Enthesis Differences in Rheumatoid Arthritis and Axial Spondyloarthropathy

September 3, 2023 updated by: Burak Tayyip Dede, Istanbul Training and Research Hospital

Ultrasonographic Differences in Entheses in Rheumatoid Arthritis and Axial Spondyloarthropathy Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul Training and Resarch Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 months
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
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2023

Primary Completion (Actual)

July 15, 2023

Study Completion (Actual)

August 15, 2023

Study Registration Dates

First Submitted

June 27, 2023

First Submitted That Met QC Criteria

July 11, 2023

First Posted (Actual)

July 12, 2023

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 3, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/09/2022; 2011-KAEK-50;288

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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