Actively Recruiting

Age: 18Years - 40Years
FEMALE
Healthy Volunteers
ID05403424

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

Led by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Updated on 2024-09-19

60

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how the thoracolumbar fascia (TLF), a connective tissue in the lower back, changes during pregnancy and how these changes relate to pelvic girdle pain (PGP). The study aims to understand the biomechanical and viscoelastic properties of TLF in pregnant women with and without PGP, as well as in non-pregnant women, to clarify the connection between TLF adaptations and pelvic pain. The study includes three groups: pregnant women with pelvic girdle pain, pregnant women without pelvic girdle pain, and non-pregnant women. Researchers will measure the biomechanical properties of TLF, such as stiffness, tone, and relaxation, at baseline and again at 12 and 22 weeks. They will also assess pain severity using the Visual Analog Scale, apply pelvic girdle diagnostic tests, and collect data through questionnaires like the Pelvic Girdle Questionnaire. Participants will undergo evaluations including biomechanical measurements taken in a prone position from three points on the TLF, pain assessments, and diagnostic tests to identify PGP. Body weight and body mass index will be tracked at the same intervals. The primary outcomes focus on changes in stiffness, tone, and viscoelastic properties of TLF, while secondary outcomes include pain levels and activity limitations. The study is observational and led by Sultan Abdulhamid Han Training and Research Hospital in Istanbul, Turkey.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 40Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • First-time pregnancy
  • Pregnant women diagnosed with pelvic girdle pain in 1st and 2nd trimesters
  • Pregnant women without pelvic girdle pain in 1st and 2nd trimesters
  • Women who are not pregnant
  • Pre-pregnancy Body-Mass-Index (BMI) less than 30 kg/m2
Not Eligible

You will not qualify if you...

  • Connective tissue disease present
  • Skin integrity problems in measurement areas
  • Orthopedic, neurological, or rheumatic problems affecting musculoskeletal alignment
  • History of spine, pelvis, or lower limb surgery or fracture within past 6 months
  • Chronic low back-pelvic pain lasting more than 3 months with severity over 4 on pain scale before pregnancy
  • Metabolic disorders such as Type I or II diabetes, gestational diabetes, or preeclampsia before or during pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline

Participants undergo pelvic girdle pain diagnostic tests and evaluation of painful areas and pain severity.

1 visit (in-person)

Monitoring

Duration - 22 weeks

Participants are observed with repeated measurements of biomechanical and viscoelastic properties of the thoracolumbar fascia, body weight, and BMI at 12 and 22 weeks.

3 visits (baseline, 12 weeks, and 22 weeks)

Trial Site Locations

Total: 1 location

1

İstanbul Medeniyet University

Istanbul, Turkey (Türkiye)

Actively Recruiting

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Research Team

N

Nilüfer KABLAN, PhD

M

Merve Can, Msc

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

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Sandra Alcaraz-Clariana, Lourdes García-Luque, Juan Luis Garrido-Castro...

https://pubmed.ncbi.nlm.nih.gov/35204392

Reliability of tensiomyography and myotonometry in detecting mechanical and contractile characteristics of the lumbar erector spinae in healthy volunteers.

Christine Lohr, Klaus-Michael Braumann, Ruediger Reer...

https://pubmed.ncbi.nlm.nih.gov/29679246

The pelvic girdle questionnaire: a condition-specific instrument for assessing activity limitations and symptoms in people with pelvic girdle pain.

Britt Stuge, Andrew Garratt, Hanne Krogstad Jenssen...

https://pubmed.ncbi.nlm.nih.gov/21596959