Spondyloarthritis Inception Cohort of Southern Denmark

NCT06337513 · tracked via the Priya Life Science Denmark tracker

Sponsor

The Danish Center for Expertise in Rheumatology

Phase

Not applicable

Started

2024-05-01

Last updated

2025-09-22

Condition(s) studied

Axial SpondyloarthritisBack Pain

Investigational drug(s) / intervention(s)

Rehabilitation interventionUsual care

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.

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

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

48 Years

Healthy volunteers

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

Primary outcome measure(s)

Clinicians diagnosis of axSpA — Baseline, week 6, 24, 48, 72 and 96
The treating rheumatologists diagnosis of axial spondyloarthritis
Health related quality of life — Baseline, week 6, week 24, 48, 72 and 96
EuroQol -5-dimension 5 level-version (EQ-5D-5L) is a generic measure to assess population health. Includes five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The EQ-5D-5L index ranges from 0.00 to 1.00. The highest score, the better health related quality of life

Trial sites (1)

Facility	City	Region	Status
Danish Hospital for Rheumatic Diseases	Sønderborg	Southern Denmark

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06337513 on ClinicalTrials.gov ↗ ← All trials in Denmark