Clinical trial NCT05403424: Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnancy Pelvic Girdle Pain
Official title: Investigation of Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnant Women With Pelvic Girdle Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnant Women
Pelvic Girdle Pain
Keywords: pregnant women
pelvic girdle pain
thoracolumbar fascia
stiffness
creep
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 60
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 with and without PGP and non-pregnant women

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Evaluation of biomechanical properties of thoracolumbar fascia
timeFrame: Measurement the change from baseline stiffness values of Thoracolumbar fascia at 12. week and at 22. week
measure: Evaluation of biomechanical properties of thoracolumbar fascia
timeFrame: Measurement the change from baseline decrement values of Thoracolumbar fascia at 12. week and at 22. week
measure: Evaluation of biomechanical properties of thoracolumbar fascia
timeFrame: Measurement the change from baseline tone values of Thoracolumbar fascia at 12. week and at 22. week
measure: Evaluation of viscoelastic properties of thoracolumbar fascia
timeFrame: Measurement the change from baseline creep values of Thoracolumbar fascia at 12. week and at 22. week
measure: Evaluation of viscoelastic properties of thoracolumbar fascia
timeFrame: Measurement the change from baseline relaxation time values of Thoracolumbar fascia at 12. week and at 22. week
Secondary outcomes:
measure: Determining of painful areas
timeFrame: Baseline
measure: Evaluation of pain
timeFrame: Baseline
measure: Application of Pelvic Girdle Pain (PGP) diagnostic tests
timeFrame: Baseline
measure: Pelvic Girdle Questionnaire
timeFrame: Baseline
measure: Evaluation of Body Weight
timeFrame: Measurement the change from baseline body weight (kg) at 12. and 22. weeks.
measure: Evaluation of Body Mass Index (BMI)
timeFrame: Measurement the change from baseline BMI values at 12.and 22. weeks
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: İstanbul Medeniyet University
Study officials:
References:
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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.20100357. Epub 2011 May 19.