Actively Recruiting
Radiofrequency and Myofascial Pain Syndrome in Postpartum Pelvic Pain
Led by University of Alcala · Updated on 2024-06-21
74
Participants Needed
1
Research Sites
122 weeks
Total Duration
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AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Radiofrequency and Myofascial Pain Syndrome in Postpartum Pelvic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primiparous women
- Eutocic vaginal birth
- Pelviperineal pain starting 8 weeks after birth
- Pain intensity of 4 cm or higher on the visual analogue scale
- Signed informed consent freely given
You will not qualify if you...
- Multiparous women
- Instrumental delivery
- Cesarean delivery
- Avulsion of the levator ani muscle
- Diagnosis of coccygodynia or coccygeal pain
- Anal sphincter injury during vaginal birth
- History of pelvic fractures or tumors
- Currently pregnant
- Neurological diseases
- Vaginal infection or active urinary tract infection
- Use of uterine device with metallic components
- Cognitive, auditory, or visual limitations preventing understanding or participation
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Trial Site Locations
Total: 1 location
1
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, Spain, 28871
Actively Recruiting
Research Team
B
Beatriz Navarro-Brazález, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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