Examining the thoracolumbar fascia in pregnant women with pelvic girdle pain
Investigation of Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnant Women With Pelvic Girdle Pain
This study looks at how the thoracolumbar fascia changes during pregnancy in women with pelvic girdle pain compared to those without pain to help understand and manage this discomfort better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT05403424 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how the thoracolumbar fascia (TLF) adapts biomechanically and viscoelastically during pregnancy, particularly in relation to pelvic girdle pain (PGP). It will evaluate the properties of the TLF in pregnant women experiencing PGP and compare them to those without pain. The study will involve assessments of pain, pelvic girdle diagnostic tests, and biomechanical evaluations to understand the relationship between TLF changes and PGP. The findings could provide insights into the management of pelvic girdle pain in pregnant women.
Who should consider this trial
Good fit: Ideal candidates include first-time pregnant women in their 1st or 2nd trimesters, both with and without pelvic girdle pain.
Not a fit: Patients with chronic low back-pelvic pain prior to pregnancy or those with certain medical conditions such as connective tissue diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management strategies for pelvic girdle pain in pregnant women.
How similar studies have performed: While the specific approach of this study may be novel, similar studies have explored the biomechanics of pregnancy-related conditions, indicating potential for valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Istanbul
- İstanbul Medeniyet University — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Nilüfer KABLAN, PhD
- Email: niluferkablan@yahoo.com
- Phone: 05067638556
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.