Value of Ultrasonographic Enthesitis Assessment in Spondyloarthritis
June 29, 2021 updated by: Gunay ER, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
The aim of the study is to determine how valuable ultrasonographic enthesitis to asssess disease activity, functionality and quality of life.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
97
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
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Spondyloarthritis
Description
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
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
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Spondyloarthritis
|
Enthesitis assessment via ultrasonography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disease activity,
Time Frame: 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
|
between November 2016 and January 2017
|
|
Disease activity,
Time Frame: 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
|
between November 2016 and January 2017
|
|
functionality
Time Frame: between November 2016 and January 2017
|
Bath Ankylosing Spondylitis Functionality Index (BASFI).
Minimal values 0, maximum value 100.
Higher scores mean a worse outcome
|
between November 2016 and January 2017
|
|
to measure quality of life
Time Frame: between November 2016 and January 2017
|
Short Form - 12 (SF-12).
minimum value 0 maximum value 100.
higher scores mean a worse outcome
|
between November 2016 and January 2017
|
|
to measure quality of life
Time Frame: between November 2016 and January 2017
|
Ankylosing Spondylitis Quality of Life (ASQoL).
minimum value 0 maximum value 18.
Higher scores mean a worse outcome
|
between November 2016 and January 2017
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
November 1, 2016
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
June 22, 2021
First Submitted That Met QC Criteria
June 29, 2021
First Posted (Actual)
July 1, 2021
Study Record Updates
Last Update Posted (Actual)
July 1, 2021
Last Update Submitted That Met QC Criteria
June 29, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 83045809-604.01.02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.