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Spondyloarthritis Inception Cohort of Southern Denmark

NCT06337513 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-09-22

No results posted yet for this study

Summary

People with axial spondyloarthritis (axSpA) experience a diagnostic delay of 6.5 years in men and up to 8.8 years in women. One of the reasons for the diagnostic delay seems to be limited awareness of the disease characteristics in the referring health care professionals in primary care. By raising awareness about the disease, the study aims at reducing the diagnostic delay and improving early treatment. In addition to diagnostic and pharmacological treatment, physical exercise and rehabilitation are recommended in people with axSpA. In Denmark, people with axSpA are only offered free of charge physiotherapy when the disease has progressed to a stage with radiographic changes of the spine even though people in the early stage of axSpA report a similar disease burden.

The overall objective of Spondyloarthritis Inception Cohort of Southern Denmark (SPINCODE) is to set up an axSpA inception cohort among individuals with low back pain ≥ 3 months who are considered to be at risk for axSpA. The investigators aim to learn more about the course of axSpA during the early stage of disease appropriately assess outcomes, including novel imaging techniques and identify predictive outcomes. Moreover, the investigators want to test the effect of an outpatient physiotherapist-coordinated rehabilitation intervention in people suspected of having axSpA.

Conditions

Interventions

OTHER

Rehabilitation intervention

The intervention consists of a physiotherapist-coordinated (PT) interdisciplinary outpatient rehabilitation offer for 6-months. The intervention encompasses 3 individual sessions with the PT, if needed individual sessions with the interdisciplinary team (PT, occupational therapist, OT, nurse, and social worker) (a maximum of 6 hours), and patient education in two group seminars.

OTHER

Usual care

Both the intervention and the control group will receive usual care.

Sponsors & Collaborators

  • The Danish Center for Expertise in Rheumatology

    lead OTHER

Principal Investigators

  • Georg Kroeber, MD · Danish Centre for Expertise in Rheumatology at the Danish Hospital for Rheumatic Diseases, Department of Regional Health Research (IRS), University of Southern Denmark (SDU)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
48 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2028-08-31
Completion
2028-08-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06337513 on ClinicalTrials.gov