Enthesis Differences in Rheumatoid Arthritis and Axial Spondyloarthropathy

Sponsor
Istanbul Training and Research Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05942976
Collaborator
(none)
106
1
1.5
70.1

Study Details

Study Description

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 Phase
  • 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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
106 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Ultrasonographic Differences in Entheses in Rheumatoid Arthritis and Axial Spondyloarthropathy Patients
Actual Study Start Date :
Jun 16, 2023
Anticipated Primary Completion Date :
Jul 15, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Ultrasound enthesis differences between the groups [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 [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

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Istanbul Training and Resarch Hospital Istanbul Turkey

Sponsors and Collaborators

  • Istanbul Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Jul 12, 2023
Last Update Posted:
Jul 12, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Burak Tayyip Dede, Medical Doctor, Istanbul Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 12, 2023