An interventional study of Active Comparator: Experimental Group 1 and Experimental: Experimental Group 2 in To be Approved by the Ethics Committee, sponsored by University of Alcala. Recruiting at 1 site in Spain. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-06-21.
Sponsored by University of Alcala · Not applicable, Interventional, and Treatment
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.
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Exclusion Criteria:
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.
Other: Active Comparator: Experimental Group 1
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.
Other: Experimental: Experimental Group 2
Multimodal physiotherapy treatment composed of: Therapeutic education about anatomy, physiology and pathophysiology of the abdomino-pelvic cavity, pelvic floor dysfunctions and risk factors, the concept of pain and its associated factors, as well as individual strategies to manage pain. Specific PFM exercises performing different types of contractions aimed at improving proprioception, strength, resistance and relaxation capacity. Conservative and invasive treatment of MPS active myofascial trigger points (MTP) will be treated by dry needling and Swiss technique. Latent MTP will be treated using the Swiss technique.
Multimodal physiotherapy treatment composed of: Therapeutic education about anatomy, physiology and pathophysiology of the abdomino-pelvic cavity, pelvic floor dysfunctions and risk factors, the concept of pain and its associated factors, as well as individual strategies to manage pain. Specific PFM exercises performing different types of contractions aimed at improving proprioception, strength, resistance and relaxation capacity. Conservative and invasive treatment of MPS active myofascial trigger points (MTP) will be treated by dry needling and Swiss technique. Latent MTP will be treated using the Swiss technique. Non-ablative radiofrequency: using capacitive superficial electrodes and resistive superficial and intravaginal electrodes.
Pain intensity through the Verbal Numerical Scale (0 no pain, and 10 the most bearable pain)
intensity, behavior and location (pain body chart).
Time frame: 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.
Time frame: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
Pelvic floor dysfunction symptoms
Presence of urinary, intestinal and/or symptoms suggestive of prolapse
Time frame: 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.
Time frame: 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.
Time frame: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
PFM basal tone in grams
Intravaginal dynamometry
Time frame: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
PFM muscle strength in grams
Intravaginal dynamometry
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-treatment, post-treatment (6 weeks after starting the study), 3 and 6 months after treatment
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