Ultrasonographic Evaluation of Asymptomatic Shoulder Joint Pathologies in Rheumatoid Arthritis Patients

NCT06572696 | Recruiting

• 1 other identifier: FSMMD
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rheumatoid Arthritis; Shoulder Injuries and Disorders

Keywords

Rheumatoid arthritis; shoulder; shoulder impingement syndrome

Outcome Measures

Primary Outcomes (1)

• Ultrasound Shoulder Pathology Rating Scale

  Ultrasound Shoulder Pathology Rating Scale point

  20 minute

Secondary Outcomes (1)

• Acromiohumeral Distance

  5 minute

Study Arms (2)

Rheumatoid Arthritis Patients

Tuberculum greater cortical surface irregularity, biceps and supraspinatus tendinopathy, supraspinatus and subscapularis dynamic compression and acromiohumeral distance will be evaluated bilaterally by ultrasound.

Diagnostic Test: Shulder Ultrasound

Healthy individuals

Tuberculum greater cortical surface irregularity, biceps and supraspinatus tendinopathy, supraspinatus and subscapularis dynamic compression and acromiohumeral distance will be evaluated bilaterally by ultrasound.

Diagnostic Test: Shulder Ultrasound

Interventions

Shulder Ultrasound DIAGNOSTIC_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.

Healthy individuals; Rheumatoid Arthritis Patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Istanbul Physıcal Therapy And Rehabılıtatıon Traınıng And Research Hospıtal

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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.

  PMID: 20215140 BACKGROUND

• 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.

  PMID: 17417983 BACKGROUND

• 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.

  PMID: 19473557 BACKGROUND

• 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.

  PMID: 31670481 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid; Shoulder Injuries; Disease; Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yunus Emre Dogan, MD

  Istanbul Fatih Sultan Mehmet Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Muhsin Doran, MD

  Istanbul Liv Hospital

  STUDY CHAIR

• Cigdem Cinar, Assoc Prof

  Istanbul Biruni University

  STUDY CHAIR

• Burak Kutuk, MD

  Hatay Defne State Hospital

  STUDY CHAIR

Central Study Contacts

Yunus Emre Dogan, MD

CONTACT

05060512500; ynsemredgn91@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 27, 2024
• Study Start: August 12, 2024
• Primary Completion: September 2, 2024
• Study Completion: September 2, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)