Ignite Creation Date:
2024-07-17 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469632
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2023-12-07
Brief Title:
Radiofrequency and Myofascial Pain Syndrome in Postpartum Pelvic Pain
Sponsor:
University of Alcala
Organization:
University of Alcala
Study Overview
Official Title:
Efficacy of Radiofrequency and the Treatment of Myofascial Pain Syndrome in Postpartum Pelvic Pain Mixed Research Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RASDOP
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 womens 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
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 womens 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None