Pregnant WomenNCT05403424
Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnancy Pelvic Girdle Pain
An observational study of Pregnant Women and Pelvic Girdle Pain, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women, Pelvic Girdle Pain
- What is being tested?
- Evaluation of pain, Application of pelvic girdle diagnostic tests and Evaluation of biomechanics and viscoelastic properties of thoracolumbar fascia
- How many people
- 103 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 15 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women with and without PGP and non-pregnant women
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnant Women With Pelvic Girdle Pain
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.
- Conditions
- Pregnant Women, Pelvic Girdle Pain
- Being tested
- Evaluation of pain, Application of pelvic girdle diagnostic tests, Evaluation of biomechanics and viscoelastic properties of thoracolumbar fascia, Evaluation of activity limitation
- Keywords
- pregnant women, pelvic girdle pain, thoracolumbar fascia, stiffness, creep
- Medical subject headings
- Pelvic Girdle Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of painOther
The severity of pelvic girdle pain will be evaluated with the Visual Analog Scale (VAS).
Application of pelvic girdle diagnostic testsDiagnostic test
Pelvic girdle pain diagnostic tests will be applied.
Evaluation of biomechanics and viscoelastic properties of thoracolumbar fasciaOther
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 limitationOther
Pelvic Girdle Questionnaire will be filled
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Pregnant women with pelvic girdle pain | This group will consist of pregnant women diagnosed with pelvic girdle pain. Receives: 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 | |
| Group 2: Pregnant women without pelvic girdle pain | This group will consist of pregnant women who do not have pelvic girdle pain. Receives: 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 | |
| Group 3: Non-pregnant women | This group will consist of non-pregnant women. Receives: Other: Evaluation of biomechanics and viscoelastic properties of thoracolumbar fascia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of biomechanical properties of thoracolumbar fascia
Measuring of the stiffness (N/m) of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.
Measured: Measurement the change from baseline stiffness values of Thoracolumbar fascia at 12. week and at 22. week
Evaluation of biomechanical properties of thoracolumbar fascia
Measuring of the decrement of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.
Measured: Measurement the change from baseline decrement values of Thoracolumbar fascia at 12. week and at 22. week
Evaluation of biomechanical properties of thoracolumbar fascia
Measuring of the tone (Hz) of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.
Measured: Measurement the change from baseline tone values of Thoracolumbar fascia at 12. week and at 22. week
Evaluation of viscoelastic properties of thoracolumbar fascia
Measuring of the creep of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.
Measured: Measurement the change from baseline creep values of Thoracolumbar fascia at 12. week and at 22. week
Evaluation of viscoelastic properties of thoracolumbar fascia
Measuring of thethe relaxation time (ms) of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.
Measured: Measurement the change from baseline relaxation time values of Thoracolumbar fascia at 12. week and at 22. week
Secondary outcomes (6)
Determining of painful areas
Marking of body chart
Measured: Baseline
Evaluation of pain
Pain will be evaluated with Visual analog scale (VAS). The VAS is scaled between 0-10 points (0: no pain, 10: most severe pain).
Measured: Baseline
Application of Pelvic Girdle Pain (PGP) diagnostic tests
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.
Measured: Baseline
Pelvic Girdle Questionnaire
Activity limitation will be evaluated Pelvic Girdle Questionnaire
Measured: Baseline
Evaluation of Body Weight
Measuring of the Body Weight
Measured: Measurement the change from baseline body weight (kg) at 12. and 22. weeks.
Evaluation of Body Mass Index (BMI)
BMI (kg/m2) will be calculated as person's weight in kilograms divided by the square of height in meters.
Measured: Measurement the change from baseline BMI values at 12.and 22. weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Jun 2022
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403424
- Sponsor's protocol ID
- 33 09/03/2022
- Status last verified
- Jul 2026
- First submitted
- 15 Apr 2022
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35204392Aldabe 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.
PubMed 32560861Lohr 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.
PubMed 29679246Wu 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.
PubMed 34616306Stuge 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.
PubMed 21596959
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnant Women With Pelvic Girdle Pain
- ClinicalTrials.gov ID
- NCT05403424
- Acronym / sponsor ID
- 33 09/03/2022
- Conditions
- Pregnant Women, Pelvic Girdle Pain
- Keywords
- pregnant women, pelvic girdle pain, thoracolumbar fascia, stiffness, creep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Pregnant women with pelvic girdle pain | – | 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 limitationThis group will consist of pregnant women diagnosed with pelvic girdle pain. |
| Group 2: Pregnant women without pelvic girdle pain | – | 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 limitationThis group will consist of pregnant women who do not have pelvic girdle pain. |
| Group 3: Non-pregnant women | – | Other: Evaluation of biomechanics and viscoelastic properties of thoracolumbar fasciaThis group will consist of non-pregnant women. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women with and without PGP and non-pregnant women
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of painThe severity of pelvic girdle pain will be evaluated with the Visual Analog Scale (VAS). | Other | Group 1: Pregnant women with pelvic girdle pain, Group 2: Pregnant women without pelvic girdle pain |
| Application of pelvic girdle diagnostic testsPelvic girdle pain diagnostic tests will be applied. | Diagnostic test | Group 1: Pregnant women with pelvic girdle pain, Group 2: Pregnant women without pelvic girdle pain |
| Evaluation of biomechanics and viscoelastic properties of thoracolumbar fasciaThe biomechanical and viscoelastic properties of the thoracolumbar fascia will be measured in the prone position and measurements will be taken from three different points | Other | Group 1: Pregnant women with pelvic girdle pain, Group 2: Pregnant women without pelvic girdle pain, Group 3: Non-pregnant women |
| Evaluation of activity limitationPelvic Girdle Questionnaire will be filled | Other | Group 1: Pregnant women with pelvic girdle pain, Group 2: Pregnant women without pelvic girdle pain |
Primary outcome
Evaluation of biomechanical properties of thoracolumbar fascia
Time frame: Measurement the change from baseline stiffness values of Thoracolumbar fascia at 12. week and at 22. week
Measuring of the stiffness (N/m) of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.
Evaluation of biomechanical properties of thoracolumbar fascia
Time frame: Measurement the change from baseline decrement values of Thoracolumbar fascia at 12. week and at 22. week
Measuring of the decrement of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.
Evaluation of biomechanical properties of thoracolumbar fascia
Time frame: 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
Time frame: Measurement the change from baseline creep values of Thoracolumbar fascia at 12. week and at 22. week
Measuring of the creep of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the prone position.
Evaluation of viscoelastic properties of thoracolumbar fascia
Time frame: 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.
6 secondary outcomes
Determining of painful areas
Time frame: Baseline
Evaluation of pain
Time frame: Baseline
Application of Pelvic Girdle Pain (PGP) diagnostic tests
Time frame: Baseline
Pelvic Girdle Questionnaire
Time frame: Baseline
Evaluation of Body Weight
Time frame: Measurement the change from baseline body weight (kg) at 12. and 22. weeks.
Evaluation of Body Mass Index (BMI)
Time frame: Measurement the change from baseline BMI values at 12.and 22. weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Results publication: PubMed 35204392Alcaraz-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.
- Results publication: PubMed 32560861Aldabe 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.
- Results publication: PubMed 29679246Lohr 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.
- Results publication: PubMed 34616306Wu 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.
- Results publication: PubMed 21596959Stuge 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant Women and Pelvic Girdle Pain, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of biomechanical properties of thoracolumbar fascia (time frame: Measurement the change from baseline stiffness values of Thoracolumbar fascia at 12. week and at 22. week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05403424, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.