Clinical trial NCT05335330: Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnant Women-Pilot Study
Official title: Investigation of Trimester-Specific Normative Values of Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnant Women-Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnant Women
First Pregnancy
Keywords: pregnant women
thoracolumbar fascia
stiffness
creep
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 145
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women (first pregnancy)

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.


Eligibility criteria: Inclusion Criteria:

* First pregnancy
* They are between the ages of 18-40
* Pre-pregnancy Body-Mass-Index (BMI) \&lt; 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

Primary outcomes:
measure: Evaluation of biomechanical properties of thoracolumbar fascia
timeFrame: Measurement the baseline stiffness values of Thoracolumbar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
measure: Evaluation of viscoelastic properties of thoracolumbar fascia
timeFrame: Measurement the baseline relaxation time values of Thoracolumbar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
measure: Evaluation of biomechanical properties of thoracolumbar fascia
timeFrame: Measurement the baseline tone values of Thoracolumbar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
measure: Evaluation of viscoelastic properties of thoracolumbar fascia
timeFrame: 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
measure: Evaluation of biomechanical properties of thoracolumbar fascia
timeFrame: Measurement the baseline decrement values of Thoracolumbar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Secondary outcomes:
measure: Evaluation of Body Weight
timeFrame: Measurement the baseline body weight (kg) at evaluation time
measure: Evaluation of Body Mass Index (BMI)
timeFrame: Measurement the baseline BMI values at evaluation time
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: İstanbul Medeniyet University
Study officials:
References:
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. doi: 10.1007/s00421-018-3867-2. Epub 2018 Apr 20.
citation: 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.
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.
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: 10.3389/fphys.2021.718068. eCollection 2021.
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.