Enthesis Differences in Rheumatoid Arthritis and Axial Spondyloarthropathy

Rheumatoid Arthritis Clinical Trial

Official title:

Ultrasonographic Differences in Entheses in Rheumatoid Arthritis and Axial Spondyloarthropathy Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05942976
• Other study ID #: 16/09/2022; 2011-KAEK-50;288
• Status: Completed
• Start date: June 16, 2023
• Est. completion date: August 15, 2023

Study information

• Verified date: September 2023
• Source: Istanbul Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: August 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Axial Spondyloarthritis
• Enthesitis
• Enthesopathy
• Rheumatoid Arthritis
• Spondylarthritis
• Spondylarthropathies
• Spondylitis

Intervention

Other:
• ULTRASOUND
10 enthesis areas will be evaluated in 20 minutes with ultrasound.

Locations

Country	Name	City	State
Turkey	Istanbul Training and Resarch Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound enthesis differences between the groups	triceps tendon, quadriceps tendon, proximal patellar tendon, distal patellar tendon and achilles tendons enthesitis scores differences between the groups	2 months
Primary	The relationship between ultrasound findings and disease parameters	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