Shear-wave Elastography of Hip Stabilizers in Healthy IndividualsNCT06157775
Shear-wave Elastography of Hip Stabilizers in Healthy Individuals
An observational study of Shear-wave Elastography of Hip Stabilizers in Healthy Individuals, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to provide a scientific basis for Shear-wave elastography measurements of hip stabilizing muscles on healthy individuals. To assess the inter- and intra-user validity, 12 healthy volunteers were recruited for ultrasonographic assessment by two experienced physiatrists. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Shear-wave Elastography of Hip Stabilizers in Healthy Individuals
- What is being tested?
- Shear-wave elastography
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Oct 2019to 31 Dec 2019
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 12 Healthy Individuals, 4 male and 8 female.
Who may be able to join
- Healthy Individuals
- Age 18-30 years
- Volunteering for the study
- Absence of musculoskeletal pathologies involving pelvic, hip, and/or knee joints.
Who cannot join
- Recent complaints of pelvic, hip, and/or knee pain.
- Previous history of trauma or surgery, including the lumbar, pelvic, hip, or knee region.
- Congenital or acquired pathologies of pelvis or lower extremity.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Koc University School of Medicine
Istanbul, 34010
About this study
Official title: Reliability of Ultrasound Shear-wave Elastography in Assessing Tensor Fascia Lata, Gluteus Medius, and Iliotibial Band Elasticity in Health Individuals: a Cross-sectional Study.
The aim of this study is to provide a scientific basis for Shear-wave elastography measurements of hip stabilizing muscles on healthy individuals. To assess the inter- and intra-user validity, 12 healthy volunteers were recruited for ultrasonographic assessment by two experienced physiatrists.
- Being tested
- Shear-wave elastography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shear-wave elastographyDiagnostic test
Shear-wave elastography using a manual ultrasound with a 9L-Probe in B-mode.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Individuals | Not described Receives: Diagnostic Test: Shear-wave elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of tensor fascia latae muscle on shear wave elastography.
Measured: 1 month
Assessment of gluteus medius muscle on shear wave elastography.
Measured: 1 month
Assessment of iliotibial band on shear wave elastography.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start31 Oct 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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 Shear-wave Elastography of Hip Stabilizers in Healthy IndividualsStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ozden Ozyemisci Taskiran, MD, Principal investigator, Koc University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157775
- Sponsor's protocol ID
- 2019.347.IRB1.062
- Status last verified
- Oct 2019
- First submitted
- 20 Nov 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cortez CD, Hermitte L, Ramain A, Mesmann C, Lefort T, Pialat JB. Ultrasound shear wave velocity in skeletal muscle: A reproducibility study. Diagn Interv Imaging. 2016 Jan;97(1):71-9. doi: 10.1016/j.diii.2015.05.010. Epub 2015 Jun 25.
PubMed 26119864Iida N, Kuroiwa T, Amadio P. Analysis of the thenar muscles with ultrasound shear wave elastography: Reliability and preliminary findings. Muscle Nerve. 2024 Jan;69(1):72-77. doi: 10.1002/mus.28004. Epub 2023 Nov 15.
PubMed 37964671Whittaker JL, Emery CA. Sonographic measures of the gluteus medius, gluteus minimus, and vastus medialis muscles. J Orthop Sports Phys Ther. 2014 Aug;44(8):627-32. doi: 10.2519/jospt.2014.5315. Epub 2014 Jul 16.
PubMed 25029916Vuorenmaa AS, Siitama EMK, Makela KS. Inter-operator and inter-device reproducibility of shear wave elastography in healthy muscle tissues. J Appl Clin Med Phys. 2022 Sep;23(9):e13717. doi: 10.1002/acm2.13717. Epub 2022 Jul 6.
PubMed 35793227Gyaran IA, Spiezia F, Hudson Z, Maffulli N. Sonographic measurement of iliotibial band thickness: an observational study in healthy adult volunteers. Knee Surg Sports Traumatol Arthrosc. 2011 Mar;19(3):458-61. doi: 10.1007/s00167-010-1269-z. Epub 2010 Oct 2.
PubMed 20890700
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Ultrasound Shear-wave Elastography in Assessing Tensor Fascia Lata, Gluteus Medius, and Iliotibial Band Elasticity in Health Individuals: a Cross-sectional Study.
- ClinicalTrials.gov ID
- NCT06157775
- Acronym / sponsor ID
- 2019.347.IRB1.062
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 6 Dec 2023 (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.
The aim of this study is to provide a scientific basis for Shear-wave elastography measurements of hip stabilizing muscles on healthy individuals. To assess the inter- and intra-user validity, 12 healthy volunteers were recruited for ultrasonographic assessment by two experienced physiatrists.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Individuals | – | Diagnostic Test: Shear-wave elastography |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 12 Healthy Individuals, 4 male and 8 female.
Key inclusion criteria (4 listed)
- Healthy Individuals
- Age 18-30 years
- Volunteering for the study
- Absence of musculoskeletal pathologies involving pelvic, hip, and/or knee joints.
Key exclusion criteria (3 listed)
- Recent complaints of pelvic, hip, and/or knee pain.
- Previous history of trauma or surgery, including the lumbar, pelvic, hip, or knee region.
- Congenital or acquired pathologies of pelvis or lower extremity.
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 |
|---|---|---|
| Shear-wave elastographyShear-wave elastography using a manual ultrasound with a 9L-Probe in B-mode. | Diagnostic test | Healthy Individuals |
Primary outcome
Assessment of tensor fascia latae muscle on shear wave elastography.
Time frame: 1 month
Assessment of gluteus medius muscle on shear wave elastography.
Time frame: 1 month
Assessment of iliotibial band on shear wave elastography.
Time frame: 1 month
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 6 Dec 2023.
- Background: PubMed 26119864Cortez CD, Hermitte L, Ramain A, Mesmann C, Lefort T, Pialat JB. Ultrasound shear wave velocity in skeletal muscle: A reproducibility study. Diagn Interv Imaging. 2016 Jan;97(1):71-9. doi: 10.1016/j.diii.2015.05.010. Epub 2015 Jun 25.
- Background: PubMed 37964671Iida N, Kuroiwa T, Amadio P. Analysis of the thenar muscles with ultrasound shear wave elastography: Reliability and preliminary findings. Muscle Nerve. 2024 Jan;69(1):72-77. doi: 10.1002/mus.28004. Epub 2023 Nov 15.
- Background: PubMed 25029916Whittaker JL, Emery CA. Sonographic measures of the gluteus medius, gluteus minimus, and vastus medialis muscles. J Orthop Sports Phys Ther. 2014 Aug;44(8):627-32. doi: 10.2519/jospt.2014.5315. Epub 2014 Jul 16.
- Background: PubMed 35793227Vuorenmaa AS, Siitama EMK, Makela KS. Inter-operator and inter-device reproducibility of shear wave elastography in healthy muscle tissues. J Appl Clin Med Phys. 2022 Sep;23(9):e13717. doi: 10.1002/acm2.13717. Epub 2022 Jul 6.
- Background: PubMed 20890700Gyaran IA, Spiezia F, Hudson Z, Maffulli N. Sonographic measurement of iliotibial band thickness: an observational study in healthy adult volunteers. Knee Surg Sports Traumatol Arthrosc. 2011 Mar;19(3):458-61. doi: 10.1007/s00167-010-1269-z. Epub 2010 Oct 2.
- Individual participant dataSharing planned: No
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.
Ozden Ozyemisci Taskiran, MD principal investigator
Koc University Hospital
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 Shear-wave Elastography of Hip Stabilizers in Healthy Individuals, run by Koç University 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 4 inclusion and 3 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 6 Dec 2023. 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?
Assessment of tensor fascia latae muscle on shear wave elastography. (time frame: 1 month). The study lists 3 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 NCT06157775, 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 6 Dec 2023.