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Advanced Sensor Based Functional ASsessmenTs in Axial Spondyloarthritis

Advanced Sensor Based Functional ASsessmenTs in Axial Spondyloarthritis

Recruiting
18-80 years
All
Phase N/A

Overview

This is an observational study using IMU sensors to measure the effects of biological therapy on spinal mobility and function in axial spondyloarthritis. Participants will undergo MRI scans before and after therapy in parallel to the sensor tests to establish correlation between changes in inflammatory signs and changes in spinal mobility.

Description

We will study 20 participants with active axSpA who are about to start biologic therapy as part of routine care. In brief, we will carry out the following assessments before and after

therapy
  1. MRI of spine and SI joints - mSASSS scoring
  2. Record standard PROs: BASDAI, BASG, BASMI, BASFI, ASDAS, ASAS-HI, EQ5D-3L, WPAI, SQUASH,
  3. ESR, CRP
  4. IMU sensor tests in clinic for ROM in cervical, thoracic and lumbar spine.
  5. IMU sensor tests at home for standardised function testing

Eligibility

Inclusion Criteria:

  1. Diagnosis of axial spondyloarthritis fulfilling ASAS classification criteria.
  2. Age 18 years old and <80 years.
  3. Fulfilment of local criteria for biologic therapy for axSpA.
  4. The subjects should be able to read, write, understand and complete study questionnaires.
  5. 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 are willing to participate in the study.

Exclusion Criteria:

EC1. Safety contra-indication for biologic drug therapy. EC2. Severely restricted hip movement (less than 20 degrees rotation in either hip).

EC3. History of previous clinical (symptomatic) vertebral fracture. EC4. History of previous spinal surgery. EC5. History of previous hip replacement surgery. EC6. Major scoliosis deformity (in the opinion of the investigator). EC7. Safety contra-indication for MRI assessment. EC8. Previous biologic agent within 2 months. EC9. Pregnant or breast-feeding women.

Study details
    Axial Spondyloarthritis

NCT04489342

Western Health and Social Care Trust

5 August 2020

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