NCT06469632

Radiofrequency and Myofascial Pain Syndrome in Postpartum Pelvic Pain

Efficacy of Radiofrequency and the Treatment of Myofascial Pain Syndrome in Postpartum Pelvic Pain: Mixed Research Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: University of Alcala · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• To be Approved by the Ethics Committee

Interventions

Type	Name	Description
OTHER	Active Comparator: Experimental Group 1	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.
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. Non-ablative radiofrequency: using capacitive superficial electrodes and resistive superficial and intravaginal electrodes.

Timeline

• Start date: 2023-06-27
• Primary completion: 2024-10-01
• Completion: 2025-11-01
• First posted: 2024-06-21
• Last updated: 2024-06-21

Locations

1 site across 1 country: Spain