Axial spondyloarthritis axial spondyloarthritis, ankylosing spondylitis
Conditions
Interventions
No experimental intervention is administered. All treatments are prescribed as part of routine clinical care. The study involves non-invasive IMU-based spinal mobility testing and standard clinical as
Sponsors
Zuyderland
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: IC1. Diagnosis of axial spondyloarthritis (r/nr-axSpA) and fulfilling ASAS classification criteria.IC2. Age =18 years old and <80 years.IC3. Indication for treatment with b/tsDMARD in routine clinical practice based on shared decision between patient and treating physician with fulfilment of local criteria for b/tsDMARD therapy for axSpA.IC4. The subjects should be able to read, write, understand and complete study questionnaires.IC5. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study.
Exclusion criteria
Exclusion criteria: EC1. Severely restricted hip movement (less than 20 degrees rotation in either hip).EC2. History of previous clinical (symptomatic) vertebral fracture.EC3. History of previous spinal surgery.EC4. Structural scoliosis with a Cobb angle =20 degrees on available anteroposterior spine radiographsEC5. A clearly visible spinal deformity on available anteroposterior or lateral radiographs that is expected to substantially restrict physiological spinal mobilityEC6. Pregnant or breastfeeding women.EC7. Evidence of extensive bony ankylosis of the spine on available radiographs of the spine.EC8. Any severe skin conditions that would prevent the sensors from being applied to the skin.EC9. Having a pacemaker.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To validate the IMU axSpA Metrology Index (IMU-ASMI) in an independent cohort according to the Outcome Measures in Rheumatology (OMERACT) filter (truth, discrimination and feasibility). | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate whether the IMU-ASMI has superior measurement properties (e.g. discrimination) to BASMI in the assessment of spinal mobility;To assess which measurements in the IMU-ASMI are more responsive and thereby assess whether or not the IMU-ASMI score needs to be weighted to improve overall responsiveness;To evaluate the reliability and responsiveness of different versions of the IMU-ASMI, with different weights to the components, to select the optimal final version of IMU-ASMI for use in clinical trials;To investigate the effect of age, symptom duration and radiographic damage (mSASSS) on the responsiveness of IMU-ASMI and its components;To assess the effect of baseline spinal mobility on the responsiveness of the IMU-ASMI;To assess the relationship between changes in spinal mobility and changes in disease activity and in functional ability;To assess the relationship between changes in spinal mobility and changes in physical activity;To assess the relationship between changes in spinal mobility and changes in overall functioning and health;To investigate the measurement properties of the different IMU-ASMIs versions in r-axSpA and nr-axSpA, separately;To investigate the measurement properties of BASMI and IMU-ASMI in a selected population of patients with spinal mobility impairment at baseline.To investigate whether kinesiophobia impacts spinal mobility and functional ability. | — |
Countries
France, Netherlands, Turkey, United Kingdom
Contacts
Public ContactS Ramiro
Zuyderland
Outcome results
None listed