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New study aims to catch spine disease early and test rehab program

NCT ID NCT06337513

Knowledge-focused Sponsor: The Danish Center for Expertise in Rheumatology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study follows 250 people with long-term back pain who may have early axial spondyloarthritis, a type of inflammatory arthritis. Researchers want to learn how the disease develops and whether a 6-month rehab program with a physiotherapist can help. The goal is to reduce the years-long delay in diagnosis and improve quality of life.

What this could mean

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

Active substance
physiotherapist-coordinated rehabilitation program
What this could lead to
If successful, this could lead to earlier diagnosis and better management of axial spondyloarthritis, reducing long-term disability.
What could go wrong
This is an early-stage observational study with a small rehabilitation component, so results may not apply broadly. The intervention is not a drug and may not change disease progression.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 250 people

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

Started

May 2024

Expected to finish

Aug 2028

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.

Ages

18 to 48 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.

Patients with low back pain suspected of axSpA will be included based on the following inclusion and exclusion criteria. Inclusion Criteria: * Age ≥ 18 years * Age at symptom onset ≤ 45 years * Currently diagnosed with undifferentiated lower back pain * Onset of back pain ≥ 3 months ≤ 3 years at referral * Diagnosed with anterior uveitis (AU) and/or psoriasis and/or inflammatory bowel disease (IBD) regardless of human leukocyte antigen B27 (HLA-B27) status * HLA-B 27 positivity (obligatory in case of absence of AU, psoriasis or IBD) * Imaging findings suggestive of axSpA as defined by trained musculoskeletal radiologists, regardless of HLA-B27 status * Patients capable of giving written informed consent Exclusion Criteria: * Age \< 18 years * Age at symptom onset \> 45 years * Recurrent episodes of low back pain for \>3 years * Incapable of complying with the examination program for physical or mental reasons * Not able to provide written consent * Not able to understand Danish * A priori SpA diagnosis * Contradictions to MRI * Treatment with disease modifying antirheumatic drugs (DMARDs) for other conditions * Pregnancy

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Conditions

The condition(s) this trial relates to.

Axial Spondyloarthritis Back Pain spondyloarthropathy

As listed by the trial registrant

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

Axial spondyloarthritis Back pain

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Danish Hospital for Rheumatic Diseases

    Sønderborg, Southern Denmark, 6400, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.