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

• Conditions: Pelvic Girdle Pain; Pregnant Women
• Interventions: 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

• Registration Number: NCT05403424
• Lead Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-15
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-31
• Last Update Submitted: 2022-05-31
• Study Start: 2022-06-01
• Study First Posted: 2022-06-03
• Last Update Posted: 2022-06-03
• Primary Completion: 2023-06-15
• Study Completion: 2023-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2: Pregnant women without pelvic girdle pain	Evaluation of activity limitation	This group will consist of pregnant women who do not have pelvic girdle pain.
Group 2: Pregnant women without pelvic girdle pain	Evaluation of pain	This group will consist of pregnant women who do not have pelvic girdle pain.
Group 1: Pregnant women with pelvic girdle pain	Application of pelvic girdle diagnostic tests	This group will consist of pregnant women diagnosed with pelvic girdle pain.
Group 2: Pregnant women without pelvic girdle pain	Application of pelvic girdle diagnostic tests	This group will consist of pregnant women who do not have pelvic girdle pain.
Group 2: Pregnant women without pelvic girdle pain	Evaluation of biomechanics and viscoelastic properties of thoracolumbar fascia	This group will consist of pregnant women who do not have pelvic girdle pain.
Group 3: Non-pregnant women	Evaluation of biomechanics and viscoelastic properties of thoracolumbar fascia	This group will consist of non-pregnant women.
Group 1: Pregnant women with pelvic girdle pain	Evaluation of pain	This group will consist of pregnant women diagnosed with pelvic girdle pain.
Group 1: Pregnant women with pelvic girdle pain	Evaluation of activity limitation	This group will consist of pregnant women diagnosed with pelvic girdle pain.
Group 1: Pregnant women with pelvic girdle pain	Evaluation of biomechanics and viscoelastic properties of thoracolumbar fascia	This group will consist of pregnant women diagnosed with pelvic girdle pain.

Primary Outcome Measures

Name	Time	Method
Evaluation of biomechanical properties of thoracolumbar fascia	Measurement the change from baseline tone values of Thoracolumbar fascia at 12. week and at 22. week	Measuring of the tone (Hz) of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.
Evaluation of viscoelastic properties of thoracolumbar fascia	Measurement the change from baseline relaxation time values of Thoracolumbar fascia at 12. week and at 22. week	Measuring of thethe relaxation time (ms) of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.

Secondary Outcome Measures

Name	Time	Method
Determining of painful areas	Baseline	Marking of body chart
Evaluation of pain	Baseline	Pain will be evaluated with Visual analog scale (VAS). The VAS is scaled between 0-10 points (0: no pain, 10: most severe pain).
Application of Pelvic Girdle Pain (PGP) diagnostic tests	Baseline	The PGP diagnostic tests will be applied. The posterior pelvic pain provocation test is a pain provocation test used to determine the presence of sacroiliac dysfunction. No score is defined for tests.
Pelvic Girdle Questionnaire	Baseline	Activity limitation will be evaluated Pelvic Girdle Questionnaire
Evaluation of Body Weight	Measurement the change from baseline body weight (kg) at 12. and 22. weeks.	Measuring of the Body Weight
Evaluation of Body Mass Index (BMI)	Measurement the change from baseline BMI values at 12.and 22. weeks	BMI (kg/m2) will be calculated as person's weight in kilograms divided by the square of height in meters.

Trial Locations

Locations (1)

İstanbul Medeniyet University; 🇹🇷 İstanbul, Turkey