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Completed

NCT Number: NCT05335330

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 pilot 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.

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Key information

Conditions

Pregnant Women First Pregnancy

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

İstanbul Medeniyet University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First 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

Treatment and study plan

Evaluation of biomechanics and viscoelastic properties of thoracolumbar fascia

Other

The biomechanical and viscoelastic properties of the Thoracolumbar fascia will be measured in the side line position. Measurements will be taken from three different points; L1, L3-4 and L5 level.

Primary outcomes

  1. Evaluation of biomechanical properties of thoracolumbar fascia

    Time frame: Measurement the baseline stiffness values of Thoracolumbar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks

    Measuring of the stiffness (N/m) of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side line position.

  2. Evaluation of viscoelastic properties of thoracolumbar fascia

    Time frame: Measurement the baseline relaxation time values of Thoracolumbar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks

    Measuring of the relaxation time (ms) of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side line position.

  3. Evaluation of biomechanical properties of thoracolumbar fascia

    Time frame: Measurement the baseline tone values of Thoracolumbar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks

    Measuring of the tone (Hz) of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side line position.

  4. Evaluation of viscoelastic properties of thoracolumbar fascia

    Time frame: Measurement the baseline creep values of Thoracolumb Measurement the baseline creep values of Thoracolumbar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks

    Measuring of the creep of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side line position.

  5. Evaluation of biomechanical properties of thoracolumbar fascia

    Time frame: Measurement the baseline decrement values of Thoracolumbar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks

    Measuring of the decrement of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side line position.

Secondary outcomes

  1. Evaluation of Body Weight

    Time frame: Measurement the baseline body weight (kg) at evaluation time

    Measuring of the Body Weight

  2. Evaluation of Body Mass Index (BMI)

    Time frame: Measurement the baseline BMI values at evaluation time

    BMI (kg/m2) will be calculated as person's weight in kilograms divided by the square of height in meters.

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 19, 2022
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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