Ultrasonographic Evaluation of the Shoulder Joint in Patients With Axial Spondyloarthritis

NCT06727266 | Completed

• 1 other identifier: GaziosmanpasaTREH-FTR-BD-001
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Axial Spondyloarthritis

Keywords

axial spondyloarthritis; ultrasonography; shoulder

Outcome Measures

Primary Outcomes (1)

• Shoulder ultrasound findings

  Pathologies detected in the shoulder joint will be evaluated; tendon damage, bursitis, joint effusion, enthesitis etc. Enthesitis: Abnormal hypoechoic structure (loss of fibrillar structure of the tendon), thickening at the site of attachment of the tendon or ligament to the bone with associated Doppler signal and bone irregularities (calcification, cortical irregularity, enthesophyte). Synovitis: An abnormal hypoechoic intra-articular structure that is less compressed and may give a Doppler signal. Bursitis: Normally the bursa contains a thin layer of fluid, but in bursitis the amount of fluid increases and the bursa enlarges. There may be a marked thickening of the bursa walls. In bursitis, especially if it is chronic, septations (membrane formations) may be seen within the bursa. Effusion: Increased fluid in the joint space, manifested as anechoic fluid. Erosion: Causes irregularity or disruption of the normally flat bone cortex.

  baseline

Secondary Outcomes (4)

• BASDAI

  baseline

• BASFI

  baseline

• BASMI

  baseline

• VAS

  baseline

Study Arms (2)

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.

Diagnostic Test: Shoulder ultrasound

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.

Diagnostic Test: Shoulder ultrasound

Interventions

Shoulder ultrasound 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.

Axial Spondyloarthritis Patients; Healthy individuals

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Axial SpA patients and healthy volunteers (have close demographic data with Axial SpA patients)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpaşa Research and Education Hospital

Istanbul, 34255, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 10, 2024
• Study Start: December 4, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 10, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

TU (1)