Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnant Women

Pregnant Women Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05335330
• Other study ID #: 34 09/03/2022
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: November 15, 2023

Study information

• Verified date: April 2023
• Source: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Contact: Nilüfer KABLAN, PhD
• Phone: 05067638556
• Email: niluferkablan[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 163
• Est. completion date: November 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnant Women

Intervention

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.

Locations

Country	Name	City	State
Turkey	Istanbul Medeniyet University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Hu X, Lei D, Li L, Leng Y, Yu Q, Wei X, Lo WLA. Quantifying paraspinal muscle tone and stiffness in young adults with chronic low back pain: a reliability study. Sci Rep. 2018 Sep 25;8(1):14343. doi: 10.1038/s41598-018-32418-x. — View Citation

Lohr C, Braumann KM, Reer R, Schroeder J, Schmidt T. Reliability of tensiomyography and myotonometry in detecting mechanical and contractile characteristics of the lumbar erector spinae in healthy volunteers. Eur J Appl Physiol. 2018 Jul;118(7):1349-1359. — View Citation

Sanjana F, Chaudhry H, Findley T. Effect of MELT method on thoracolumbar connective tissue: The full study. J Bodyw Mov Ther. 2017 Jan;21(1):179-185. doi: 10.1016/j.jbmt.2016.05.010. Epub 2016 Jun 3. — View Citation

Tincello DG, Teare J, Fraser WD. Second trimester concentration of relaxin and pregnancy related incontinence. Eur J Obstet Gynecol Reprod Biol. 2003 Feb 10;106(2):237-8. doi: 10.1016/s0301-2115(02)00360-3. No abstract available. — View Citation

Wu Z, Wang Y, Ye Z, Guan Y, Ye X, Chen Z, Li C, Chen G, Zhu Y, Du J, Chen G, Liu W, Xu X. Effects of Age and Sex on Properties of Lumbar Erector Spinae in Healthy People: Preliminary Results From a Pilot Study. Front Physiol. 2021 Sep 20;12:718068. doi: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, at 22. week and at 34. week
Primary	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, at 22. week and at 34. week
Primary	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, at 22. week and at 34. week
Primary	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, at 22. week and at 34. week
Primary	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, at 22. week and at 34. week
Secondary	Evaluation of Body Weight	Measuring of the Body Weight	Measurement the change from baseline body weight (kg) at 12., 22. and 34. weeks.]
Secondary	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., 22. and 34. weeks