Pregnant WomenNCT05335330
Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnant Women
An observational study of Pregnant Women and First Pregnancy, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
Pregnancy causes the development of biomechanical adaptations in the musculoskeletal system, especially in the lumbopelvic region. In this context, the thoracolumbar fascia (TLF) is the most important structure in this region and is an exoskeleton for the muscles of the lumbar region. 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, First Pregnancy
- What is being tested?
- Evaluation of biomechanics and viscoelastic properties of Thoracolumbar fascia
- How many people
- 145 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 9 Jan 2024
- 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 (first pregnancy)
Who may be able to join
- First pregnancy
- They are between the ages of 18-40
- 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 in biomechanical alignment
- History of spine, pelvis or lower extremity surgery or fracture in the past 6 months
- Description of chronic (more than 3 months) lumbar-pelvic region pain before pregnancy
- Defining metabolic disorders such as type I, II diabetes, gestational diabetes mellitus (GDM), preeclampsia
- Having Pelvic Girdle Pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Trimester-Specific Normative Values of Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnant Women
Pregnancy causes the development of biomechanical adaptations in the musculoskeletal system, especially in the lumbopelvic region. In this context, the thoracolumbar fascia (TLF) is the most important structure in this region and is an exoskeleton for the muscles of the lumbar region. However, it has not been objectively clarified how the TLF adapts to the changes in the lumbopelvic region during pregnancy. Therefore, the aim of this pilot study is to investigate the trimester-specific biomechanical (stiffness, decrement and tone) and viscoelastic (creep and relaxation time) properties of the TLF, which adapts to the lumbopelvic region changes in pregnant women.
- Conditions
- Pregnant Women, First Pregnancy
- Being tested
- Evaluation of biomechanics and viscoelastic properties of Thoracolumbar fascia
- Keywords
- pregnant women, thoracolumbar fascia, stiffness, creep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of biomechanics and viscoelastic properties of Thoracolumbar fasciaOther
The biomechanical and viscoelastic properties of the Thoracolumbar fascia will be measured in the side line position. Measurements will be taken from three different points; L1, L3-4 and L5 level.
| Study group | Role | What they receive |
|---|---|---|
| First trimester pregnant women (first pregnancy) | Pregnant women who are in their first pregnancy and in their first trimester will be evaluated. Receives: Other: Evaluation of biomechanics and viscoelastic properties of Thoracolumbar fascia | |
| Second trimester pregnant women (first pregnancy) | Pregnant women who are in their first pregnancy and in their second trimester will be evaluated. Receives: Other: Evaluation of biomechanics and viscoelastic properties of Thoracolumbar fascia | |
| Third trimester pregnant women (first pregnancy) | Pregnant women who are in their first pregnancy and in their third trimester will be evaluated. 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 side line position.
Measured: Measurement the baseline stiffness values of Thoracolumbar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Evaluation of viscoelastic properties of thoracolumbar fascia
Measuring of the relaxation time (ms) of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side line position.
Measured: Measurement the baseline relaxation time values of Thoracolumbar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Evaluation of biomechanical properties of thoracolumbar fascia
Measuring of the tone (Hz) of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side line position.
Measured: Measurement the baseline tone values of Thoracolumbar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Evaluation of viscoelastic properties of thoracolumbar fascia
Measuring of the creep of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side line position.
Measured: Measurement the baseline creep values of Thoracolumb Measurement the baseline creep values of Thoracolumbar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Evaluation of biomechanical properties of thoracolumbar fascia
Measuring of the decrement of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side line position.
Measured: Measurement the baseline decrement values of Thoracolumbar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Secondary outcomes (2)
Evaluation of Body Weight
Measuring of the Body Weight
Measured: Measurement the baseline body weight (kg) at evaluation time
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 baseline BMI values at evaluation time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start1 Jun 2022
- Primary completion9 Jan 2024
- Study completion9 Jan 2024
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
- 145 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
- NCT05335330
- Sponsor's protocol ID
- 34 09/03/2022
- Status last verified
- Sep 2024
- First submitted
- 12 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
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.
PubMed 29679246Hu X, Lei D, Li L, Leng Y, Yu Q, Wei X, Lo WLA. Quantifying paraspinal muscle tone and stiffness in young adults with chronic low back pain: a reliability study. Sci Rep. 2018 Sep 25;8(1):14343. doi: 10.1038/s41598-018-32418-x.
PubMed 30254233Tincello DG, Teare J, Fraser WD. Second trimester concentration of relaxin and pregnancy related incontinence. Eur J Obstet Gynecol Reprod Biol. 2003 Feb 10;106(2):237-8. doi: 10.1016/s0301-2115(02)00360-3. No abstract available.
PubMed 12551802Wu 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 34616306Sanjana F, Chaudhry H, Findley T. Effect of MELT method on thoracolumbar connective tissue: The full study. J Bodyw Mov Ther. 2017 Jan;21(1):179-185. doi: 10.1016/j.jbmt.2016.05.010. Epub 2016 Jun 3.
