Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnancy Pelvic Girdle Pain

July 24, 2026 updated by: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Investigation of Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnant Women With Pelvic Girdle Pain

It has not been objectively clarified how the thoracolumbar fascia (TLF) changes the biomechanical adaptations that occur in the lumbopelvic region during pregnancy and whether it is associated with pelvic girdle pain (PGP). Therefore, the aim of this study is to determine the biomechanical and viscoelastic properties of TLF, which adapts to the changes in the lumbopelvic region in pregnant women with pelvic girdle pain, and to investigate its relationship with PGP.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
103

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Pregnant women with and without PGP and non-pregnant women

Description

Inclusion Criteria:

  • First-time pregnancy
  • Pregnant women diagnosed with pelvic girdle pain in 1st and 2nd trimesters
  • Pregnant women who do not have pelvic girdle pain in 1st and 2nd trimesters
  • Women not being pregnant
  • Pre-pregnancy Body-Mass-Index (BMI) < 30 kg/m2

Exclusion Criteria:

  • Presence of connective tissue disease
  • Deterioration of skin integrity in measurement areas
  • Presence of orthopedic, neurological, rheumatic problems that may cause musculoskeletal disorders and deviations from normal biomechanical alignment
  • History of spine, pelvis, or lower extremity surgery or fracture in the past 6 months
  • Definition of chronic low back-pelvic region pain (lasting for more than 3 months and pain severity >4 according to VAS) before pregnancy
  • Identification of metabolic disorders such as Type I, II diabetes, gestational diabetes mellitus (GDM), preeclampsia before and/or during pregnancy)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group 1: Pregnant women with pelvic girdle pain
This group will consist of pregnant women diagnosed with pelvic girdle pain.
Other: Evaluation of pain
The severity of pelvic girdle pain will be evaluated with the Visual Analog Scale (VAS).
Diagnostic test: Application of pelvic girdle diagnostic tests
Pelvic girdle pain diagnostic tests will be applied.
Other: Evaluation of biomechanics and viscoelastic properties of thoracolumbar fascia
The biomechanical and viscoelastic properties of the thoracolumbar fascia will be measured in the prone position and measurements will be taken from three different points
Other: Evaluation of activity limitation
Pelvic Girdle Questionnaire will be filled
Group 2: Pregnant women without pelvic girdle pain
This group will consist of pregnant women who do not have pelvic girdle pain.
Other: Evaluation of pain
The severity of pelvic girdle pain will be evaluated with the Visual Analog Scale (VAS).
Diagnostic test: Application of pelvic girdle diagnostic tests
Pelvic girdle pain diagnostic tests will be applied.
Other: Evaluation of biomechanics and viscoelastic properties of thoracolumbar fascia
The biomechanical and viscoelastic properties of the thoracolumbar fascia will be measured in the prone position and measurements will be taken from three different points
Other: Evaluation of activity limitation
Pelvic Girdle Questionnaire will be filled
Group 3: Non-pregnant women
This group will consist of non-pregnant women.
Other: Evaluation of biomechanics and viscoelastic properties of thoracolumbar fascia
The biomechanical and viscoelastic properties of the thoracolumbar fascia will be measured in the prone position and measurements will be taken from three different points

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of biomechanical properties of thoracolumbar fascia
Time Frame: Measurement the change from baseline stiffness values of Thoracolumbar fascia at 12. week and at 22. week
Measuring of the stiffness (N/m) of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.
Measurement the change from baseline stiffness values of Thoracolumbar fascia at 12. week and at 22. week
Evaluation of biomechanical properties of thoracolumbar fascia
Time Frame: Measurement the change from baseline decrement values of Thoracolumbar fascia at 12. week and at 22. week
Measuring of the decrement of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.
Measurement the change from baseline decrement values of Thoracolumbar fascia at 12. week and at 22. week
Evaluation of biomechanical properties of thoracolumbar fascia
Time Frame: Measurement the change from baseline tone values of Thoracolumbar fascia at 12. week and at 22. week
Measuring of the tone (Hz) of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.
Measurement the change from baseline tone values of Thoracolumbar fascia at 12. week and at 22. week
Evaluation of viscoelastic properties of thoracolumbar fascia
Time Frame: Measurement the change from baseline creep values of Thoracolumbar fascia at 12. week and at 22. week
Measuring of the creep of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.
Measurement the change from baseline creep values of Thoracolumbar fascia at 12. week and at 22. week
Evaluation of viscoelastic properties of thoracolumbar fascia
Time Frame: Measurement the change from baseline relaxation time values of Thoracolumbar fascia at 12. week and at 22. week
Measuring of thethe relaxation time (ms) of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.
Measurement the change from baseline relaxation time values of Thoracolumbar fascia at 12. week and at 22. week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pelvic Girdle Questionnaire
Time Frame: Baseline
Activity limitation will be evaluated Pelvic Girdle Questionnaire
Baseline
Determining of painful areas
Time Frame: Baseline
Marking of body chart
Baseline
Evaluation of pain
Time Frame: Baseline
Pain will be evaluated with Visual analog scale (VAS). The VAS is scaled between 0-10 points (0: no pain, 10: most severe pain).
Baseline
Evaluation of Body Weight
Time Frame: Measurement the change from baseline body weight (kg) at 12. and 22. weeks.
Measuring of the Body Weight
Measurement the change from baseline body weight (kg) at 12. and 22. weeks.
Evaluation of Body Mass Index (BMI)
Time Frame: Measurement the change from baseline BMI values at 12.and 22. weeks
BMI (kg/m2) will be calculated as person's weight in kilograms divided by the square of height in meters.
Measurement the change from baseline BMI values at 12.and 22. weeks
Application of Pelvic Girdle Pain (PGP) diagnostic tests
Time Frame: Baseline
The PGP diagnostic tests will be applied. The posterior pelvic pain provocation test is a pain provocation test used to determine the presence of sacroiliac dysfunction. No score is defined for tests.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 33 09/03/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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