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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05403424
Enrollment
103
Registered
2022-06-03
Start date
2022-06-01
Completion date
2025-08-15
Last updated
2026-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Girdle Pain, Pregnant Women

Keywords

pregnant women, pelvic girdle pain, thoracolumbar fascia, stiffness, creep

Brief summary

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.

Interventions

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

DIAGNOSTIC_TESTApplication of pelvic girdle diagnostic tests

Pelvic girdle pain diagnostic tests will be applied.

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

Pelvic Girdle Questionnaire will be filled

Sponsors

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of biomechanical properties of thoracolumbar fasciaMeasurement the change from baseline stiffness values of Thoracolumbar fascia at 12. week and at 22. weekMeasuring of the stiffness (N/m) of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.
Evaluation of viscoelastic properties of thoracolumbar fasciaMeasurement the change from baseline creep values of Thoracolumbar fascia at 12. week and at 22. weekMeasuring of the creep of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.

Secondary

MeasureTime frameDescription
Determining of painful areasBaselineMarking of body chart
Evaluation of painBaselinePain will be evaluated with Visual analog scale (VAS). The VAS is scaled between 0-10 points (0: no pain, 10: most severe pain).
Application of Pelvic Girdle Pain (PGP) diagnostic testsBaselineThe 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.
Pelvic Girdle QuestionnaireBaselineActivity limitation will be evaluated Pelvic Girdle Questionnaire
Evaluation of Body WeightMeasurement the change from baseline body weight (kg) at 12. and 22. weeks.Measuring of the Body Weight
Evaluation of Body Mass Index (BMI)Measurement the change from baseline BMI values at 12.and 22. weeksBMI (kg/m2) will be calculated as person's weight in kilograms divided by the square of height in meters.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 28, 2026