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Clinical Trials/NCT05335330
NCT05335330
Recruiting
Not Applicable

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

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey1 site in 1 country163 target enrollmentJune 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnant Women
Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Enrollment
163
Locations
1
Primary Endpoint
Evaluation of biomechanical properties of thoracolumbar fascia
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
November 15, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Evaluation of Body Weight(Measurement the baseline body weight (kg) at evaluation time)
  • Evaluation of Body Mass Index (BMI)(Measurement the baseline BMI values at evaluation time)

Study Sites (1)

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