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

Not yet recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

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 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

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
Intervention / Treatment
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

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

Uskudar State Hospital

Collaborators

Duzce University

Investigators

  • Principal Investigator: Hakan H Soylu, M.D., Duzce 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)

July 1, 2023

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

November 1, 2023

Study Registration Dates

First Submitted

June 14, 2023

First Submitted That Met QC Criteria

June 22, 2023

First Posted (Actual)

June 27, 2023

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 22, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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