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

Pelvic Floor Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04757077
• Other study ID #: PN/54/2021
• Status: Completed
• Start date: February 22, 2021
• Est. completion date: May 31, 2021

Study information

• Verified date: April 2021
• Source: Zelazna Medical Centre, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diastasis Recti and Weakness of the Linea Alba
• Diastasis, Muscle
• Pelvic Floor Disorders
• Pelvic Girdle Pain

Locations

Country	Name	City	State
Poland	St. Sophia's Specialist Hospital	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Zelazna Medical Centre, LLC

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perineometry of the pelvic floor - vaginal resting pressure.	Measurement of the vaginal resting pressure.	one time assessment, 6-24 weeks after delivery
Primary	Perineometry of the pelvic floor - vaginal squeeze pressure.	Measurement of the vaginal squeeze pressure.	one time assessment, 6-24 weeks after delivery
Primary	Palpable measurement of inter-recti distance (IRD)	Palpable measurement of inter-recti distance (IRD)	one time assessment, 6-24 weeks after delivery
Secondary	Perineometry of the pelvic floor - endurance	Pelvic floor endurance measurement (area under the curve).	one time assessment, 6-24 weeks after delivery
Secondary	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
Secondary	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
Secondary	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
Secondary	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