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

NCT ID: NCT05403424

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2025-10-15

Brief Summary

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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

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Conditions

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Pregnant Women Pelvic Girdle Pain

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group 1: Pregnant women with pelvic girdle pain

This group will consist of pregnant women diagnosed with pelvic girdle pain.

Evaluation of pain

Intervention Type OTHER

The severity of pelvic girdle pain will be evaluated with the Visual Analog Scale (VAS).

Application of pelvic girdle diagnostic tests

Intervention Type DIAGNOSTIC_TEST

Pelvic girdle pain diagnostic tests will be applied.

Evaluation of biomechanics and viscoelastic properties of thoracolumbar fascia

Intervention Type OTHER

The biomechanical and viscoelastic properties of the thoracolumbar fascia will be measured in the prone position and measurements will be taken from three different points

Evaluation of activity limitation

Intervention Type OTHER

Pelvic Girdle Questionnaire will be filled

Group 2: Pregnant women without pelvic girdle pain

This group will consist of pregnant women who do not have pelvic girdle pain.

Evaluation of pain

Intervention Type OTHER

The severity of pelvic girdle pain will be evaluated with the Visual Analog Scale (VAS).

Application of pelvic girdle diagnostic tests

Intervention Type DIAGNOSTIC_TEST

Pelvic girdle pain diagnostic tests will be applied.

Evaluation of biomechanics and viscoelastic properties of thoracolumbar fascia

Intervention Type OTHER

The biomechanical and viscoelastic properties of the thoracolumbar fascia will be measured in the prone position and measurements will be taken from three different points

Evaluation of activity limitation

Intervention Type OTHER

Pelvic Girdle Questionnaire will be filled

Group 3: Non-pregnant women

This group will consist of non-pregnant women.

Evaluation of biomechanics and viscoelastic properties of thoracolumbar fascia

Intervention Type OTHER

The biomechanical and viscoelastic properties of the thoracolumbar fascia will be measured in the prone position and measurements will be taken from three different points

Interventions

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Evaluation of pain

The severity of pelvic girdle pain will be evaluated with the Visual Analog Scale (VAS).

Intervention Type OTHER

Application of pelvic girdle diagnostic tests

Pelvic girdle pain diagnostic tests will be applied.

Intervention Type DIAGNOSTIC_TEST

Evaluation of biomechanics and viscoelastic properties of thoracolumbar fascia

The biomechanical and viscoelastic properties of the thoracolumbar fascia will be measured in the prone position and measurements will be taken from three different points

Intervention Type OTHER

Evaluation of activity limitation

Pelvic Girdle Questionnaire will be filled

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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İstanbul Medeniyet University

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Nilüfer KABLAN, PhD

Role: CONTACT

05067638556

Merve Can, Msc

Role: CONTACT

05388397713

Facility Contacts

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Nilüfer KABLAN, PHD

Role: primary

05067638556

References

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Alcaraz-Clariana S, Garcia-Luque L, Garrido-Castro JL, Carmona-Perez C, Rodrigues-de-Souza DP, Fernandez-de-Las-Penas C, Alburquerque-Sendin F. Influence of Spinal Movements Associated with Physical Evaluation on Muscle Mechanical Properties of the Lumbar Paraspinal in Subjects with Acute Low Back Pain. Diagnostics (Basel). 2022 Jan 25;12(2):302. doi: 10.3390/diagnostics12020302.

Reference Type RESULT
PMID: 35204392 (View on PubMed)

Aldabe D, Milosavljevic S, Bussey MD. A multivariate model for predicting PPGP considering postural adjustment parameters. Musculoskelet Sci Pract. 2020 Aug;48:102153. doi: 10.1016/j.msksp.2020.102153. Epub 2020 May 5.

Reference Type RESULT
PMID: 32560861 (View on PubMed)

Lohr C, Braumann KM, Reer R, Schroeder J, Schmidt T. Reliability of tensiomyography and myotonometry in detecting mechanical and contractile characteristics of the lumbar erector spinae in healthy volunteers. Eur J Appl Physiol. 2018 Jul;118(7):1349-1359. doi: 10.1007/s00421-018-3867-2. Epub 2018 Apr 20.

Reference Type RESULT
PMID: 29679246 (View on PubMed)

Wu Z, Wang Y, Ye Z, Guan Y, Ye X, Chen Z, Li C, Chen G, Zhu Y, Du J, Chen G, Liu W, Xu X. Effects of Age and Sex on Properties of Lumbar Erector Spinae in Healthy People: Preliminary Results From a Pilot Study. Front Physiol. 2021 Sep 20;12:718068. doi: 10.3389/fphys.2021.718068. eCollection 2021.

Reference Type RESULT
PMID: 34616306 (View on PubMed)

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.

Reference Type RESULT
PMID: 21596959 (View on PubMed)

Other Identifiers

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33 09/03/2022

Identifier Type: -

Identifier Source: org_study_id

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