Advanced Sensor Based Functional ASsessmenTs in Axial Spondyloarthritis

  • STATUS
    Recruiting
  • participants needed
    20
  • sponsor
    Western Health and Social Care Trust
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Updated on 5 August 2020
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MRI
MRI Scan
biological therapy
axial spondyloarthritis
spondylarthritis

Summary

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

Details
Condition Axial Spondyloarthritis
Age 18years - 80years
Treatment ViMove IMU sensor test
Clinical Study IdentifierNCT04489342
SponsorWestern Health and Social Care Trust
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Diagnosis of axial spondyloarthritis fulfilling ASAS classification criteria
Age 18 years old and <80 years
Fulfilment of local criteria for biologic therapy for axSpA
The subjects should be able to read, write, understand and complete study questionnaires
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
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