Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnant Women-Pilot Study

NCT05335330 | Completed

• 1 other identifier: 34 09/03/2022
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 1

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 pilot 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.

Conditions

Pregnant Women; First Pregnancy

Keywords

pregnant women; thoracolumbar fascia; stiffness; creep

Outcome Measures

Primary Outcomes (5)

• 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 side line position.

  Measurement the baseline stiffness values of Thoracolumbar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks

• Evaluation of viscoelastic properties of thoracolumbar fascia

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

  Measurement the baseline relaxation time values of Thoracolumbar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks

• Evaluation of biomechanical properties of thoracolumbar fascia

  Measuring of the tone (Hz) of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side line position.

  Measurement the baseline tone values of Thoracolumbar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks

• Evaluation of viscoelastic properties of thoracolumbar fascia

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

  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

• Evaluation of biomechanical properties of thoracolumbar fascia

  Measuring of the decrement of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side line position.

  Measurement the baseline decrement values of Thoracolumbar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks

Secondary Outcomes (2)

• 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 Arms (3)

First trimester pregnant women (first pregnancy)

Pregnant women who are in their first pregnancy and in their first trimester will be evaluated.

Other: Evaluation of biomechanics and viscoelastic properties of Thoracolumbar fascia

Second trimester pregnant women (first pregnancy)

Pregnant women who are in their first pregnancy and in their second trimester will be evaluated.

Other: Evaluation of biomechanics and viscoelastic properties of Thoracolumbar fascia

Third trimester pregnant women (first pregnancy)

Pregnant women who are in their first pregnancy and in their third trimester will be evaluated.

Other: Evaluation of biomechanics and viscoelastic properties of Thoracolumbar fascia

Interventions

Evaluation of biomechanics and viscoelastic properties of Thoracolumbar fascia OTHER

The biomechanical and viscoelastic properties of the Thoracolumbar fascia will be measured in the side line position. Measurements will be taken from three different points; L1, L3-4 and L5 level.

First trimester pregnant women (first pregnancy); Second trimester pregnant women (first pregnancy); Third trimester pregnant women (first pregnancy)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Pregnant women at the first pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women (first pregnancy)

You may qualify if:

• First pregnancy
• They are between the ages of 18-40
• Pre-pregnancy Body-Mass-Index (BMI) \< 30 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

İstanbul Medeniyet University

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• 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. doi: 10.1007/s00421-018-3867-2. Epub 2018 Apr 20.

  PMID: 29679246 BACKGROUND

• 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.

  PMID: 30254233 BACKGROUND

• 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.

  PMID: 12551802 BACKGROUND

• 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: 10.3389/fphys.2021.718068. eCollection 2021.

  PMID: 34616306 BACKGROUND

• 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.

  PMID: 28167175 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 19, 2022
• Study Start: June 1, 2022
• Primary Completion: January 9, 2024
• Study Completion: January 9, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

TU (1)