
| NCT ID | NCT06469632 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alcala |
| Condition | To be Approved by the Ethics Committee |
| Study Type | INTERVENTIONAL |
| Enrollment | 74 participants |
| Start Date | 2023-06-27 |
| Primary Completion | 2024-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 74 participants in total. It began in 2023-06-27 with a primary completion date of 2024-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
About 30% of women experience pain in the perineum and pelvic region one year after the vaginal labor, rising up to 50% when it is triggered during vaginal penetration, called this pain as dyspareunia. An early physiotherapy treatment could be the solution to the pain relief of these women. Thus, the objectives of the present randomised clinical trail are (i) to determine the effectiveness of a physiotherapy treatment based on education therapeutic, the treatment of myofascial pain syndrome (MPS) of the pelvic floor muscles (PFM), and PFM specific training with or without radiofrequency in reducing pain and improving sexual function; and, (ii) to know the facilitating factors and barriers in adherence and perceived self-efficacy towards physiotherapy treatment of women with pelviperineal pain in the postpartum. Methodology: randomized clinical trial with examinator blinding and two parallel groups, followed by a qualitative study. Thirty eight women per group will be needed with postpartum pelviperineal pain between 8 weeks after labour, with intensity ≥ 4 cm on the visual analogue scale. The assignment will be random to an Experimental 1 group based on therapeutic education, plus conservative and invasive treatment of MPS and specific PFM exercise versus an Experimental 2 group consisted in the same treatment plus non-ablative radiofrequency treatment. In both cases, 12 individual supervised sessions will be held by a physiotherapist specialized in women's health, with evaluations pre- and post-intervention, at 3 and 6 months. The outcome variables will be the intensity of the pain, the presence of MPS at PFM, the PFM contraction quality, sexual function and specific quality of life. The qualitative study will be carried out in the assessment 6 months post-intervention, through interviews semi-structured and focus groups. The interviews will be guided with previous questions established, recorded, transcribed and thematically analyzed by a panel of experts.
Eligibility Criteria
Inclusion Criteria: * Primiparous women * Eutocic vaginal birth * Postpartum pelviperineal pain 8 weeks after birth * Intensity ≥ 4 cm in the VAS * Freely signed the Informed consent Exclusion Criteria: * Multiparous women * Instrumental delivery * Cesarean delivery * Avulsion of the levator ani muscle * Diagnosis of coccygodynia and/or coccygeal pain * Sphincter anal injury during vaginal birth * History of pelvic fractures and/or neoplasms * Pregnant women * Neurological diseases * Vaginal infection or active urinary tract, or with any * Uterine device with metallic components * Women with cognitive, auditory and/or visual limitations to understand information, respond to questionnaires, consent and/or participate in the study.
Contact & Investigator
Beatriz Navarro-Brazález, PhD
PRINCIPAL INVESTIGATOR
Physiotherapy in Women's Health (FPSM) Research Group. Physiotherapy Department, Faculty of Medicine and Health Sciences, University of Alcalá, Alcalá de Henares, 28805 Madrid, Spain.
Frequently Asked Questions
Who can join the NCT06469632 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying To be Approved by the Ethics Committee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06469632 currently recruiting?
Yes, NCT06469632 is actively recruiting participants. Contact the research team at b.navarro@uah.es for enrollment information.
Where is the NCT06469632 trial being conducted?
This trial is being conducted at Alcalá de Henares, Spain.
Who is sponsoring the NCT06469632 clinical trial?
NCT06469632 is sponsored by University of Alcala. The principal investigator is Beatriz Navarro-Brazález, PhD at Physiotherapy in Women's Health (FPSM) Research Group. Physiotherapy Department, Faculty of Medicine and Health Sciences, University of Alcalá, Alcalá de Henares, 28805 Madrid, Spain.. The trial plans to enroll 74 participants.