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OpenTrials
Completed

NCT Number: NCT04946539

Value of Ultrasonographic Enthesitis Assessment in Spondyloarthritis

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

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Key information

Conditions

Spondyloarthritis Arthritis Bone Diseases Enthesitis Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylitis

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultrasonography

Diagnostic Test

Enthesitis assessment via ultrasonography

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 1, 2021
Registry last updated
Jul 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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