Shear Wave Elastography in Adhesive Capsulitis

NCT ID: NCT05920239

Last Updated: 2023-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2023-11-01

Brief Summary

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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

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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

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Adhesive Capsulitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control Group

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

Magnetic resonance imaging (MRI)

Intervention Type 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.

Sonoelastography

Intervention Type 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.

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.

Magnetic resonance imaging (MRI)

Intervention Type 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.

Sonoelastography

Intervention Type 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.

Interventions

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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.

Intervention Type 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 Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duzce University

OTHER

Sponsor Role collaborator

Uskudar State Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mustafa Hüseyin Temel

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hakan H Soylu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Duzce University

Locations

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Üsküdar State Hospital

Istanbul, Üsküdar, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Hakan H Soylu, M.D.

Role: CONTACT

+905398448025

Facility Contacts

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Mustafa H Temel, M.D.

Role: primary

05342714872

Other Identifiers

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SWE1

Identifier Type: -

Identifier Source: org_study_id

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