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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Floor Disorders; Pelvic Girdle Pain; Diastasis Recti and Weakness of the Linea Alba

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 01-004
    • St. Sophia's Specialist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women, 6-24 weeks after delivery

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
GROUP 1; Patients 6-24 weeks after delivery with postpartum PGP (Patients with symptoms and signs of PGP, PGP confirmed with dedicated functional tests).
GROUP 2; Patients 6-24 weeks after delivery, with no symptoms and signs of PGP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perineometry of the pelvic floor - vaginal resting pressure.	Measurement of the vaginal resting pressure.	one time assessment, 6-24 weeks after delivery
Perineometry of the pelvic floor - vaginal squeeze pressure.	Measurement of the vaginal squeeze pressure.	one time assessment, 6-24 weeks after delivery
Palpable measurement of inter-recti distance (IRD)	Palpable measurement of inter-recti distance (IRD)	one time assessment, 6-24 weeks after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perineometry of the pelvic floor - endurance	Pelvic floor endurance measurement (area under the curve).	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	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	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.	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.	one time assessment, 6-24 weeks after delivery

Collaborators and Investigators

• Sponsor: Żelazna Medical Centre, LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2021
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Pain; Pregnancy Complications; Joint Dislocations; Pelvic Pain; Pelvic Floor Disorders; Pelvic Girdle Pain; Diastasis, Muscle
• Other Study ID Numbers: PN/54/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No