Axial SpondyloarthritisNCT06727266
Ultrasonographic Evaluation of the Shoulder Joint in Patients With Axial Spondyloarthritis
An observational study of Axial Spondyloarthritis, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- Shoulder ultrasound
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Dec 2024to 10 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Axial SpA patients and healthy volunteers (have close demographic data with Axial SpA patients)
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpaşa Research and Education Hospital
Istanbul, 34255
About this study
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.
Read the 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
- Being tested
- Shoulder ultrasound
- Keywords
- axial spondyloarthritis, ultrasonography, shoulder
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder ultrasoundDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Shoulder ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start4 Dec 2024
- Primary completion1 Apr 2025
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Berke Demir, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727266
- Sponsor's protocol ID
- GaziosmanpasaTREH-FTR-BD-001
- Status last verified
- Jun 2025
- First submitted
- 4 Dec 2024
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Evaluation of the Shoulder Joint in Patients With Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT06727266
- Acronym / sponsor ID
- GaziosmanpasaTREH-FTR-BD-001
- Conditions
- Axial Spondyloarthritis
- Keywords
- axial spondyloarthritis, ultrasonography, shoulder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Axial Spondyloarthritis Patients | – | Diagnostic Test: Shoulder ultrasoundDemographic 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. |
| Healthy individuals | – | Diagnostic Test: Shoulder ultrasoundDemographic 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Axial SpA patients and healthy volunteers (have close demographic data with Axial SpA patients)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shoulder ultrasoundThe 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. | Diagnostic test | Axial Spondyloarthritis Patients, Healthy individuals |
Primary outcome
Shoulder ultrasound findings
Time frame: baseline
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.
4 secondary outcomes
BASDAI
Time frame: baseline
BASFI
Time frame: baseline
BASMI
Time frame: baseline
VAS
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
Related trials for Axial Spondyloarthritis
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Identification of Serum Level of Glutathione Peroxidase 4
Spondyloarthropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Axial Spondyloarthritis, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder ultrasound findings (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.