An observational study in Pelvic Girdle Pain, Diastasis Recti and Weakness of the Linea Alba and Pelvic Floor Disorders, sponsored by Żelazna Medical Centre, LLC. Completed at 1 site in Poland. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-14.
Sponsored by Żelazna Medical Centre, LLC · Observational
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.
41 studies on the registry are indexed under Diastasis, Muscle; 9 are open to participants now.
This study's enrollment of 56 is close to the median of 53 across 10 observational studies indexed under Diastasis, Muscle.
Browse Diastasis, Muscle studies →Żelazna Medical Centre, LLC is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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Women, 6-24 weeks after delivery
Exclusion Criteria:
Patients 6-24 weeks after delivery with postpartum PGP (Patients with symptoms and signs of PGP, PGP confirmed with dedicated functional tests).
Patients 6-24 weeks after delivery, with no symptoms and signs of PGP.
Perineometry of the pelvic floor - vaginal resting pressure.
Measurement of the vaginal resting pressure.
Time frame: one time assessment, 6-24 weeks after delivery
Perineometry of the pelvic floor - vaginal squeeze pressure.
Measurement of the vaginal squeeze pressure.
Time frame: one time assessment, 6-24 weeks after delivery
Palpable measurement of inter-recti distance (IRD)
Palpable measurement of inter-recti distance (IRD)
Time frame: one time assessment, 6-24 weeks after delivery
Perineometry of the pelvic floor - endurance
Pelvic floor endurance measurement (area under the curve).
Time frame: one time assessment, 6-24 weeks after delivery
Diastasis Recti: palpation examination of the stability of the linea alba
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
Palpation examination of pelvic floor muscles with the use of PERFECT Scheme
Assesment of pelvic floor muscles with the use of PERFECT Scheme
Time frame: one time assessment, 6-24 weeks after delivery
Pain Catastrophizing Scale
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
Depression Anxiety Stress Scale 21
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.
Time frame: one time assessment, 6-24 weeks after delivery
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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