Ultrasonographic Evaluation of the Shoulder Joint in Patients With Axial Spondyloarthritis

NCT ID: NCT06727266

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-04
• Study Completion Date: 2025-04-10

Brief Summary

The aim of this observational study is to assess shoulder joint involvement in patients with axial spondyloarthritis using ultrasound and to compare the findings with those of healthy controls.

Detailed Description

Axial spondyloarthritis (axial SpA) is a chronic inflammatory rheumatic disease that causes inflammation of the spine and sacroiliac joints. The condition usually begins at a young age (between 20 and 40 years). Common complaints include back pain, morning stiffness, and gradual restriction of spinal movement. Complaints of peripheral joint involvement may also be observed.

Shoulder involvement in patients with axial spondyloarthritis (axial SpA) represents a manifestation of the disease that can affect peripheral joints. Shoulder involvement typically develops as a result of an inflammatory process and is manifested by symptoms such as pain, swelling, and limitation of movement. The glenohumeral joint, acromioclavicular joint, subacromial bursa, and rotator cuff tendons are most commonly affected. Such peripheral joint involvement may indicate a more severe progression of axial SpA and an increased future disease burden.

Ultrasound is an inexpensive, non-invasive, and radiation-free imaging modality that is widely used in the assessment of the musculoskeletal system. In inflammatory rheumatic diseases such as axial SpA, ultrasound is a highly effective method for the early detection of inflammation. Inflammatory findings such as synovitis, tenosynovitis, enthesitis, and bursitis can be identified by ultrasound in the early stages of the disease. Early detection of these findings can slow disease progression and prevent joint damage by facilitating timely initiation of treatment.

The objective of this observational study is to evaluate the shoulder joint using ultrasound in patients with axial spondyloarthritis and to compare the findings with healthy controls.

The case group will consist of patients aged 18 to 65 who have been diagnosed with axial spondyloarthritis by a specialist in physical medicine and rehabilitation and who are being followed up at the PMR Outpatient Clinics of the Department of Physical Medicine and Rehabilitation, University of Health Sciences Gaziosmanpaşa Training and Research Hospital.

The control group will consist of individuals meeting the inclusion criteria, matched to the case group in terms of age and gender, and admitted to the PMR Outpatient Clinics of the Department of Physical Medicine and Rehabilitation, University of Health Sciences Gaziosmanpaşa Training and Research Hospital for any reason.

Physical examinations and ultrasound scans of the shoulder joint will be performed on all participants.

At the end of the study, data from both groups will be compared.

Conditions

Axial Spondyloarthritis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Axial Spondyloarthritis Patients

Demographic information such as age, height, weight and body mass index (BMI) will be recorded. During the physical examination, shoulder range of motion is measured and recorded. Shoulder pain will be assessed using the Visual Analogue Scale (VAS) and the Shoulder Pain and Disability Index (SPADI). Disease activity will be assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Functional status will be assessed using the Bath Ankylosing Spondylitis Functional Index (BASFI). Spinal mobility will be assessed using the Bath Ankylosing Spondylitis Metrology Index (BASMI). Shoulder imaging will be performed using a Mindray DC-8 ultrasound device in accordance with European Society of Musculoskeletal Radiology (ESSR) protocols.

Shoulder ultrasound

Intervention Type: DIAGNOSTIC_TEST

The ultrasound examination is performed according to the protocols of the European Society of Musculoskeletal Radiology (ESSR). The tendons of the muscles forming the rotator cuff, the enthesis regions, the tendon of the long head of the biceps muscle, the subacromial-subdeltoid bursa, the acromioclavicular and glenohumeral joints are examined.

Healthy individuals

Demographic information such as age, height, weight and body mass index (BMI) will be recorded. During the physical examination, shoulder range of motion is measured and recorded. Shoulder pain will be assessed using VAS (Visual Analogue Scale) and SPADI (Shoulder Pain and Disability Index). Imaging of the shoulder joints will be performed using a Mindray DC-8 ultrasound machine according to European Society of Musculoskeletal Radiology (ESSR) protocols.

Shoulder ultrasound

Intervention Type: DIAGNOSTIC_TEST

The ultrasound examination is performed according to the protocols of the European Society of Musculoskeletal Radiology (ESSR). The tendons of the muscles forming the rotator cuff, the enthesis regions, the tendon of the long head of the biceps muscle, the subacromial-subdeltoid bursa, the acromioclavicular and glenohumeral joints are examined.

Interventions

Shoulder ultrasound

The ultrasound examination is performed according to the protocols of the European Society of Musculoskeletal Radiology (ESSR). The tendons of the muscles forming the rotator cuff, the enthesis regions, the tendon of the long head of the biceps muscle, the subacromial-subdeltoid bursa, the acromioclavicular and glenohumeral joints are examined.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients with a radiographic or non-radiographic diagnosis of axial spondyloarthritis according to ASAS 2009 classification criteria
• Patients aged 18-65
• For healthy controls; people aged 18-65 years who attended PMR outpatient clinics for any reason, without a diagnosis of inflammatory disease and without complaints of shoulder pain.

Exclusion Criteria

• People under 18 and over 65
• History of shoulder trauma
• History of upper extremity surgery
• History of fracture of the upper extremity
• History of malignancy
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gaziosmanpasa Research and Education Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Berke Demir

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gaziosmanpaşa Research and Education Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

GaziosmanpasaTREH-FTR-BD-001

Identifier Type: -

Identifier Source: org_study_id