Baseline characteristics of participants in the Biomarkers for Evaluating Spine Treatments clinical trial: a sequential multiple assignment randomized trial for chronic low back pain - Scorecard - MDSpire

Baseline characteristics of participants in the Biomarkers for Evaluating Spine Treatments clinical trial: a sequential multiple assignment randomized trial for chronic low back pain

  • By

  • Bryce Rowland

  • Kelly S Barth

  • Kevin M Bell

  • Amber K Brooks

  • Andrea L Chadwick

  • Annika Cleven

  • Robert W Hurley

  • Sean Mackey

  • Kushang V Patel

  • Sara R Piva

  • Michael J Schneider

  • Fatima Al-Kadhi

  • Bernice Asante-Nketiah

  • Sarah Bagaason

  • Anna Batorsky

  • Jeffrey J Borckardt

  • Anton E Bowden

  • Timothy S Carey

  • Joel Castellanos

  • Lucy Chen

  • Brooke Chidgey

  • Diane Dalton

  • Jonathan S Dufour

  • Jaclyn L Eberting

  • Seth M Eller

  • Aaron J Fields

  • Julie M Fritz

  • Amber Fu

  • Inam Ghulamhussain

  • Rachel West Goolsby

  • Carol M Greco

  • Sarah Grim

  • Cameron A Gunn

  • Lindsay Hanes

  • Richard E Harris

  • Steven E Harte

  • Afton L Hassett

  • Kinsey Helton

  • Anna Hoffmeyer

  • Anastasia Ivanova

  • Sara Jones Berkeley

  • Chelsea Kaplan

  • Kelley M Kidwell

  • Gregory G Knapik

  • Michael R Kosorok

  • Gregorij Kurillo

  • David Li

  • Remy Lobo

  • Joseph Long

  • Jeffrey C Lotz

  • Prasath Mageswaran

  • Sharmila Majumdar

  • Jianren Mao

  • William S Marras

  • Lance M McCracken

  • Micah McCumber

  • Samuel A McLean

  • Miranda McMillan

  • Wolf Mehling

  • Rafael Mendoza

  • Ulrike H Mitchell

  • Vitaly Napadow

  • Conor O'Neill

  • Sydnee Pearson

  • Scott Peltier

  • Sean D Rundell

  • Sonja Ryser

  • Andrew Schrepf

  • Emily Schulze

  • John Sperger

  • Nam Vo

  • Mark S Wallace

  • Abigail M Wampler

  • Ajay D Wasan

  • Tristan E Weaver

  • Kenneth A Weber

  • Lauren Wilcox

  • David A Williams

  • Leslie Wilson

  • Jacqueline E Woo

  • Fadel Zeidan

  • Beibo Zhao

  • Brianna Zhou

  • Kevin J Anstrom

  • Daniel J Clauw

  • Gwendolyn A Sowa

  • Matthew C Mauck

  • August 5, 2025

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Clinical Scorecard: Participant Baseline Characteristics in the Biomarkers for Evaluating Spine Treatments Trial: A Sequential Multiple Assignment Randomized Study for Chronic Low Back Pain

At a Glance

CategoryDetail
ConditionChronic low back pain (cLBP)
Key MechanismsBiomarker-based phenotyping across psychosocial, biomechanical, omics, inflammatory, imaging, and social determinants to tailor treatment
Target PopulationAdults with chronic low back pain, racially and geographically diverse
Care SettingMulti-site clinical trial settings including clinical contact, electronic health records, and community outreach

Key Highlights

  • The BEST Trial enrolled 1019 participants and randomized 805 to initial treatment, collecting extensive phenotypic data.
  • The trial used a sequential, multiple assignment randomized trial (SMART) design to identify optimal individualized treatments.
  • Four evidence-based interventions were tested: Enhanced Self Care, Acceptance and Commitment Therapy, Evidence-Based Exercise and Manual Therapy, and Duloxetine.

Guideline-Based Recommendations

Diagnosis

  • Use comprehensive phenotypic and biomarker assessments to characterize cLBP patients.
  • Employ broad inclusion criteria to ensure representative and generalizable patient populations.

Management

  • Consider precision medicine approaches tailoring treatment based on patient-specific biomarkers and phenotypes.
  • Utilize sequential treatment assignments to optimize individual patient response.

Monitoring & Follow-up

  • Implement run-in periods to assess participant adherence and suitability before randomization.
  • Collect longitudinal data on pain intensity and interference over 24 weeks.

Risks

  • Recognize that many patients may not respond to initial treatments and require sequential reassignment.
  • Account for potential run-in period non-completion when designing trials and interpreting results.

Patient & Prescribing Data

Adults with chronic low back pain enrolled in a multi-site clinical trial with diverse demographics.

Four treatments with prior evidence of efficacy were tested; the trial aims to identify which treatments or combinations are optimal for individual phenotypes.

Clinical Best Practices

  • Collect extensive biomarker and phenotypic data across multiple domains to inform treatment tailoring.
  • Use SMART trial designs to adapt treatment based on individual response.
  • Recruit diverse patient populations to enhance generalizability of findings.

References

Original Source(s)

Baseline characteristics of participants in the Biomarkers for Evaluating Spine Treatments clinical trial: a sequential multiple assignment randomized trial for chronic low back pain

  • by Bryce Rowland, Kelly S Barth, Kevin M Bell, Amber K Brooks, Andrea L Chadwick, Annika Cleven, Robert W Hurley, Sean Mackey, Kushang V Patel, Sara R Piva, Michael J Schneider, Fatima Al-Kadhi, Bernice Asante-Nketiah, Sarah Bagaason, Anna Batorsky, Jeffrey J Borckardt, Anton E Bowden, Timothy S Carey, Joel Castellanos, Lucy Chen, Brooke Chidgey, Diane Dalton, Jonathan S Dufour, Jaclyn L Eberting, Seth M Eller, Aaron J Fields, Julie M Fritz, Amber Fu, Inam Ghulamhussain, Rachel West Goolsby, Carol M Greco, Sarah Grim, Cameron A Gunn, Lindsay Hanes, Richard E Harris, Steven E Harte, Afton L Hassett, Kinsey Helton, Anna Hoffmeyer, Anastasia Ivanova, Sara Jones Berkeley, Chelsea Kaplan, Kelley M Kidwell, Gregory G Knapik, Michael R Kosorok, Gregorij Kurillo, David Li, Remy Lobo, Joseph Long, Jeffrey C Lotz, Prasath Mageswaran, Sharmila Majumdar, Jianren Mao, William S Marras, Lance M McCracken, Micah McCumber, Samuel A McLean, Miranda McMillan, Wolf Mehling, Rafael Mendoza, Ulrike H Mitchell, Vitaly Napadow, Conor O'Neill, Sydnee Pearson, Scott Peltier, Sean D Rundell, Sonja Ryser, Andrew Schrepf, Emily Schulze, John Sperger, Nam Vo, Mark S Wallace, Abigail M Wampler, Ajay D Wasan, Tristan E Weaver, Kenneth A Weber, Lauren Wilcox, David A Williams, Leslie Wilson, Jacqueline E Woo, Fadel Zeidan, Beibo Zhao, Brianna Zhou, Kevin J Anstrom, Daniel J Clauw, Gwendolyn A Sowa, Matthew C Mauck

  • August 5, 2025

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