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Can new criteria better spot a spine disease that mimics back pain?

NCT ID NCT07724847

Knowledge-focused Sponsor: Chinese PLA General Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This study aims to validate the 2025 ASAS-SPARTAN classification criteria for axial spondyloarthritis (axSpA) in Chinese patients with chronic back pain. AxSpA is a chronic inflammatory spine disease often misdiagnosed. Researchers will compare the new criteria against standard clinical diagnosis to see if they improve accuracy and reduce over-diagnosis in this population.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If the new criteria prove accurate, they could help doctors diagnose axial spondyloarthritis earlier and reduce over-diagnosis in Chinese patients.
What could go wrong
This is an observational validation study, not a treatment trial. The criteria may not perform as well in this population as hoped, and results may not apply to other groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 247 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults with chronic back pain (duration ≥3 months, onset age ≤45 years) who are suspected of having axial spondyloarthritis and present to rheumatology clinics for diagnostic evaluation. Participants must be willing to undergo comprehensive clinical, laboratory, and imaging assessments.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1\. Presence of current chronic back pain with duration ≥3 months and without a definitive diagnosis 2. Age at onset of back pain ≤45 years 3. Presentation to a rheumatologist for evaluation of suspected axial spondyloarthritis or related conditions, without a confirmed diagnosis of axSpA or other rheumatic diseases 4. Willingness to complete comprehensive diagnostic assessments including clinical history, physical examination, CRP testing, HLA-B27 testing, pelvic X-ray, and sacroiliac joint MRI (recent imaging may be acceptable if completed within appropriate timeframe) 5. Voluntary participation with provision of signed electronic informed consent Exclusion Criteria: * 1\. Inability to communicate due to cognitive impairment, visual impairment, or other factors affecting self-assessment 2. Confirmed diagnosis of axial spondyloarthritis (axSpA), ankylosing spondylitis (AS), or other established rheumatic diseases (e.g., rheumatoid arthritis, psoriatic arthritis) 3. Back pain duration \<3 months or age at onset \>45 years 4. Refusal or inability to complete full diagnostic evaluation due to medical contraindications (e.g., metallic implants preventing MRI, severe hepatic or renal dysfunction precluding laboratory testing) 5. Presence of clearly identified non-SpA causes of chronic back pain with established diagnosis, including lumbar disc herniation, spinal stenosis, spinal tumors, infectious spondylitis, or osteoporotic fractures 6. Failure to provide informed consent, inability to cooperate with study follow-up, or inability to provide complete data

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Conditions

The condition(s) this trial relates to.

Axial Spondyloarthritis Spondylarthritis spondyloarthropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Axial spondyloarthritis (axspa) Chronic back pain Spondyloarthritis (SPA)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chinese PLA General Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100853, China

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