Pelvic Girdle PainNCT04757077
The Association Between Pelvic Floor Muscle Function, Diastasis Recti and Postpartum Pelvic Girdle Pain - a Matched Case Control Study.
An observational study of Pelvic Girdle Pain and Diastasis Recti and Weakness of the Linea Alba, run by Żelazna Medical Centre, LLC at 1 site in Poland.
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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Girdle Pain, Diastasis Recti and Weakness of the Linea Alba, Pelvic Floor Disorders
- How many people
- 56 participants
- Where
- 1 sitePoland
- Study dates
- 22 Feb 2021to 31 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women, 6-24 weeks after delivery
Who may be able to join
- 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
Who cannot join
- Diseases that can mimic PGP f.ex. Scheuermann disease, rheumatoid arthritis, Ehler's-Danlos Syndrome, hip dysplasia.
Trial locations and contacts
1 site in 1 country.
About this 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.
Read more
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
- Medical subject headings
- Pelvic Girdle Pain, Diastasis Recti And Weakness Of The Linea Alba, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Perineometry of the pelvic floor - vaginal resting pressure.
Measurement of the vaginal resting pressure.
Measured: one time assessment, 6-24 weeks after delivery
Perineometry of the pelvic floor - vaginal squeeze pressure.
Measurement of the vaginal squeeze pressure.
Measured: one time assessment, 6-24 weeks after delivery
Palpable measurement of inter-recti distance (IRD)
Palpable measurement of inter-recti distance (IRD)
Measured: one time assessment, 6-24 weeks after delivery
Secondary outcomes (5)
Perineometry of the pelvic floor - endurance
Pelvic floor endurance measurement (area under the curve).
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: one time assessment, 6-24 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start22 Feb 2021
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Girdle PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Żelazna Medical Centre, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757077
- Sponsor's protocol ID
- PN/54/2021
- Status last verified
- Apr 2021
- First submitted
- 15 Feb 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Pelvic Floor Muscle Function, Diastasis Recti and Postpartum Pelvic Girdle Pain - a Matched Case Control Study.
- ClinicalTrials.gov ID
- NCT04757077
- Acronym / sponsor ID
- PN/54/2021
- Conditions
- Pelvic Girdle Pain, Diastasis Recti and Weakness of the Linea Alba, Pelvic Floor Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Żelazna Medical Centre, LLCUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women, 6-24 weeks after delivery
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Diseases that can mimic PGP f.ex. Scheuermann disease, rheumatoid arthritis, Ehler's-Danlos Syndrome, hip dysplasia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perineometry of the pelvic floor - vaginal resting pressure.
Time frame: one time assessment, 6-24 weeks after delivery
Measurement of the vaginal resting pressure.
Perineometry of the pelvic floor - vaginal squeeze pressure.
Time frame: one time assessment, 6-24 weeks after delivery
Measurement of the vaginal squeeze pressure.
Palpable measurement of inter-recti distance (IRD)
Time frame: one time assessment, 6-24 weeks after delivery
Palpable measurement of inter-recti distance (IRD)
5 secondary outcomes
Perineometry of the pelvic floor - endurance
Time frame: one time assessment, 6-24 weeks after delivery
Diastasis Recti: palpation examination of the stability of the linea alba
Time frame: one time assessment, 6-24 weeks after delivery
Palpation examination of pelvic floor muscles with the use of PERFECT Scheme
Time frame: one time assessment, 6-24 weeks after delivery
Pain Catastrophizing Scale
Time frame: one time assessment, 6-24 weeks after delivery
Depression Anxiety Stress Scale 21
Time frame: one time assessment, 6-24 weeks after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Girdle Pain and Diastasis Recti and Weakness of the Linea Alba, run by Żelazna Medical Centre, LLC at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perineometry of the pelvic floor - vaginal resting pressure. (time frame: one time assessment, 6-24 weeks after delivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.