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

Pregnant Women Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05403424
• Other study ID #: 33 09/03/2022
• Status: Not yet recruiting
• Start date: June 1, 2022
• Est. completion date: December 15, 2023

Study information

• Verified date: May 2022
• 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 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-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)

Related Conditions & MeSH terms

• Pelvic Girdle Pain
• Pregnant Women

Intervention

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
• Evaluation of activity limitation
Pelvic Girdle Questionnaire will be filled

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)

Alcaraz-Clariana S, García-Luque L, Garrido-Castro JL, Carmona-Pérez C, Rodrigues-de-Souza DP, Fernández-de-Las-Peñas C, Alburquerque-Sendín F. Influence of Spinal Movements Associated with Physical Evaluation on Muscle Mechanical Properties of the Lumbar — View Citation

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. — 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

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.2010 — 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 and at 22. 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 and at 22. 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 and at 22. 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 and at 22. 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 and at 22. week
Secondary	Determining of painful areas	Marking of body chart	Baseline
Secondary	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
Secondary	Application of PGP diagnostic tests	Pelvic Girdle Pain diagnostic tests will be applied.	Baseline
Secondary	Pelvic Girdle Questionnaire	Activity limitation will be evaluated Pelvic Girdle Questionnaire	Baseline
Secondary	Evaluation of Body Weight	Measuring of the Body Weight	Measurement the change from baseline body weight (kg) at 12. and 22. 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.and 22. weeks