Clinical trial NCT04757077: The Association Between Pelvic Floor Muscle Function, Diastasis Recti and Postpartum Pelvic Girdle Pain - a Matched Case Control Study.
Official title: The Association Between Pelvic Floor Muscle Function, Diastasis Recti and Postpartum Pelvic Girdle Pain - a Matched Case Control Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Girdle Pain
Diastasis Recti and Weakness of the Linea Alba
Pelvic Floor Disorders
Lead sponsor: Żelazna Medical Centre, LLC
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women, 6-24 weeks after delivery

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 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.


Eligibility criteria: Inclusion Criteria:

* Vaginal labour (including vacuum extractor or forceps) or caesarean section
* For group with PGP: pain due to PGP
* For control group with no pain - no pain due to PGP
* Agreement to participate

Exclusion Criteria:

* Diseases that can mimic PGP f.ex. Scheuermann disease, rheumatoid arthritis, Ehler's-Danlos Syndrome, hip dysplasia.

Primary outcomes:
measure: Perineometry of the pelvic floor - vaginal resting pressure.
timeFrame: one time assessment, 6-24 weeks after delivery
measure: Perineometry of the pelvic floor - vaginal squeeze pressure.
timeFrame: one time assessment, 6-24 weeks after delivery
measure: Palpable measurement of inter-recti distance (IRD)
timeFrame: one time assessment, 6-24 weeks after delivery
Secondary outcomes:
measure: Perineometry of the pelvic floor - endurance
timeFrame: one time assessment, 6-24 weeks after delivery
measure: Diastasis Recti: palpation examination of the stability of the linea alba
timeFrame: one time assessment, 6-24 weeks after delivery
measure: Palpation examination of pelvic floor muscles with the use of PERFECT Scheme
timeFrame: one time assessment, 6-24 weeks after delivery
measure: Pain Catastrophizing Scale
timeFrame: one time assessment, 6-24 weeks after delivery
measure: Depression Anxiety Stress Scale 21
timeFrame: one time assessment, 6-24 weeks after delivery
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: St. Sophia's Specialist Hospital
Study officials:
References: