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AzTrials

Rheumatoid ArthritisUEASJPRAPNCT06572696

Ultrasonographic Evaluation of Asymptomatic Shoulder Joint Pathologies in Rheumatoid Arthritis Patients

An observational study of Rheumatoid Arthritis and Shoulder Injuries and Disorders, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Ultrasonographic determination of changes and degree of damage in asymptomatic shoulder joint periarticular structures in RA patients and comparison with healthy controls. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
What is being tested?
Shulder Ultrasound
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
12 Aug 2024to 2 Sep 2024
How long will I take part?
1 Day
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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: RA patients and healthy volunteers(have close demographic data with RA patients)

Who may be able to join

  • RA patients between the ages of 18-75 who has been diagnosed with RA for at least 12 months according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria and has no complaint of shoulder pain.

Who cannot join

  • Patients with clinically suspected shoulder pathology, a history of previous shoulder surgery, a history of direct trauma to the shoulder, a history of infectious arthritis, other connective tissue diseases, serious and chronic somatic or psychiatric diseases, any fracture in the upper extremities, and patients with limited joint movement.

Trial locations and contacts

1 site in 1 country.

Yunus Emre Dogan, MD contact

05060512500

ynsemredgn91@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Istanbul Physıcal Therapy And Rehabılıtatıon Traınıng And Research Hospıtal

    Istanbul

    Kadriye Ones, Prof, 0532 243 28 70, kadriyeones@yahoo.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Ultrasonographic Evaluation of Asymptomatic Shoulder Joint Pathologies in Rheumatoid Arthritis Patients Compared to Healthy Controls: Case-Controlled Study

Ultrasonographic determination of changes and degree of damage in asymptomatic shoulder joint periarticular structures in RA patients and comparison with healthy controls.

Read the detailed description

It was designed as a prospective single-blind case-controlled clinical study. Written informed consent was obtained from all study participants who met the study criteria and agreed to participate in the study.

30 RA patients between the ages of 18-75 who had been diagnosed with RA for at least 12 months according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria and had no complaint of shoulder pain; Patients will be randomly assigned to the patient group according to the order in which they arrive at the outpatient clinic, regardless of age, gender and disease activation. Exclusion criteria for the study include patients with clinically suspected shoulder pathology, a history of previous shoulder surgery, a history of direct trauma to the shoulder, a history of infectious arthritis, other connective tissue diseases, serious and chronic somatic or psychiatric diseases, any previous fracture in the upper extremities, and patients with limited joint movement.

Healthy volunteers who do not have any complaints or problems regarding the shoulder area will be included in the control group, consisting of a total of 30 participants with similar age, gender and non-RA comorbidities as the RA patient group. Exclusion criteria are the same as the exclusion criteria for the RA patient group.

Demographic data of RA and healthy volunteers such as age, height, weight, body mass index (BMI), gender, marital status, education level, occupation and dominant hand will be recorded. Joint examinations will be performed by an experienced rheumatologist to evaluate the patients' sensitive and swollen joints. The medical history of the patients with RA, including the duration of the disease and the medications they use, and the shoulder joint examination of all participants will be performed by the same physical medicine and rehabilitation specialist doctor blinded to the patient and healthy volunteers. During the examination, joint range of motion (ROM) which include active and passive flexion, extension, abduction, internal and external rotation movements of the shoulder and special tests (Hawkins, Neer, Jobe, Patte, Yergason, Gerber) will be used.

US evaluation of both shoulders of all participants will be performed by the same experienced doctor with more than 5 years of experience in this field, using the MyLab60 brand US machine with a 7-12 MHz superficial probe. The physician performing the evaluation will be blinded to the participants. In order to evaluate intra-rater reliability, measurements will be made twice on 5 patients, 1 day apart.

Ultrasound Shoulder Pathology Rating Scale (USPRS) will be used in the evaluation. USPRS consists of 3 static and 2 dynamic examinations. Static tests; It consists of evaluation of greater tuberculum cortical surface irregularity, biceps and supraspinatus tendinopathy. Dynamic tests are performed to evaluate supraspinatus and subscapularis compression by having the patient abduct and externally rotate, respectively. The USPRS score varies between 0-20 points, while 0 points indicate no pathology, 20 points indicate the highest level of pathology in all variables. While the participants are in a sitting position; A total of 5 variables, including bicipital tendinopathy, supraspinatus tendinopathy, greater tuberculum cortical surface irregularity, supraspinatus dynamic and subscapularis dynamic examination, are evaluated and scored according to the level of pathology; The total USPRS score is obtained by adding the scores of all variables.

Another parameter evaluated by ultrasonography in this study is the acromiohumeral distance (AHM) measurement. One of the most common causes of shoulder pain is subacromial impingement syndrome, and AHM measurement with musculoskeletal ultrasound (MSK-US) is important as it is also a two-dimensional linear measurement of the subacromial area and a marker of rotator cuff diseases. In AH distance measurement with MSK-US, two measurements will be made with all participants in a neutral resting position and their hands at the top of the circle with the elbow angle of 110 °. In both positions, the probe will be placed longitudinally at the lateral point of the acromion determined by palpation, the distance determined between the acromion and the humeral head will be displayed and measured.

Being tested
Shulder Ultrasound
Keywords
Rheumatoid arthritis, shoulder, shoulder impingement syndrome
Medical subject headings
Arthritis, Rheumatoid, Shoulder Injuries, Disease, Shoulder Impingement Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shulder UltrasoundDiagnostic test

    Ultrasound Shoulder Pathology Rating Scale (USPRS) will be used in the evaluation. While the participants are in a sitting position; A total of 5 variables, including bicipital tendinopathy, supraspinatus tendinopathy, greater tuberculum cortical surface irregularity, supraspinatus dynamic and subscapularis dynamic examination, are evaluated and scored according to the level of pathology; The total USPRS score is obtained by adding the scores of all variables.

    Another parameter evaluated by ultrasonography in this study is the acromiohumeral distance measurement. In AH distance measurement with MSK-US, two measurements will be made with all participants in a neutral resting position and their hands at the top of the circle with the elbow angle of 110 °. In both positions, the probe will be placed longitudinally at the lateral point of the acromion determined by palpation, the distance determined between the acromion and the humeral head will be displayed and measured.

Study groups in NCT06572696
Study groupRoleWhat they receive
Rheumatoid Arthritis PatientsTuberculum greater cortical surface irregularity, biceps and supraspinatus tendinopathy, supraspinatus and subscapularis dynamic compression and acromiohumeral distance will be evaluated bilaterally by ultrasound.
Receives: Diagnostic Test: Shulder Ultrasound
Healthy individualsTuberculum greater cortical surface irregularity, biceps and supraspinatus tendinopathy, supraspinatus and subscapularis dynamic compression and acromiohumeral distance will be evaluated bilaterally by ultrasound.
Receives: Diagnostic Test: Shulder Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ultrasound Shoulder Pathology Rating Scale

    Ultrasound Shoulder Pathology Rating Scale point

    Measured: 20 minute

Secondary outcomes (1)
  1. Acromiohumeral Distance

    Acromiohumeral Distance millimetric measurement

    Measured: 5 minute

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2024
  2. Study start12 Aug 2024
  3. Primary completion2 Sep 2024 (estimated)
  4. Study completion2 Sep 2024 (estimated)

Resources

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
60 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT06572696
Sponsor's protocol ID
FSMMD
Acronym
UEASJPRAP
Status last verified
Aug 2024
First submitted
23 Aug 2024
Last updated
27 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Smolen JS, Aletaha D, Bijlsma JW, Breedveld FC, Boumpas D, Burmester G, Combe B, Cutolo M, de Wit M, Dougados M, Emery P, Gibofsky A, Gomez-Reino JJ, Haraoui B, Kalden J, Keystone EC, Kvien TK, McInnes I, Martin-Mola E, Montecucco C, Schoels M, van der Heijde D; T2T Expert Committee. Treating rheumatoid arthritis to target: recommendations of an international task force. Ann Rheum Dis. 2010 Apr;69(4):631-7. doi: 10.1136/ard.2009.123919. Epub 2010 Mar 9.

    PubMed 20215140
  • Filippucci E, Iagnocco A, Meenagh G, Riente L, Delle Sedie A, Bombardieri S, Valesini G, Grassi W. Ultrasound imaging for the rheumatologist VII. Ultrasound imaging in rheumatoid arthritis. Clin Exp Rheumatol. 2007 Jan-Feb;25(1):5-10.

    PubMed 17417983
  • Filippucci E, Meenagh G, Delle Sedie A, Salaffi F, Riente L, Iagnocco A, Scire CA, Montecucco C, Bombardieri S, Valesini G, Grassi W. Ultrasound imaging for the rheumatologist. XX. Sonographic assessment of hand and wrist joint involvement in rheumatoid arthritis: comparison between two- and three-dimensional ultrasonography. Clin Exp Rheumatol. 2009 Mar-Apr;27(2):197-200.

    PubMed 19473557
  • Abdelzaher MG, Tharwat S, AbdElkhalek A, Abdelsalam A. Ultrasound versus magnetic resonance imaging in the evaluation of shoulder joint pathologies in a cohort of rheumatoid arthritis patients. Int J Rheum Dis. 2019 Dec;22(12):2158-2164. doi: 10.1111/1756-185X.13728. Epub 2019 Oct 31.

    PubMed 31670481

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis and Shoulder Injuries and Disorders, run by Fatih Sultan Mehmet Training and Research 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Aug 2024. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yunus Emre Dogan, MD (05060512500, ynsemredgn91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ultrasound Shoulder Pathology Rating Scale (time frame: 20 minute). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06572696, which also lists 4 linked publications.

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 27 Aug 2024.

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