PubMed 28167175
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 Trimester-Specific Normative Values of Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnant Women
- ClinicalTrials.gov ID
- NCT05335330
- Acronym / sponsor ID
- 34 09/03/2022
- Conditions
- Pregnant Women, First Pregnancy
- Keywords
- pregnant women, thoracolumbar fascia, stiffness, creep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- 9 Jan 2024 (actual)
- First posted
- 19 Apr 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.
Pregnancy causes the development of biomechanical adaptations in the musculoskeletal system, especially in the lumbopelvic region. In this context, the thoracolumbar fascia (TLF) is the most important structure in this region and is an exoskeleton for the muscles of the lumbar region. However, it has not been objectively clarified how the TLF adapts to the changes in the lumbopelvic region during pregnancy. Therefore, the aim of this pilot study is to investigate the trimester-specific biomechanical (stiffness, decrement and tone) and viscoelastic (creep and relaxation time) properties of the TLF, which adapts to the lumbopelvic region changes in pregnant women.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| First trimester pregnant women (first pregnancy) | – | Other: Evaluation of biomechanics and viscoelastic properties of Thoracolumbar fasciaPregnant women who are in their first pregnancy and in their first trimester will be evaluated. |
| Second trimester pregnant women (first pregnancy) | – | Other: Evaluation of biomechanics and viscoelastic properties of Thoracolumbar fasciaPregnant women who are in their first pregnancy and in their second trimester will be evaluated. |
| Third trimester pregnant women (first pregnancy) | – | Other: Evaluation of biomechanics and viscoelastic properties of Thoracolumbar fasciaPregnant women who are in their first pregnancy and in their third trimester will be evaluated. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women (first pregnancy)
Key inclusion criteria (3 listed)
- First pregnancy
- They are between the ages of 18-40
- Pre-pregnancy Body-Mass-Index (BMI) \< 30 kg/m2
Key exclusion criteria (7 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 in biomechanical alignment
- History of spine, pelvis or lower extremity surgery or fracture in the past 6 months
- Description of chronic (more than 3 months) lumbar-pelvic region pain 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 biomechanics and viscoelastic properties of Thoracolumbar fasciaThe biomechanical and viscoelastic properties of the Thoracolumbar fascia will be measured in the side line position. Measurements will be taken from three different points; L1, L3-4 and L5 level. | Other | First trimester pregnant women (first pregnancy), Second trimester pregnant women (first pregnancy), Third trimester pregnant women (first pregnancy) |
Primary outcome
Evaluation of biomechanical properties of thoracolumbar fascia
Time frame: Measurement the baseline stiffness values of Thoracolumbar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Measuring of the stiffness (N/m) of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side line position.
Evaluation of viscoelastic properties of thoracolumbar fascia
Time frame: Measurement the baseline relaxation time values of Thoracolumbar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Measuring of the relaxation time (ms) of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side line position.
Evaluation of biomechanical properties of thoracolumbar fascia
Time frame: Measurement the baseline tone values of Thoracolumbar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Measuring of the tone (Hz) of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side line position.
Evaluation of viscoelastic properties of thoracolumbar fascia
Time frame: Measurement the baseline creep values of Thoracolumb Measurement the baseline creep values of Thoracolumbar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Measuring of the creep of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side line position.
Evaluation of biomechanical properties of thoracolumbar fascia
Time frame: Measurement the baseline decrement values of Thoracolumbar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks
Measuring of the decrement of the thoracolumbar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side line position.
2 secondary outcomes
Evaluation of Body Weight
Time frame: Measurement the baseline body weight (kg) at evaluation time
Evaluation of Body Mass Index (BMI)
Time frame: Measurement the baseline BMI values at evaluation time
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 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 30254233Hu X, Lei D, Li L, Leng Y, Yu Q, Wei X, Lo WLA. Quantifying paraspinal muscle tone and stiffness in young adults with chronic low back pain: a reliability study. Sci Rep. 2018 Sep 25;8(1):14343. doi: 10.1038/s41598-018-32418-x.
- Results publication: PubMed 12551802Tincello DG, Teare J, Fraser WD. Second trimester concentration of relaxin and pregnancy related incontinence. Eur J Obstet Gynecol Reprod Biol. 2003 Feb 10;106(2):237-8. doi: 10.1016/s0301-2115(02)00360-3. No abstract available.
- 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 28167175Sanjana F, Chaudhry H, Findley T. Effect of MELT method on thoracolumbar connective tissue: The full study. J Bodyw Mov Ther. 2017 Jan;21(1):179-185. doi: 10.1016/j.jbmt.2016.05.010. Epub 2016 Jun 3.
- 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 First Pregnancy, 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 3 inclusion and 7 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 baseline stiffness values of Thoracolumbar fascia between 10-14 weeks, between 20-24 weeks and between 32-36 weeks). 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 NCT05335330, 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.