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.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
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
3
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
4
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
5
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
Trial details
NCT IDNCT05403424
SponsorSultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey