Clinical Core
Clinical Core:
LEADS
Conor O’Neill, MD Clinical Core Director, UCSF Director of the multidisciplinary spine service
Dennis Black, PhD Co-Director, Epidemiologist/Biostatistician, UCSF Head of chronic diseases division
Patricia Zheng, MD Co-Director, UCSF Specialist in physical medicine and rehabilitation
AIMS
To identify factors associated with response to cLBP treatment and heterogeneity of treatment effects.
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Design/perform a prospective, multicenter, longitudinal Clinical Cohort Study, n=400, capable of supporting deep phenotyping efforts of cLBP patients based on combined biopsychosocial variables.
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Design/perform a large site-less Digital eCohort Study, n=5000. This data will allow for testing and adoption of machine learning techniques reliant on large datasets to generate novel cLBP phenotyping algorithms.
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Develop a large central cLBP Data Warehouse (DW) to organize, integrate, maintain, and archive REACH-related data; this DW will be a pivotal data resource for the REACH research project, other members of the BACPAC consortium, and future cLBP researchers.
APPROACH
ComeBACK Study
Longitudinal multicenter cohort
N=400
4 clinical sites
Visits every 6 mos with up to 4 yrs of follow-up
Measurements:
NIH Pain Consortium minimum dataset
PROMIS-29
MRI (quantitative, MRS)
Spine exam/Quantitative Sensory Testing (QST)
Physical function testing
Genetic/biomarker testing & biospecimen archive
BackHome Study
eCohort
N=5000
Site-less
Enrollment/eConsent & potential f/u online-only
Collection of self-reported data and EHR data
Measurements:
NIH Pain Consortium minimum dataset
PROMIS-29
eREACH Engagement Platform