AxiaL spondyloarthritis Musculoskeletal Diseases
Conditions
Interventions
Current interventions as of 31/12/2025:
Patients (aged 16-50 years with chronic back pain of =3 consecutive months’ duration and onset before 45 years) will be identified at their GP site (which will
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Age
16 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Aged 16-50 years with the onset of chronic back (cervical/thoracic/lumbar) pain before 45 years 2. Current back pain and at least 3 consecutive months of chronic back pain in the last 12 months 3. Ability to provide written/electronic informed consent 4. Willingness and ability to undergo study assessments (i.e., clinical assessment, X-ray, MRI, blood sample collection)
Exclusion criteria
Exclusion criteria: 1. Existing diagnosis of axSpA 2. Existing diagnosis of inflammatory arthritis 3. GPC deems unsuitable 4. Radiation of leg pain below the knee (i.e. neuralgia/sciatica) 5. Contraindications to MRI, eg: 5.1. Pacemaker 5.2. Other ferrous metal in situ 5.3. Pregnancy (up to 12 months postpartum) 5.4. Claustrophobia 6. Suspected red flags in the history or clinical examination that may indicate further investigation or referral for possible serious underlying pathology: 6.1. Cauda Equina Syndrome 6.2. Spinal Fracture 6.3. Cancer 6.4. Bone/disc infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Sensitivity, specificity, likelihood ratio, calibration and discrimination of the Baraliakos strategy at baseline 2. Sensitivity, specificity, likelihood ratio, calibration and discrimination of the revised referral strategy at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sensitivity, specificity, likelihood ratio, calibration and discrimination of the Baraliakos strategy at baseline 2. Sensitivity, specificity, likelihood ratio, calibration and discrimination of the revised referral strategy at baseline 3. Sensitivity, specificity, likelihood ratio, calibration and discrimination of each strategy at baseline 4. Clinical effectiveness to be assessed via predictive performance measures (sensitivity, specificity, likelihood ratio, calibration and discrimination) comparing each strategy at baseline. Acceptability to be ascertained through discussion with stakeholders 5. Sensitivity, specificity, likelihood ratio, calibration and discrimination of NASS questionnaire at baseline 6. Diagnosis of AxSpa in a younger back pain cohort at baseline 7. Sensitivity, specificity, likelihood ratio, calibration and discrimination of individual screening variables at baseline | — |
Countries
England, United Kingdom
Contacts
Public ContactIDEAL Trial Management Team
Outcome results
None listed