Validation of the 2025 ASAS-SPARTAN Criteria for Diagnosing Axial Spondyloarthritis in Chinese Adults with Chronic Back Pain
Led by Chinese PLA General Hospital · Updated on 2026-07-24
247
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the 2025 ASAS-SPARTAN revised classification criteria for axial spondyloarthritis axSpA in Chinese adults with chronic back pain. AxSpA is a chronic inflammatory disease affecting the spine and sacroiliac joints, causing pain and stiffness. This multicenter, prospective, cross-sectional observational study aims to validate the criterias sensitivity, specificity, and scoring accuracy in the Chinese population, addressing racial and environmental differences that may influence diagnosis.
Participants with chronic back pain lasting at least 3 months and back pain onset at age 45 or younger will undergo thorough diagnostic assessments. These include clinical history, physical exams, blood tests CRP, HLA-B27, ESR, pelvic X-rays, sacroiliac joint MRI and CT scans. Diagnosis will be evaluated using the 2025 ASAS-SPARTAN criteria and compared with the 2009 ASAS criteria and clinician diagnoses. No treatments are given as part of the study all care decisions are made by clinicians.
Participants will provide informed consent and complete diagnostic testing during a single assessment. Data collection uses a secure electronic platform ensuring privacy. Researchers will analyze diagnostic accuracy and agreement between criteria using statistical tests. Findings aim to help clinicians choose better diagnostic tools and reduce over-diagnosis, improving care and easing healthcare burdens. The study is scheduled to run for 12 months starting April 2026.
CONDITIONS
Brief Title
Multicenter Validation of the 2025 Classification Criteria for Axial Spondyloarthritis
Research Team
J
Jian Zhu
J
Jian Zhu
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Current chronic back pain lasting 3 months or more
Back pain onset at age 45 or younger
Presenting to a rheumatologist for evaluation of suspected axial spondyloarthritis or related conditions without confirmed diagnosis
Willing to complete full diagnostic assessments including clinical, laboratory, and imaging tests
Voluntary participation with signed informed consent
You will not qualify if you...
Inability to communicate or self-assess due to cognitive or visual impairment
Confirmed diagnosis of axial spondyloarthritis, ankylosing spondylitis, or other rheumatic diseases
Back pain duration less than 3 months or onset after age 45
Medical contraindications preventing completion of diagnostic tests (e.g., metallic implants blocking MRI, severe liver or kidney dysfunction)
Diagnosed non-SpA causes of chronic back pain such as lumbar disc herniation, spinal stenosis, tumors, infections, or fractures
Refusal or inability to provide informed consent or complete study follow-up
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Single assessment during index visit
Participants undergo comprehensive assessments including medical history, physical examination, blood tests, and imaging studies like pelvic X-rays and sacroiliac joint MRI or CT scans.
1 visit (in-person)
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Presence of multiple spondyloarthritis (SpA) features is important but not sufficient for a diagnosis of axial spondyloarthritis: data from the SPondyloArthritis Caught Early (SPACE) cohort.