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Completed

NCT Number: NCT05403424

Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnancy 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.

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Key information

Conditions

Pregnant Women Musculoskeletal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Girdle Pain Pelvic Pain Signs and Symptoms

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-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)

Treatment and study plan

Evaluation of pain

Other

The severity of pelvic girdle pain will be evaluated with the Visual Analog Scale (VAS).

Application of pelvic girdle diagnostic tests

Diagnostic Test

Pelvic girdle pain diagnostic tests will be applied.

Evaluation of biomechanics and viscoelastic properties of thoracolumbar fascia

Other

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

Evaluation of activity limitation

Other

Pelvic Girdle Questionnaire will be filled

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Determining of painful areas

    Time frame: Baseline

    Marking of body chart

  2. 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).

  3. 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.

  4. Pelvic Girdle Questionnaire

    Time frame: Baseline

    Activity limitation will be evaluated Pelvic Girdle Questionnaire

  5. Evaluation of Body Weight

    Time frame: Measurement the change from baseline body weight (kg) at 12. and 22. weeks.

    Measuring of the Body Weight

  6. 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.

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 3, 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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