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

NCT05403424 | Recruiting

• 1 other identifier: 33 09/03/2022
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnant Women; Pelvic Girdle Pain

Keywords

pregnant women; pelvic girdle pain; 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 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 Outcomes (6)

• Determining of painful areas

  Baseline

• Evaluation of pain

  Baseline

• Application of Pelvic Girdle Pain (PGP) diagnostic tests

  Baseline

• Pelvic Girdle Questionnaire

  Baseline

• Evaluation of Body Weight

  Measurement the change from baseline body weight (kg) at 12. and 22. weeks.

Study Arms (3)

Group 1: Pregnant women with pelvic girdle pain

This group will consist of pregnant women diagnosed with pelvic girdle pain.

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

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; Diagnostic Test: Application of pelvic girdle diagnostic tests; Other: Evaluation of biomechanics and viscoelastic properties of thoracolumbar fascia; Other: Evaluation of activity limitation

Group 3: Non-pregnant women

This group will consist of non-pregnant women.

Other: Evaluation of biomechanics and viscoelastic properties of thoracolumbar fascia

Interventions

Evaluation of pain OTHER

The severity of pelvic girdle pain will be evaluated with the Visual Analog Scale (VAS).

Group 1: Pregnant women with pelvic girdle pain; Group 2: Pregnant women without pelvic girdle pain

Application of pelvic girdle diagnostic tests DIAGNOSTIC_TEST

Pelvic girdle pain diagnostic tests will be applied.

Group 1: Pregnant women with pelvic girdle pain; Group 2: Pregnant women without pelvic girdle pain

Evaluation of biomechanics and viscoelastic properties of thoracolumbar fascia OTHER

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

Group 1: Pregnant women with pelvic girdle pain; Group 2: Pregnant women without pelvic girdle pain; Group 3: Non-pregnant women

Evaluation of activity limitation OTHER

Pelvic Girdle Questionnaire will be filled

Group 1: Pregnant women with pelvic girdle pain; Group 2: Pregnant women without pelvic girdle pain

Eligibility Criteria

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

Study Population

Pregnant women with and without PGP and non-pregnant women

You may qualify if:

• 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

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 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)

Sponsors & Collaborators

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

Study Sites (1)

İstanbul Medeniyet University

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• 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.

  PMID: 35204392 RESULT

• 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.

  PMID: 32560861 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 21596959 RESULT

MeSH Terms

Conditions

Pelvic Girdle Pain

Condition Hierarchy (Ancestors)

Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain

Central Study Contacts

Nilüfer KABLAN, PhD

CONTACT

05067638556; niluferkablan@yahoo.com

Merve Can, Msc

CONTACT

05388397713; mervecaann@gmail.com

Study Design

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

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: June 3, 2022
• Study Start: June 1, 2022
• Primary Completion: August 15, 2025
• Study Completion: October 15, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

TU (1)