SPINA – a novel international spine physiotherapy registry to inform clinical phenotypes, recovery pathways and prediction of outcomes for precision interventions

To create a registry to enable international big data for understanding and development of precision interventions for spinal pain to improve patient care pathways and outcomes. Objectives are to: 1] create a longitudinal minimum core dataset for spinal problems, 2] facilitate extended datasets for spinal problems, 3] establish a source for recruitment of potential participants for research.

Prospective observational longitudinal registry with data collection (commenced 1st August 2023) at defined intervals (intake, 1 3 6 and 12 months, yearly) through an electronic platform (EmPower Health Research). The minimum core dataset was informed by the Report of the NIH Task Force on Research Standards for Low Back Pain, research-based recommendations for registry construction, literature reviews and authentic partnerships with patients and clinicians. Adults (≥18 years) experiencing spinal pain/symptoms (neck, upper/mid-back, low back) of musculoskeletal cause are eligible to participate and recruited through contact with a physiotherapist or responding to advertisements online/healthcare locations. For patients recruited through physiotherapist contact, parallel clinician data (intake, 1 month) are collected. Patient data include demographics, symptom characteristics, functional interference, resilience, work status etc. Clinician data include nature of spinal pain, physical examination findings, physiotherapy diagnosis etc. Extended datasets include physical measures and biomarkers. A system of reminders including email, text, and phone calls reduces loss to follow up. Planned recruitment is n=20,000 patients over 20 years.

SPINA allows patients and clinicians ownership over their data. Patients download their data trends over time. Physiotherapy clinical sites download their clinic data trends over time. Current recruitment is from Canada, awaiting ethical approval in the UK and Australia. Data analysis will include pre-post physiotherapy intervention analyses, and development and validation of models for predicting outcome from low back, cervical and thoracic problems using a range of outcomes (e.g. pain and disability) and outcomes important to patients, at a range of timepoints.

This physiotherapy-focused registry is the first of its kind to support spine research enabling investigation of clinical phenotypes, recovery pathways, identification of risk, and prediction of outcomes to inform precision intervention. SPINA, for the first time enables research across lumbar, cervical and thoracic regions.

Longitudinal tracking will allow for care pathways to be visualized through data for model development and systems-based improvement. SPINA also forms the foundation for parallel data-banking of biomarkers and physical measures for comprehensive profiling of spinal pain. It is anticipated that SPINA will be a valuable resource internationally for researchers and clinicians.