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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pregnant Women, Pelvic Girdle Pain

Intervention / Treatment
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* Other: Evaluation of pain
* Diagnostic Test: Application of pelvic girdle diagnostic tests
* Other: Evaluation of biomechanics and viscoelastic properties of thoracolumbar fascia
* Other: Evaluation of activity limitation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1: Pregnant women with pelvic girdle pain<br>This group will consist of pregnant women diagnosed with pelvic girdle pain. | Other: Evaluation of pain<br>* The severity of pelvic girdle pain will be evaluated with the Visual Analog Scale (VAS).<br>Diagnostic Test: Application of pelvic girdle diagnostic tests<br>* Pelvic girdle pain diagnostic tests will be applied.<br>Other: Evaluation of biomechanics and viscoelastic properties of thoracolumbar fascia<br>* 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<br>Other: Evaluation of activity limitation<br>* Pelvic Girdle Questionnaire will be filled<br>|
| Group 2: Pregnant women without pelvic girdle pain<br>This group will consist of pregnant women who do not have pelvic girdle pain. | Other: Evaluation of pain<br>* The severity of pelvic girdle pain will be evaluated with the Visual Analog Scale (VAS).<br>Diagnostic Test: Application of pelvic girdle diagnostic tests<br>* Pelvic girdle pain diagnostic tests will be applied.<br>Other: Evaluation of biomechanics and viscoelastic properties of thoracolumbar fascia<br>* 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<br>Other: Evaluation of activity limitation<br>* Pelvic Girdle Questionnaire will be filled<br>|
| Group 3: Non-pregnant women<br>This group will consist of non-pregnant women. | Other: Evaluation of biomechanics and viscoelastic properties of thoracolumbar fascia<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of biomechanical properties of thoracolumbar fascia | 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 and at 22. week | 
| Evaluation of biomechanical properties of thoracolumbar fascia | 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 and at 22. week | 
| Evaluation of biomechanical properties of thoracolumbar fascia | 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 and at 22. week | 
| Evaluation of viscoelastic properties of thoracolumbar fascia | 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 and at 22. week | 
| Evaluation of viscoelastic properties of thoracolumbar fascia | 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 and at 22. week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determining of painful areas | Marking of body chart | Baseline | 
| Evaluation of pain | Pain will be evaluated with Visual analog scale (VAS). The VAS is scaled between 0-10 points (0: no pain, 10: most severe pain). | Baseline | 
| Application of PGP diagnostic tests | Pelvic Girdle Pain diagnostic tests will be applied. | Baseline | 
| Pelvic Girdle Questionnaire | Activity limitation will be evaluated Pelvic Girdle Questionnaire | Baseline | 
| Evaluation of Body Weight | Measuring of the Body Weight | Measurement the change from baseline body weight (kg) at 12. and 22. weeks. | 
| Evaluation of Body Mass Index (BMI) | 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.and 22. weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnant women, pelvic girdle pain, thoracolumbar fascia, stiffness, creep