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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnant Women; Pelvic Girdle Pain
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey
    • Istanbul Medeniyet University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Pregnant women with and without PGP and non-pregnant women

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1: Pregnant women with pelvic girdle pain; This group will consist of pregnant women diagnosed with pelvic girdle pain.	Other: Evaluation of pain; The severity of pelvic girdle pain will be evaluated with the Visual Analog Scale (VAS).; Diagnostic test: Application of pelvic girdle diagnostic tests; Pelvic girdle pain diagnostic tests will be applied.; 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 and measurements will be taken from three different points; Other: Evaluation of activity limitation; Pelvic Girdle Questionnaire will be filled
Group 2: Pregnant women without pelvic girdle pain; This group will consist of pregnant women who do not have pelvic girdle pain.	Other: Evaluation of pain; The severity of pelvic girdle pain will be evaluated with the Visual Analog Scale (VAS).; Diagnostic test: Application of pelvic girdle diagnostic tests; Pelvic girdle pain diagnostic tests will be applied.; 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 and measurements will be taken from three different points; Other: Evaluation of activity limitation; Pelvic Girdle Questionnaire will be filled
Group 3: Non-pregnant women; This group will consist of non-pregnant women.	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 and measurements will be taken from three different points

What is the study measuring?

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
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
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
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• Alcaraz-Clariana S, Garcia-Luque L, Garrido-Castro JL, Carmona-Perez C, Rodrigues-de-Souza DP, Fernandez-de-Las-Penas C, Alburquerque-Sendin F. Influence of Spinal Movements Associated with Physical Evaluation on Muscle Mechanical Properties of the Lumbar Paraspinal in Subjects with Acute Low Back Pain. Diagnostics (Basel). 2022 Jan 25;12(2):302. doi: 10.3390/diagnostics12020302.
• Aldabe D, Milosavljevic S, Bussey MD. A multivariate model for predicting PPGP considering postural adjustment parameters. Musculoskelet Sci Pract. 2020 Aug;48:102153. doi: 10.1016/j.msksp.2020.102153. Epub 2020 May 5.
• 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.
• Stuge B, Garratt A, Krogstad Jenssen H, Grotle M. The pelvic girdle questionnaire: a condition-specific instrument for assessing activity limitations and symptoms in people with pelvic girdle pain. Phys Ther. 2011 Jul;91(7):1096-108. doi: 10.2522/ptj.20100357. Epub 2011 May 19.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): June 15, 2023
• Study Completion (Anticipated): December 15, 2023

Study Registration Dates

• First Submitted: April 15, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: pregnant women; stiffness; pelvic girdle pain; creep; thoracolumbar fascia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Pain; Pelvic Pain; Pelvic Girdle Pain
• Other Study ID Numbers: 33 09/03/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No