protocolSection identificationModule nctId: NCT06337513, orgStudyIdInfo id: S-20230055, briefTitle: Spondyloarthritis Inception Cohort of Southern Denmark, acronym: SPINCODE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-08, completionDateStruct date: 2028-08, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: The Danish Center for Expertise in Rheumatology, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Axial Spondyloarthritis, conditions: Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: 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., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: 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., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Rehabilitation intervention, interventions name: Usual care, outcomesModule primaryOutcomes measure: Clinicians diagnosis of axSpA, primaryOutcomes measure: Health related quality of life, secondaryOutcomes measure: axSpA disease activity, secondaryOutcomes measure: axSpA disease mobility, secondaryOutcomes measure: axSpA patient-reported physical function, secondaryOutcomes measure: Inflammatory back pain (IBP) symptoms, secondaryOutcomes measure: Physical examination I, secondaryOutcomes measure: Physical examination II, secondaryOutcomes measure: Symptomatic SpA features I, secondaryOutcomes measure: Symptomatic SpA features II, secondaryOutcomes measure: Symptomatic SpA features III, secondaryOutcomes measure: Symptomatic SpA features IV, secondaryOutcomes measure: Symptomatic SpA features V, secondaryOutcomes measure: Symptomatic SpA features VI, secondaryOutcomes measure: Physicians global assessment of disease activity, secondaryOutcomes measure: Magnetic resonance imaging of sacroiliac joints (SIJ) and spine, secondaryOutcomes measure: low dose computed tomography of SIJ and spine, secondaryOutcomes measure: dual energy computed tomography of SIJ, secondaryOutcomes measure: radiography SIJ, secondaryOutcomes measure: Work, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Sleep, secondaryOutcomes measure: Self-efficacy, secondaryOutcomes measure: Objective physical function, secondaryOutcomes measure: Aerobic capacity, otherOutcomes measure: Patient global assessment, otherOutcomes measure: Acceptable state, otherOutcomes measure: Mental state, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 48 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False