St. Sophia's Specialist Hospital
Warsaw, 01-004, Poland
NCT Number: NCT04757077
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 with/or 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.
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Notify Me18 year–45 year
Female
Observational
Warsaw, 01-004, Poland
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: one time assessment, 6-24 weeks after delivery
Measurement of the vaginal resting pressure.
Time frame: one time assessment, 6-24 weeks after delivery
Measurement of the vaginal squeeze pressure.
Time frame: one time assessment, 6-24 weeks after delivery
Palpable measurement of inter-recti distance (IRD)
Time frame: one time assessment, 6-24 weeks after delivery
Pelvic floor endurance measurement (area under the curve).
Time frame: one time assessment, 6-24 weeks after delivery
Assesment of the stability of the linea alba during abdominal crunch - bulging means that it is unstable
Time frame: one time assessment, 6-24 weeks after delivery
Assesment of pelvic floor muscles with the use of PERFECT Scheme
Time frame: one time assessment, 6-24 weeks after delivery
Assesment of Catastrophizing. It consists of 13 items rated on 5- point scale (0-not at all, 4-all the time). The score range is 0-52. Higher scores indicates higher amounts of pain catastrophizing.
Time frame: one time assessment, 6-24 weeks after delivery
Assesment of Catastrophizing. It is a self-report scale which consists of 21 items and 4-point severity scales (0- did not apply to me at all, 3-applied to me very much, or most of the time). Total scale thus range between 0 and 120, and those for each of the subscales may range between 0 and 42. Moderate outcomes indicates elevated depression, anxiety, or stress.
Żelazna Medical Centre, LLC
Other
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