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

NCT04757077 | Completed

• 1 other identifier: PN/54/2021
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Girdle Pain; Diastasis Recti and Weakness of the Linea Alba; Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Perineometry of the pelvic floor - endurance

  one time assessment, 6-24 weeks after delivery

• Diastasis Recti: palpation examination of the stability of the linea alba

  one time assessment, 6-24 weeks after delivery

• Palpation examination of pelvic floor muscles with the use of PERFECT Scheme

  one time assessment, 6-24 weeks after delivery

• Pain Catastrophizing Scale

  one time assessment, 6-24 weeks after delivery

• Depression Anxiety Stress Scale 21

  one time assessment, 6-24 weeks after delivery

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women, 6-24 weeks after delivery

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Żelazna Medical Centre, LLC: lead

Study Sites (1)

St. Sophia's Specialist Hospital

Warsaw, 01-004, Poland

Location

MeSH Terms

Conditions

Pelvic Girdle Pain; Diastasis Recti And Weakness Of The Linea Alba; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 16, 2021
• Study Start: February 22, 2021
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: July 14, 2021

Record last verified: 2021-04

Locations

PL (1)