Shear Wave Elastography in Adhesive Capsulitis

June 22, 2023 updated by: Mustafa Hüseyin Temel, Uskudar State Hospital

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Üsküdar
      • Istanbul, Üsküdar, Turkey, 34000
        • Üsküdar State Hospital
        • Contact:
        • Principal Investigator:
          • Mustafa H Temel, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients who had a preliminary diagnosis of adhesive capsulitis in Physical Medicine and Rehabilitation or Orthopedics clinic later confirmed by MRI.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Control Group
Individuals who were not suspected of having adhesive capsulitis based on clinical examination and MRI.
Diagnostic test: 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: Sonoelastography
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.
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.
Diagnostic test: 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: Sonoelastography
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uskudar State Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Duzce University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hakan H Soylu, M.D., Düzce University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SWE1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The individual participant data will be shared upon reasonable request by the corresponding author.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings