Shear Wave Elastography in Adhesive Capsulitis

NCT05920239 | Unknown

• 1 other identifier: SWE1
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Adhesive Capsulitis

Keywords

Magnetic Resonance Imaging; Shear Wave Elastography

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Study Arms (2)

Control Group

Individuals who were not suspected of having adhesive capsulitis based on clinical examination and MRI.

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.

Diagnostic Test: Magnetic resonance imaging (MRI); Diagnostic Test: Sonoelastography

Interventions

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.

Control Group; Intervention Group

Sonoelastography DIAGNOSTIC_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.

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uskudar State Hospital: lead
• Duzce University: collaborator

Study Sites (1)

Üsküdar State Hospital

Istanbul, Üsküdar, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bursitis

Interventions

Magnetic Resonance Imaging; Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography

Study Officials

• Hakan H Soylu, M.D.

  Duzce University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hakan H Soylu, M.D.

CONTACT

+905398448025; huseyin.soylu.91@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 27, 2023
• Study Start: July 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: November 1, 2023
• Last Updated: June 27, 2023

Record last verified: 2023-06

Locations

TU (1)