NCT04757077

The Association Between Pelvic Floor Muscle Function, Diastasis Recti and Postpartum Pelvic Girdle Pain - a Matched Case Control Study.

Completed Last updated 14 July 2021

What this trial tests

trial in Pelvic Girdle Pain in 56 participants. Completed in 31 May 2021.

Timeline

22 February 2021

Primary endpoint
31 May 2021

31 May 2021

Quick facts

Lead sponsor	Żelazna Medical Centre, LLC
Status	Completed
Study type	OBSERVATIONAL
Enrollment	56
Start date	22 February 2021
Primary completion	31 May 2021
Estimated completion	31 May 2021
Sites	1 location across Poland

Conditions studied

• Pelvic Girdle Pain — all drugs for Pelvic Girdle Pain →
• Diastasis Recti and Weakness of the Linea Alba — all drugs for Diastasis Recti and Weakness of the Linea Alba →
• Pelvic Floor Disorders — all drugs for Pelvic Floor Disorders →

Sponsor

Żelazna Medical Centre, LLC

Who can join

Adults 18 to 45, female only, with Pelvic Girdle Pain or Diastasis Recti and Weakness of the Linea Alba. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Association between Postpartum Pelvic Girdle Pain and Pelvic Floor Muscle Function, Diastasis Recti and Psychological Factors-A Matched Case-Control Study.
   Starzec-Proserpio M, Rejano-Campo M, Szymańska A, Szymański J, et al · · 2022 · cited 8× · PMID 35627771 · DOI 10.3390/ijerph19106236