Value of Ultrasonographic Enthesitis Assessment in Spondyloarthritis

Spondyloarthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04946539
• Other study ID #: 83045809-604.01.02
• Status: Completed
• Start date: November 2016
• Est. completion date: March 2017

Study information

• Verified date: June 2021
• Source: Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Enthesitis
• Spondylarthritis
• Spondyloarthritis

Intervention

Diagnostic Test:
• Ultrasonography
Enthesitis assessment via ultrasonography

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease activity,	BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), minimum value 0, maximum value 10, higher scores mean a worse outcome	between November 2016 and January 2017
Primary	Disease activity,	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	between November 2016 and January 2017
Primary	functionality	Bath Ankylosing Spondylitis Functionality Index (BASFI). Minimal values 0, maximum value 100. Higher scores mean a worse outcome	between November 2016 and January 2017
Primary	to measure quality of life	Short Form - 12 (SF-12). minimum value 0 maximum value 100. higher scores mean a worse outcome	between November 2016 and January 2017
Primary	to measure quality of life	Ankylosing Spondylitis Quality of Life (ASQoL). minimum value 0 maximum value 18. Higher scores mean a worse outcome	between November 2016 and January 2017