Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnant Women

• Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05335330
• Collaborator: (none)
• Enrollment: 163
• Location: 1
• Anticipated Duration (Months): 17.5
• Patients Per Site Per Month: 9.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnant Women	Other: Evaluation of biomechanics and viscoelastic properties of Thoracolumbar fascia

Study Design

• Study Type: Observational
• Anticipated Enrollment: 163 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Investigation of Trimester-Specific Normative Values of Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnant Women
• Anticipated Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Jun 15, 2023
• Anticipated Study Completion Date: Nov 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Group: Pregnant women (first pregnancy) This group will consist of women in the first trimester of pregnancy. Pregnant women will be evaluated 3 times in total, each measurement being in a different trimester.	Other: Evaluation of biomechanics and viscoelastic properties of Thoracolumbar fascia; The biomechanical and viscoelastic properties of the Thoracolumbar fascia will be measured in the prone position. Measurements will be taken from three different points.

Outcome Measures

Primary Outcome Measures

1. Evaluation of biomechanical properties of thoracolumbar fascia [Measurement the change from baseline stiffness values of Thoracolumbar fascia at 12. week, at 22. week and at 34. 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 [Measurement the change from baseline decrement values of Thoracolumbar fascia at 12. week, at 22. week and at 34. 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 [Measurement the change from baseline tone values of Thoracolumbar fascia at 12. week, at 22. week and at 34. 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 [Measurement the change from baseline relaxation time values of Thoracolumbar fascia at 12. week, at 22. week and at 34. week]

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

5. Evaluation of viscoelastic properties of thoracolumbar fascia [Measurement the change from baseline creep values of Thoracolumbar fascia at 12. week, at 22. week and at 34. week]

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

Secondary Outcome Measures

1. Evaluation of Body Weight [Measurement the change from baseline body weight (kg) at 12., 22. and 34. weeks.]]

   Measuring of the Body Weight

2. Evaluation of Body Mass Index (BMI) [Measurement the change from baseline BMI values at 12., 22. and 34. weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	İstanbul Medeniyet University	İstanbul		Turkey

Sponsors and Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• ClinicalTrials.gov Identifier: NCT05335330
• Other Study ID Numbers: 34
• First Posted: Apr 19, 2022
• Last Update Posted: Apr 19, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: pregnant women; thoracolumbar fascia; stiffness; creep

Study Results

No Results Posted as of Apr 19, 2022