Radiofrequency and Myofascial Pain Syndrome in Postpartum Pelvic Pain (RASDOP)

University of Alcala

Status: Enrolling

Conditions: To be Approved by the Ethics Committee

Treatments: Other: Active Comparator: Experimental Group 1; Other: Experimental: Experimental Group 2

Study type: Interventional

Funder types: Other

Identifiers

NCT06469632

2023/00201/001

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

Experimental Group 1

Active Comparator group

Description:

There will be 12 individual sessions guided by a physiotherapist specialized in Women's Health. The approximate duration will be 45 minutes/session, 2 times a week for 6 weeks. The intervention will consist of a multimodal physiotherapy treatment based on therapeutic patient education, specific PFM exercises, and conservative and invasive treatment of the MPS. Pre- and post-intervention assessments will be carried out, and at 3 and 6 months after the intervention, by an examining physiotherapist who will be blinding for the intervention group.

Treatment:

Other: Active Comparator: Experimental Group 1

Experimental Group 2

Experimental group

Description:

There will be 12 individual sessions guided by a physiotherapist specialized in Women's Health. The approximate duration will be 45 minutes/session, 2 times a week for 6 weeks. The intervention will consist of a multimodal physiotherapy treatment based on therapeutic patient education, specific PFM exercises, conservative and invasive treatment of the MPS and non-ablative radiofrequency. Pre- and post-intervention assessments will be carried out, and at 3 and 6 months after the intervention, by an examining physiotherapist who will be blinding for the intervention group.

Treatment:

Other: Experimental: Experimental Group 2