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Enthesis Differences in Rheumatoid Arthritis and Axial Spondyloarthropathy

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ClinicalTrials.gov Identifier: NCT05942976
Recruitment Status : Completed
First Posted : July 12, 2023
Last Update Posted : September 6, 2023
Sponsor:
Information provided by (Responsible Party):
Burak Tayyip Dede, Istanbul Training and Research Hospital

Study Description
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Brief Summary:
The aim of this study is to investigate the sonographic differences in entheses in patients with Rheumatoid arthritis and Axial Spondyloarthropathy.

Condition or disease Intervention/treatment
Axial Spondyloarthritis Rheumatoid Arthritis Enthesitis Enthesopathy Other: ULTRASOUND

Detailed Description:
After recording the demographic data of the patients; 5 enthesis regions 5 enthesis sites were evaluated bilaterally as ''tricipital tendon (TT), quadricipital tendon (QT), proximal patellar tendon (PPT), distal patellar tendon (DPT), achilles tendon (AT)'' will be sonographically evaluated and the presence of hypoechogenicity , tendon thickness increase, power Doppler activity, erosion, presence of entezophyte/calcification will be investigated. The differences between the groups will then be compared.
Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 106 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Months
Official Title: Ultrasonographic Differences in Entheses in Rheumatoid Arthritis and Axial Spondyloarthropathy Patients
Actual Study Start Date : June 16, 2023
Actual Primary Completion Date : July 15, 2023
Actual Study Completion Date : August 15, 2023

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Groups and Cohorts
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Group/Cohort Intervention/treatment
group 1: axial spondyloarthritis
SpA patients identified according to the Assessment of Spondyloarthritis classification criteria
 Other: ULTRASOUND
10 enthesis areas will be evaluated in 20 minutes with ultrasound.
group 2: Rheumatoid arthritis
RA patients identified according to the 2010 American College of Rheumatology/Europan Leage Against Rheumatism classification criteria
 Other: ULTRASOUND
10 enthesis areas will be evaluated in 20 minutes with ultrasound.
group:3 Healthy Control
healthy controls with no history of rheumatic diseases
 Other: ULTRASOUND
10 enthesis areas will be evaluated in 20 minutes with ultrasound.


Outcome Measures
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Primary Outcome Measures :
  1. Ultrasound enthesis differences between the groups [ Time Frame: 2 months ]
    triceps tendon, quadriceps tendon, proximal patellar tendon, distal patellar tendon and achilles tendons enthesitis scores differences between the groups

  2. The relationship between ultrasound findings and disease parameters [ Time Frame: 2 months ]
    The relationship between triceps tendon, quadriceps tendon, proximal patellar tendon, distal patellar tendon and achilles tendons enthesitis scores and Clinical disease activity index and BASDAI


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Rheumatoid arthritis patients identified according to the 2010 American College of Rheumatology /Europan Leage Against Rheumatism classification criteria, axial Spondyloarthrtis patients identified according to the Assessment of Spondyloarthritis classification criteria and healthy controls with no history of rheumatic diseases.
Criteria

Inclusion Criteria:

  • Rheumatoid arthritis patients identified according to the 2010 American College of Rheumatology /Europan Leage Against Rheumatism classification criteria,
  • axial Spondyloarthrtis patients identified according to the Assessment of Spondyloarthritis classification criteria
  • healthy controls with no history of rheumatic diseases.

Exclusion Criteria:

  • history of limb trauma and surgery in the last 3 months,
  • metabolic disease (diabetes mellitus, hypothyroidism),
  • malignant neoplasm,
  • limitation of range of motion in the extremity,
  • those who have received corticosteroid injections in the last 3 months,
  • uncontrollable fibromyalgia.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05942976


Locations
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Turkey
Istanbul Training and Resarch Hospital
Istanbul, Turkey
Sponsors and Collaborators
Istanbul Training and Research Hospital
More Information
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Responsible Party: Burak Tayyip Dede, Medical Doctor, Istanbul Training and Research Hospital
ClinicalTrials.gov Identifier: NCT05942976    
Other Study ID Numbers: 16/09/2022; 2011-KAEK-50;288
First Posted: July 12, 2023    Key Record Dates
Last Update Posted: September 6, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Burak Tayyip Dede, Istanbul Training and Research Hospital:
Axial Spondyloarthritis,
Rheumatoid Arthritis
Enthesitis
Ultrasound
Additional relevant MeSH terms:
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Spondylitis
Arthritis
Arthritis, Rheumatoid
Spondylarthritis
Axial Spondyloarthritis
Spondylarthropathies
Enthesopathy
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Infections
Bone Diseases
Spinal Diseases
Ankylosis
Tendinopathy
Muscular Diseases
Tendon Injuries
Wounds and Injuries