Radiofrequency and Myofascial Pain Syndrome in Postpartum Pelvic Pain
NCT Number: NCT06469632
Acronym: RASDOP
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: To be Approved by the Ethics Committee
Interventions: OTHER: Active Comparator: Experimental Group 1|OTHER: Experimental: Experimental Group 2
Sponsor: University of Alcala
Sex: FEMALE
Age: ADULT
Enrollment: 74
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-06-27
Completion Date: 2025-11
Locations: 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., Alcalá de Henares, Madrid, 28871, Spain

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.

Primary Outcome Measures: Pain intensity through the Verbal Numerical Scale (0 no pain, and 10 the most bearable pain), intensity, behavior and location (pain body chart)., Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment|Sexual function, Self-completion of the FSFI questionnaire, which evaluates sexual function based on 6 domains: desire, excitement, lubrication, orgasm, satisfaction and pain. The maximum score is 36, considering sexual dysfunction a value \>27., Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
Secondary Outcome Measures: Pelvic floor dysfunction symptoms, Presence of urinary, intestinal and/or symptoms suggestive of prolapse, Pre-treatment, post-treatment (after 12 sessions of physiotherapy treatment which will last approximately 3 months after starting the study), 3 and 6 months after treatment|PFM capacity of contraction through Modified Oxford Scale (0 no contraction, 5 strong contraction), Intravaginal palpation of pelvic floor muscles with one or two fingers., Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment|PFM capacity of relaxation (yes or no), Intravaginal palpation of pelvic floor muscles with one or two fingers., Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment|PFM basal tone in grams, Intravaginal dynamometry, Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment|PFM muscle strength in grams, Intravaginal dynamometry, Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment|Distance of the urogenital hiatus in milimeters, Assessment through transperineal ultrasound of the distance of the urogenital hiatus at rest, during a strong PFM contraction and during a pushing effort., Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment|Presence of MPS in PFM and abdominal muscles, Following the diagnostic criteria of Travel and Simons., Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment|Specific quality of life and impact of Pelvoc floor Disfunction using questionnaires: PFDI-20 and PFIQ-7, Through the questionnaires: Pelvic Floor Distress Inventory short version (PFDI-20) and Pelvic Floor Impact Questionnaire short form (PFIQ-7). In both questionnaires, the scores range between 0 and 300, where a higher score indicates more distress and more impact on quality of life., Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment|Self-efficacy, Through Broome Pelvic Muscle Self-Efficacy Scale. The score ranges from 0 to 100, where 100 implies greater self-efficacy., Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment