Value of Ultrasonographic Enthesitis Assessment in Spondyloarthritis

• Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization (Other)
• Overall Status: Completed
• CT.gov ID: NCT04946539
• Collaborator: (none)
• Enrollment: 97
• Actual Duration (Months): 3.9

Study Details

Study Description

Brief Summary

The aim of the study is to determine how valuable ultrasonographic enthesitis to asssess disease activity, functionality and quality of life.

Condition or Disease	Intervention/Treatment	Phase
Spondyloarthritis; Enthesitis	Diagnostic Test: Ultrasonography

Study Design

• Study Type: Observational
• Actual Enrollment: 97 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Actual Study Start Date: Nov 1, 2016
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Spondyloarthritis	Diagnostic Test: Ultrasonography; Enthesitis assessment via ultrasonography

Outcome Measures

Primary Outcome Measures

1. Disease activity, [between November 2016 and January 2017]

   BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), minimum value 0, maximum value 10, higher scores mean a worse outcome

2. Disease activity, [between November 2016 and January 2017]

   Ankylosing Spondylitis Disease Activity Score (ASDAS). It is calculated by adding CRP (ASDAS-CRP) or ESR (ASDAS-ESR). there is no spesific minimal and maximum value because it depends on CRP or ESR value. Higher scores mean a worse outcome

3. functionality [between November 2016 and January 2017]

   Bath Ankylosing Spondylitis Functionality Index (BASFI). Minimal values 0, maximum value 100. Higher scores mean a worse outcome

4. to measure quality of life [between November 2016 and January 2017]

   Short Form - 12 (SF-12). minimum value 0 maximum value 100. higher scores mean a worse outcome

5. to measure quality of life [between November 2016 and January 2017]

   Ankylosing Spondylitis Quality of Life (ASQoL). minimum value 0 maximum value 18. Higher scores mean a worse outcome

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• Spondyloarthritis patients that fulfill 2009 ASAS criteria

Exclusion Criteria:

• history of elbow, ankle or knee surgery, local injection at the examination sites within the six weeks, peripheral neuropathy, infection and wound at examination site

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gunay ER, Medical Doctor, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
• ClinicalTrials.gov Identifier: NCT04946539
• Other Study ID Numbers: 83045809-604.01.02
• First Posted: Jul 1, 2021
• Last Update Posted: Jul 1, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Spondylitis; Spondylarthritis

Study Results

No Results Posted as of Jul 1, 2021