Ultrasonographic Evaluation of the Shoulder Joint in Patients With Axial Spondyloarthritis

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.

Study Overview

• Status: Completed
• Conditions: Axial Spondyloarthritis
• Intervention / Treatment: Diagnostic test: Shoulder ultrasound

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.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34255
    • Gaziosmanpasa Research and Education Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
BASDAI	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): It consists of six questions about five main symptoms, including fatigue, spinal pain, joint pain or swelling, localised tenderness and morning stiffness.The final BASDAI score ranges from 0 to 10, and higher scores represent higher disease activity.	baseline
BASFI	Bath Ankylosing Spondylitis Functional Index (BASFI): BASFI is an easy-to-administer, sensitive and reliable self-report questionnaire developed to assess physical function in AS patients. It consists of a total of 10 items. The BASFI Score is the average of the 10 items and ranges from 0 to 10, with higher scores indicating more functional limitations.	baseline
BASMI	Bath Ankylosing Spondylitis Metrology Index (BASMI): It is an index consisting of tragus wall, cervical rotations, lumbar lateral flexions, modified Schober and intermalleolar distance measurements.	baseline
VAS	A 100 mm line is drawn, and the two ends of the line are labeled with the two extreme descriptions of pain. The patient is asked to mark their current level of pain on this line. One end of the line is labeled "no pain," and the other end is labeled "severe pain." The patient marks their current condition on the line. The distance from the "no pain" point to where the patient marks on the line represents the intensity of the patient's pain.	baseline

Collaborators and Investigators

• Sponsor: Gaziosmanpasa Research and Education Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2024
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): April 10, 2025

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Actual): December 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 28, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: ultrasonography; shoulder; axial spondyloarthritis
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Infections; Bone Diseases, Infectious; Spinal Diseases; Spondylarthropathies; Ankylosis; Axial Spondyloarthritis; Spondylitis; Spondylarthritis
• Other Study ID Numbers: GaziosmanpasaTREH-FTR-BD-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No