Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnant Women

April 11, 2023 updated by: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Investigation of Trimester-Specific Normative Values of Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnant Women

Pregnancy causes the development of biomechanical adaptations in the musculoskeletal system, especially in the lumbopelvic region. In this context, the thoracolumbar fascia (TLF) is the most important structure in this region and is an exoskeleton for the muscles of the lumbar region. However, it has not been objectively clarified how the TLF adapts to the changes in the lumbopelvic region during pregnancy. Therefore, the aim of this study is to investigate the trimester-specific biomechanical (stiffness, decrement and tone) and viscoelastic (creep and relaxation time) properties of the TLF, which adapts to the lumbopelvic region changes in pregnant women.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

163

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

  • Turkey
      • İstanbul, Turkey
        • Recruiting
        • Istanbul Medeniyet University

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

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Pregnant women (first pregnancy)

Description

Inclusion Criteria:

  • First pregnancy
  • Being in the first trimester of pregnancy
  • They are between the ages of 18-40
  • 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 in biomechanical alignment
  • History of spine, pelvis or lower extremity surgery or fracture in the past 6 months
  • Description of chronic (more than 3 months) lumbar-pelvic region pain before pregnancy
  • Defining metabolic disorders such as type I, II diabetes, gestational diabetes mellitus (GDM), preeclampsia
  • Having Pelvic Girdle Pain

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
Intervention / Treatment
Group: Pregnant women (first pregnancy)
This group will consist of women in the first trimester of pregnancy. Pregnant women will be evaluated 3 times in total, each measurement being in a different trimester.
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. Measurements will be taken from three different points.

What is the study measuring?

Primary Outcome Measures

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, at 22. week and at 34. 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, at 22. week and at 34. week
Evaluation of biomechanical properties of thoracolumbar fascia
Time Frame: Measurement the change from baseline decrement values of Thoracolumbar fascia at 12. week, at 22. week and at 34. 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, at 22. week and at 34. week
Evaluation of biomechanical properties of thoracolumbar fascia
Time Frame: Measurement the change from baseline tone values of Thoracolumbar fascia at 12. week, at 22. week and at 34. 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, at 22. week and at 34. week
Evaluation of viscoelastic properties of thoracolumbar fascia
Time Frame: Measurement the change from baseline relaxation time values of Thoracolumbar fascia at 12. week, at 22. week and at 34. 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, at 22. week and at 34. week
Evaluation of viscoelastic properties of thoracolumbar fascia
Time Frame: Measurement the change from baseline creep values of Thoracolumbar fascia at 12. week, at 22. week and at 34. 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, at 22. week and at 34. week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Body Weight
Time Frame: Measurement the change from baseline body weight (kg) at 12., 22. and 34. weeks.]
Measuring of the Body Weight
Measurement the change from baseline body weight (kg) at 12., 22. and 34. weeks.]
Evaluation of Body Mass Index (BMI)
Time Frame: Measurement the change from baseline BMI values at 12., 22. and 34. 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., 22. and 34. weeks

Collaborators and Investigators

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

Sponsor

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Anticipated)

June 15, 2023

Study Completion (Anticipated)

November 15, 2023

Study Registration Dates

First Submitted

April 12, 2022

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 19, 2022

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 34 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.

Clinical Trials on Pregnant Women

Clinical Trials on Evaluation of biomechanics and viscoelastic properties of Thoracolumbar fascia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe