Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04757077
Status:
COMPLETED
Last Update Posted:
2021-07-14
First Post:
2021-02-15
Brief Title:
The Association Between Pelvic Floor Muscle Function Diastasis Recti and Postpartum Pelvic Girdle Pain - a Matched Case Control Study
Sponsor:
Żelazna Medical Centre LLC
Organization:
Żelazna Medical Centre LLC
Study Overview
Official Title:
The Association Between Pelvic Floor Muscle Function Diastasis Recti and Postpartum Pelvic Girdle Pain - a Matched Case Control Study
Status:
COMPLETED
Status Verified Date:
2021-04
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:
None
Brief Summary:
Background Pregnancy-related pelvic girdle pain PGP can appear during pregnancy directly after labour or can be delayed to 3 weeks postpartum Pain is experienced between the posterior iliac crest and the gluteal fold particularly in the vicinity of the sacroiliac joint SIJ The pain may radiate in the posterior thigh and can also occur in conjunction withor separately in the symphysis The endurance capacity for standing walking and sitting is diminished The diagnosis of PGP can be reached after exclusion of lumbar causes The pain or functional disturbances in relation to PGP must be reproducible by specific clinical tests Lack of accurate and early diagnosis of the PGP postpartum may contribute to development of chronic condition lowering quality of life years after delivery There is uncertainty regarding the association between the function of the pelvic floor muscles PFM diastasis recti and postpartum pelvic girdle pain PGP Although widely researched abroad there is a paucity in research about biopsychosocial profile of women with postpartum PGP in Poland
Objectives The aim of this one-to-one matched case-control study it to examine whether there is any difference in PFM function and diastasis recti between women with and without clinically diagnosed PGP Additionally differences in biopsychosocial profile depression anxiety stress catastrophizing and kinesiophobia will be assessed
Materials and methods Because of low incidence of researched condition a case control study will be the study design of choice Women 6-24 weeks after delivery with postpartum PGP will be matched with those with no PGP Subjects assessment will consist of palpation examination of diastasis recti inter-recti distance and pelvic floor muscles Perineometry of the pelvic floor will also be conducted Additionally several questionnaires for the assessment of mental processing will be used Depression Anxiety Stress Scale 21 Pain Catastrophizing Scale and Tampa Scale of Kinesiophobia Participants will be matched according to age parity and time postpartum
Expected results To our knowledge postpartum pelvic girdle pain has not been extensively studied in Poland so far The study will bring information about the possible associations with postpartum PGP We hypothesize that the study will confirm our clinical observations about pelvic floor dysfunction and maladaptive mental processing in women with postpartum PGP
Objectives The aim of this one-to-one matched case-control study it to examine whether there is any difference in PFM function and diastasis recti between women with and without clinically diagnosed PGP Additionally differences in biopsychosocial profile depression anxiety stress catastrophizing and kinesiophobia will be assessed
Materials and methods Because of low incidence of researched condition a case control study will be the study design of choice Women 6-24 weeks after delivery with postpartum PGP will be matched with those with no PGP Subjects assessment will consist of palpation examination of diastasis recti inter-recti distance and pelvic floor muscles Perineometry of the pelvic floor will also be conducted Additionally several questionnaires for the assessment of mental processing will be used Depression Anxiety Stress Scale 21 Pain Catastrophizing Scale and Tampa Scale of Kinesiophobia Participants will be matched according to age parity and time postpartum
Expected results To our knowledge postpartum pelvic girdle pain has not been extensively studied in Poland so far The study will bring information about the possible associations with postpartum PGP We hypothesize that the study will confirm our clinical observations about pelvic floor dysfunction and maladaptive mental processing in women with postpartum PGP
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