Reliability of IBP Criteria & Activity Scores in Patients With AxSpA (IBP/AxSpA)

January 24, 2023 updated by: Noha Ehab Hamed, Zagazig University

Reliability of Inflammatory Back Pain Criteria and Activity Scores in Patients With Axial Spondyloarthritis

The current ASAS classification of AxSpA relies either on sacroiliitis on imaging plus one SpA feature (imaging arm) or HLA-B27 antigen plus two SpA features (clinical arm), in a patient with chronic back pain and age at onset of less than 45 years. IBP which is a major symptom of SpA depends more on patient's perception which is not usually accurate. As well, disease activity is measured by ASDAS, BASDAI, and BASFAI which depend more on subjective measures. Assessment of reliability of IBP criteria, ASDAS, BASDAI, and BASFAI in diagnosis and evaluation of activity of AxSpA is essential for better health care.

Study Overview

Status

Completed

Conditions

Detailed Description

Axial spondyloarthritis (AxSpA) is a chronic inflammatory disease that affects the axial skeleton mainly leading to significant pain and disability. Early diagnosis of AxSpA is important for better management of symptoms and to limit spinal damage. The last classification of AxSpA is ASAS classification criteria which relies either on sacroiliitis on imaging plus one SpA feature (imaging arm) or HLA-B27 antigen plus two SpA features (clinical arm), in a patient with chronic back pain and age at onset of less than 45 years. Inflammatory back pain (IBP) is the key clinical symptom of AxSpA and is often present at disease onset. There are different sets of IBP criteria which include the Calin criteria , Berlin criteria, and the Assessment of SpondyloArthritis international Society (ASAS) IBP experts criteria. These sets when assessed by different rheumatologists had different sensitivity and specificity.

As IBP has certain characters, taking the clinical history has been considered as a screening test for patients with chronic back pain to identify patients with AxSpA. But, the value of this screening test has been questioned. Disease activity in AxSpA has been measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). It has been used extensively since 1994 but with some limitations as it does not include the physician's assessment of the disease and does not assess the impact of specific clinical factors.

The Bath Ankylosing Spondylitis Functional Index (BASFI) has been also developed as an approach to defining and monitoring functional ability in patients with AxSpA. ASAS developed a disease activity score for patient with AxSpA which is called Ankylosing Spondylitis Disease Activity Score (ASDAS) that combines patient-reported assessments with acute phase reactants (C-reactive protein [CRP] or erythrocyte sedimentation rate [ESR]). However, it is based largely on subjective measures, and lacks objective biomarker of disease activity.

The evaluation of disease activity in AxSpA is complex and multifactorial. Also, patients and physicians have different perspectives of the disease and none of the current single-item or combined indexes adequately unifies both perspectives.

Study Type

Observational

Enrollment (Actual)

206

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Sharqia
      • Zagazig, Sharqia, Egypt
        • Zagazig University

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Group 1 Patients diagnosed as AxSpA according to the ASAS classification criteria for AxSpA. Group 2 Patients diagnosed as chronic (more than 3 months) mechanical back pain, the diagnosis has been made prior to the study by the treating specialist, these patients are herein as a control group.

Description

Inclusion Criteria:

  • Group 1
  • Patients diagnosed as AxSpA.
  • Age > 18 years and < 45 years at onset of the disease. Group 2
  • Patients diagnosed as chronic mechanical back pain.
  • Age > 18 years and < 45 years at onset of the disease.

Exclusion Criteria:

  • Patients having acute or subacute back pain.
  • Patients having back pain referred from another site.
  • Patients with any other autoimmune disease: rheumatoid arthritis, systemic lupus erythematosus, Behçet's disease… etc.

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
patients with axial spondyloarthritis
ASAS classification criteria which relies either on sacroiliitis on imaging plus one SpA feature (imaging arm) or HLA-B27 antigen plus two SpA features (clinical arm), in a patient with chronic back pain and age at onset of less than 45 years
patients with mechanical back pain
Patients diagnosed as chronic (more than 3 months) mechanical back pain, the diagnosis has been made prior to the study by the treating specialist, these patients are herein as a control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of reliability, sensitivity, and specificity of inflammatory back pain criteria (the Assessment of SpondyloArthritis international Society IBP experts criteria) depending on a gold standard which is the global evaluation of the rheumatologist.
Time Frame: 8/2021 to 5/2022

Assessment of reliability of each item and the whole set of inflammatory back pain criteria ( the Assessment of SpondyloArthritis international Society (ASAS) IBP experts criteria) depending on a gold standard which is the global evaluation of expert rheumatologist: is it inflammatory or mechanical back pain.

The Assessment of SpondyloArthritis international Society (ASAS) IBP experts criteria includes 5 items: age at onset ≤ 40 years, insidious onset, improvement with exercise, no improvement with rest, pain at night. This set of criteria is achieved if at least four parameters are met.
8/2021 to 5/2022
assessment of reliability of Ankylosing Spondylitis Disease Activity Score in axial spondyloarthritis patients.
Time Frame: 8/2021 to 5/2022

Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) includes 4 questions about disease activity (Axial pain, Peripheral Pain/Swelling, Duration of Morning Stiffness, activity of the disease on average during the last week) and CRP. Each question has a score from 0 to 10. 0 means no, and 10 means sever.

ASDAS_CRP = 0.121 × total back pain + 0.110 × patient global + 0.073 × peripheral pain / swelling + 0.058 × duration of morning stiffness + 0.579 × Ln (CRP+1).

ASDAS scores : <1.3 "inactive disease" and <2.1"low disease activity", ≤3.5 "high disease activity", and >3.5 "very high disease activity".

The score is applied to the same group of patients by 2 rheumatologists. The scores of each question and the total score that detected by the two rheumatologists are compared to detect agreement between the two rheumatologist and assess reliability of this score
8/2021 to 5/2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Study Director: Eman El-shahawy, Zagazig University
  • Study Director: Mohamed Mortada, Zagazig University
  • Study Director: Safaa Elnaggar, Zagazig University
  • Principal Investigator: Noha Hamed, Zagazig University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 20, 2021

Primary Completion (Actual)

February 22, 2022

Study Completion (Actual)

May 25, 2022

Study Registration Dates

First Submitted

December 22, 2021

First Submitted That Met QC Criteria

April 6, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Actual)

January 25, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZU-IRB #6983/13-6-2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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