Clinical trial NCT06469632: Radiofrequency and Myofascial Pain Syndrome in Postpartum Pelvic Pain
Official title: Efficacy of Radiofrequency and the Treatment of Myofascial Pain Syndrome in Postpartum Pelvic Pain: Mixed Research Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: To be Approved by the Ethics Committee
Keywords: Pelvic Pain
Physiotherapy
Therapeutic adherence
Postpartum
Pelvic floor
Radiofrequency
Myofascial Pain Syndrome
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Pain intensity through the Verbal Numerical Scale (0 no pain, and 10 the most bearable pain)
timeFrame: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
measure: Sexual function
timeFrame: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
Secondary outcomes:
measure: Pelvic floor dysfunction symptoms
timeFrame: 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
measure: PFM capacity of contraction through Modified Oxford Scale (0 no contraction, 5 strong contraction)
timeFrame: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
measure: PFM capacity of relaxation (yes or no)
timeFrame: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
measure: PFM basal tone in grams
timeFrame: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
measure: PFM muscle strength in grams
timeFrame: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
measure: Distance of the urogenital hiatus in milimeters
timeFrame: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
measure: Presence of MPS in PFM and abdominal muscles
timeFrame: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
measure: Specific quality of life and impact of Pelvoc floor Disfunction using questionnaires: PFDI-20 and PFIQ-7
timeFrame: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
measure: Self-efficacy
timeFrame: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
Other outcomes:
Locations:
city: Alcalá de Henares
country: Spain
facility: 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.
state: Madrid
Study officials:
affiliation: 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.
name: Beatriz Navarro-Brazález, PhD
role: PRINCIPAL_INVESTIGATOR
References: