Adhesive CapsulitisNCT05920239
Shear Wave Elastography in Adhesive Capsulitis
An observational study of Adhesive Capsulitis, run by Uskudar State Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the contribution of sonoelastography in the diagnosis of adhesive capsulitis in patients with a clinical prediagnosis of adhesive capsulitis (AC) and inferior glenohumeral capsuloligamentous complex (IGHCC) involvement demonstrated by magnetic resonance imaging (MRI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Magnetic resonance imaging (MRI) and Sonoelastography
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 1 Nov 2023
- How long will I take part?
- 1 Day
- 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 65 years
- All sexes
- Adult, Older adult
Study population: Patients who had a preliminary diagnosis of adhesive capsulitis in Physical Medicine and Rehabilitation or Orthopedics clinic later confirmed by MRI.
Who may be able to join
- Having a preliminary diagnosis of Adhesive Capsulitis in Physical Medicine and Rehabilitation or Orthopedics clinic and the diagnosis confirmed by MRI
- Giving consent to participate
Who cannot join
- Presence of tumor, arthritis, surgical history, or trauma history in the relevant shoulder joint
- Cervical radiculopathy, a central or peripheral neurological deficit in the upper extremity
- Incomplete sequences or inability to evaluate images due to artifacts in MRI imaging
- Presence of pain and/or limited movement to the extent that it hinders positioning or manipulation for ultrasound examination
- Unwillingness to participate in the study voluntarily
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Üsküdar State Hospital
Istanbul, Üsküdar, 34000
Mustafa H Temel, M.D., 05342714872, mhuseyintemel@gmail.com
Mustafa H Temel, M.D.
About this study
Official title: Assessment of the Involvement of the Inferior Glenohumeral Capsuloligamentous Complex in Adhesive Capsulitis Cases Using Shear Wave Elastography: A Study With Magnetic Resonance Imaging Correlation
This study aimed to evaluate the contribution of sonoelastography in the diagnosis of adhesive capsulitis in patients with a clinical prediagnosis of adhesive capsulitis (AC) and inferior glenohumeral capsuloligamentous complex (IGHCC) involvement demonstrated by magnetic resonance imaging (MRI).
Read the detailed description
The study will include a total of 30 patients who will be diagnosed with AC based on clinical evaluation by physicians from various clinical departments, including physical medicine and rehabilitation, and orthopedics. The diagnosis will be confirmed by two experienced radiologists specializing in musculoskeletal imaging. Based on clinical evaluation and MRI findings, a control group of 34 individuals without suspected AC will be included. MRI imaging will be performed using a 3 Tesla MRI scanner. Sonoelastography will be performed using a Siemens Acuson-S2000 ultrasound device with a 9L4 (4-9 MHz) linear probe and the Virtual Touch Quantification (VTQ/ARFI) method. Shear wave elastography will be applied to the IGHCC to obtain the mean shear wave velocity (SWV) values. The contribution of sonoelastography in the diagnosis of adhesive capsulitis in patients with a clinical prediagnosis of adhesive capsulitis (AC) and inferior glenohumeral capsuloligamentous complex (IGHCC) involvement will be investigated.
- Conditions
- Adhesive Capsulitis
- Being tested
- Magnetic resonance imaging (MRI), Sonoelastography
- Keywords
- Magnetic Resonance Imaging, Shear Wave Elastography
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imaging (MRI)Diagnostic test
MRI imaging is a diagnostic technique that uses magnetic fields and radio waves to create detailed images of the body's internal structures. It provides high-resolution images of soft tissues, organs, and bones, allowing for the detection and evaluation of various medical conditions.Two experienced radiologists specializing in musculoskeletal imaging will evaluate the images obtained through conventional MRI. Cases demonstrating involvement, characterized by findings such as thickening exceeding 4 mm in the inferior glenohumeral capsuloligamentous complex, signal increase indicating edema on fluid-sensitive sequences, and a reduction in axillary recess volume (greater than 0.53 ml), will be included in the study.
SonoelastographyDiagnostic test
Sonoelastography is a medical imaging technique that combines ultrasound imaging with elastography. It is used to assess the mechanical properties and stiffness of tissues in the body.The probe will be carefully positioned perpendicular to the anterior part of the glenohumeral capsuloligamentous complex (IGHCC), ensuring no pressure is applied and preventing anisotropy. It will be specifically oriented in the coronal plane towards the axillary recess. The grayscale examination will reveal irregularly thickened and heterogeneous structures at the axillary recess level in the patient group. On the other hand, in the control group, measurements will be taken from the anterior band of the normal, thin, smooth, and homogeneous structure of the IGHCC.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Individuals who were not suspected of having adhesive capsulitis based on clinical examination and MRI. Receives: Diagnostic Test: Magnetic resonance imaging (MRI); Diagnostic Test: Sonoelastography | |
| Intervention Group | Patients diagnosed with adhesive capsulitis based on evaluations conducted by clinical specialists, primarily in the fields of physical medicine and rehabilitation, orthopedics and traumatology, and confirmed by two experienced radiologists specializing in musculoskeletal imaging through the evaluation of MRI. Receives: Diagnostic Test: Magnetic resonance imaging (MRI); Diagnostic Test: Sonoelastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the Correlation Between MRI Imaging and Sonoelastography Results
This study aims to compare the measurements of intra-articular glenohumeral capsular thickness (IGHCC) using shear wave elastography in two groups: patients with confirmed adhesive capsulitis based on MRI imaging and patients without adhesive capsulitis on MRI imaging. The correlation between the measured shear wave velocity (SWV) values and the diagnosis of adhesive capsulitis will be examined.By comparing the measurements between and within the groups, the correlation of sonoelastography measurements with MRI imaging in healthy individuals and patients will be investigated using statistical methods. Additionally, the potential impact of sonoelastography on the diagnosis of adhesive capsulitis cases will be examined. This study aims to determine the diagnostic value of sonoelastography in adhesive capsulitis and its potential as a complementary tool to MRI.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Uskudar State Hospital
- Sponsor type
- Other government
- Collaborators
- Duzce University
- Responsible party
- Principal investigator, Mustafa Hüseyin Temel, Uskudar State Hospital
- Investigators
- Hakan H Soylu, M.D., Principal investigator, Duzce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920239
- Sponsor's protocol ID
- SWE1
- Status last verified
- Jun 2023
- First submitted
- 14 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The individual participant data will be shared upon reasonable request by the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Involvement of the Inferior Glenohumeral Capsuloligamentous Complex in Adhesive Capsulitis Cases Using Shear Wave Elastography: A Study With Magnetic Resonance Imaging Correlation
- ClinicalTrials.gov ID
- NCT05920239
- Acronym / sponsor ID
- SWE1
- Conditions
- Adhesive Capsulitis
- Keywords
- Magnetic Resonance Imaging, Shear Wave Elastography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Uskudar State HospitalOther government
- Collaborators
- Duzce University
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 27 Jun 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.
This study aimed to evaluate the contribution of sonoelastography in the diagnosis of adhesive capsulitis in patients with a clinical prediagnosis of adhesive capsulitis (AC) and inferior glenohumeral capsuloligamentous complex (IGHCC) involvement demonstrated by magnetic resonance imaging (MRI).
Detailed description
The study will include a total of 30 patients who will be diagnosed with AC based on clinical evaluation by physicians from various clinical departments, including physical medicine and rehabilitation, and orthopedics. The diagnosis will be confirmed by two experienced radiologists specializing in musculoskeletal imaging. Based on clinical evaluation and MRI findings, a control group of 34 individuals without suspected AC will be included. MRI imaging will be performed using a 3 Tesla MRI scanner. Sonoelastography will be performed using a Siemens Acuson-S2000 ultrasound device with a 9L4 (4-9 MHz) linear probe and the Virtual Touch Quantification (VTQ/ARFI) method. Shear wave elastography will be applied to the IGHCC to obtain the mean shear wave velocity (SWV) values. The contribution of sonoelastography in the diagnosis of adhesive capsulitis in patients with a clinical prediagnosis of adhesive capsulitis (AC) and inferior glenohumeral capsuloligamentous complex (IGHCC) involvement will be investigated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Diagnostic Test: Magnetic resonance imaging (MRI), Diagnostic Test: SonoelastographyIndividuals who were not suspected of having adhesive capsulitis based on clinical examination and MRI. |
| Intervention Group | – | Diagnostic Test: Magnetic resonance imaging (MRI), Diagnostic Test: SonoelastographyPatients diagnosed with adhesive capsulitis based on evaluations conducted by clinical specialists, primarily in the fields of physical medicine and rehabilitation, orthopedics and traumatology, and confirmed by two experienced radiologists specializing in musculoskeletal imaging through the evaluation of MRI. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who had a preliminary diagnosis of adhesive capsulitis in Physical Medicine and Rehabilitation or Orthopedics clinic later confirmed by MRI.
Key inclusion criteria (2 listed)
- Having a preliminary diagnosis of Adhesive Capsulitis in Physical Medicine and Rehabilitation or Orthopedics clinic and the diagnosis confirmed by MRI
- Giving consent to participate
Key exclusion criteria (5 listed)
- Presence of tumor, arthritis, surgical history, or trauma history in the relevant shoulder joint
- Cervical radiculopathy, a central or peripheral neurological deficit in the upper extremity
- Incomplete sequences or inability to evaluate images due to artifacts in MRI imaging
- Presence of pain and/or limited movement to the extent that it hinders positioning or manipulation for ultrasound examination
- Unwillingness to participate in the study voluntarily
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 |
|---|---|---|
| Magnetic resonance imaging (MRI)MRI imaging is a diagnostic technique that uses magnetic fields and radio waves to create detailed images of the body's internal structures. It provides high-resolution images of soft tissues, organs, and bones, allowing for the detection and evaluation of various medical conditions.Two experienced radiologists specializing in musculoskeletal imaging will evaluate the images obtained through conventional MRI. Cases demonstrating involvement, characterized by findings such as thickening exceeding 4 mm in the inferior glenohumeral capsuloligamentous complex, signal increase indicating edema on fluid-sensitive sequences, and a reduction in axillary recess volume (greater than 0.53 ml), will be included in the study. | Diagnostic test | Control Group, Intervention Group |
| SonoelastographySonoelastography is a medical imaging technique that combines ultrasound imaging with elastography. It is used to assess the mechanical properties and stiffness of tissues in the body.The probe will be carefully positioned perpendicular to the anterior part of the glenohumeral capsuloligamentous complex (IGHCC), ensuring no pressure is applied and preventing anisotropy. It will be specifically oriented in the coronal plane towards the axillary recess. The grayscale examination will reveal irregularly thickened and heterogeneous structures at the axillary recess level in the patient group. On the other hand, in the control group, measurements will be taken from the anterior band of the normal, thin, smooth, and homogeneous structure of the IGHCC. | Diagnostic test | Control Group, Intervention Group |
Primary outcome
Measuring the Correlation Between MRI Imaging and Sonoelastography Results
Time frame: 1 day
This study aims to compare the measurements of intra-articular glenohumeral capsular thickness (IGHCC) using shear wave elastography in two groups: patients with confirmed adhesive capsulitis based on MRI imaging and patients without adhesive capsulitis on MRI imaging. The correlation between the measured shear wave velocity (SWV) values and the diagnosis of adhesive capsulitis will be examined.By comparing the measurements between and within the groups, the correlation of sonoelastography measurements with MRI imaging in healthy individuals and patients will be investigated using statistical methods. Additionally, the potential impact of sonoelastography on the diagnosis of adhesive capsulitis cases will be examined. This study aims to determine the diagnostic value of sonoelastography in adhesive capsulitis and its potential as a complementary tool to MRI.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: Undecided. The individual participant data will be shared upon reasonable request by the corresponding author.
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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.
Hakan H Soylu, M.D. principal investigator
Duzce University
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 Adhesive Capsulitis, run by Uskudar State Hospital 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hakan H Soylu, M.D. (+905398448025, huseyin.soylu.91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring the Correlation Between MRI Imaging and Sonoelastography Results (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2023.