Spondyloarthritis Inception Cohort of Southern Denmark

NCT06337513 | Enrolling By Invitation

• 1 other identifier: SPINCODE (S-20230055)
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Axial Spondyloarthritis; Back Pain

Outcome Measures

Primary Outcomes (2)

• Clinicians diagnosis of axSpA

  The treating rheumatologists diagnosis of axial spondyloarthritis

  Baseline, week 6, 24, 48, 72 and 96

• Health related quality of life

  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

  Baseline, week 6, week 24, 48, 72 and 96

Secondary Outcomes (24)

• axSpA disease activity

  Baseline, week 24, 48, 72 and 96

• axSpA disease mobility

  Baseline, week 6, 24, 48 and 96

• axSpA patient-reported physical function

  Baseline, week 24, 48, 72 and 96

• Inflammatory back pain (IBP) symptoms

  Baseline, week 6, 12, 24, 48, 72, 96

• Physical examination I

  Baseline, week 6, 24, 48, 72 and 96

Other Outcomes (3)

• Patient global assessment

  Baseline, week 24, 48, 72 and 96

• Acceptable state

  Week 6, 24, 48, 72 and 96

• Mental state

  Week 6, 24, 48, 72 and 96

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention consists of a physiotherapist-coordinated (PT) interdisciplinary outpatient rehabilitation for 6-months.

Other: Rehabilitation intervention

Usual care (control group)

ACTIVE COMPARATOR

Both groups are offered standard care.

Other: Usual care

Interventions

Rehabilitation intervention OTHER

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.

Intervention group

Usual care OTHER

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

Usual care (control group)

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• The Danish Center for Expertise in Rheumatology: lead

Study Sites (1)

Danish Hospital for Rheumatic Diseases

Sønderborg, Southern Denmark, 6400, Denmark

Location

MeSH Terms

Conditions

Axial Spondyloarthritis; Back Pain

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding of the the health care professionals and patients is not possible in the rehabilitation intervention. The person analysing the data will be blinded to the group allocation.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In the rehabilitation feasibility study: pre-post design. In the rehabilitation RCT, participants are allocated to either the intervention or control group with standard care.

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 29, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)