Advanced Sensor Based Functional ASsessmenTs in Axial Spondyloarthritis

Recruiting

• Conditions: Axial Spondyloarthritis

• Registration Number: NCT04489342
• Lead Sponsor: Western Health and Social Care Trust

Brief Summary

This is an observational study using Inertial Measurement Unit (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.

Detailed Description

We will study 20 participants with active axial spondyloarthritis (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 Sacroiliac (SI) joints - modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) scoring

2. Record standard Patient recorded outcomes (PROs): Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Global (BASG), Bath Ankylosing Spondylitis Metrology Index (BASMI), Bath Ankylosing Spondylitis Functional Index (BASFI), Ankylosing Spondylitis Disease Activity Score (ASDAS), Ankylosing Spondylitis Disease Activity Score Health Index (ASAS-HI), Euroquol 3 level health assessment (EQ5D-3L), work productivity and activity impairment questionnaire (WPAI), Short QUestionnaire to ASsess Health enhancing physical activity (SQUASH),

3. Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP)

4. IMU sensor tests in clinic for range of motion (ROM) in cervical, thoracic and lumbar spine.

5. IMU sensor tests at home for standardised function testing

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2020-07-24
• Study First Submitted QC: 2020-07-24
• Study First Posted: 2020-07-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-25
• Primary Completion: 2026-01-07
• Study Completion: 2026-02-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

1. Safety contra-indication for biologic drug therapy.
2. Severely restricted hip movement (less than 20 degrees rotation in either hip).
3. History of previous clinical (symptomatic) vertebral fracture.
4. History of previous spinal surgery.
5. History of previous hip replacement surgery.
6. Major scoliosis deformity (in the opinion of the investigator).
7. Safety contra-indication for MRI assessment.
8. Previous biologic agent within 2 months.
9. Pregnant or breast-feeding women.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in composite IMU sensor based metrology index (IMU-ASMI)	4 months	Change in AxSpA metrology index based on sensor tests of Range of Movement (i.e. spinal mobility). Scale 0-10, with 10 being severe loss of spinal mobility.

Secondary Outcome Measures

Name	Time	Method
Change in Assessment of Spondyloarthritis International Society Response Criteria (ASAS20)	4 months	Change in axSpA disease activity response - 20% improvement is regarded as minimum improvement in at least three of Patient global assessment, Pain assessment, BASFI and Inflammation (last two questions of BASDAI)
Change in Bath Ankylosing Spondylitis Metrology Index (BASMI)	4 months	Change in traditional metrology index of spinal mobility. Scale 0-10, with 10 being severe loss of spinal mobility.
Change in modified Stoke Ankylosing Spondylitis Spine Score (mSASSS)	4 months	Change in MRI score of inflammation. Range 0-72 the sum of scores for 24 vertebral edges in the lumbar and cervical regions, higher represents more spinal damage.
Change in Sit to Stand Test Scores	4 months	Change in standardised function score. Time taken to complete 5 sit to stand actions from a seated position on a chair at standard height.
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	4 months	Change in axSpA disease activity. BASDAI scale 0-10, 10 representing high disease activity
Change in Bath Ankylosing Spondylitis Functional Index (BASFI)	4 months	Change in traditional questionnaire function assessment 0-10 scale, 10 representing a high degree of functional impairment

Trial Locations

Locations (1)

Department of Rheumatology, Altnagelvin Hospital; 🇬🇧 Londonderry, N.Ireland, United Kingdom