Baseline characteristics of participants in the Biomarkers for Evaluating Spine Treatments clinical trial: a sequential multiple assignment randomized trial for chronic low back pain - Report - 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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Baseline Characteristics in the BEST Trial for Chronic Low Back Pain

Overview

The BEST Trial enrolled 1019 participants with chronic low back pain, randomizing 805 to initial treatments and collecting extensive phenotypic data. The cohort was racially and geographically diverse, with comprehensive biomarker assessments to enable precision medicine approaches for treatment tailoring.

Background

Chronic low back pain (cLBP) is a leading cause of disability and healthcare expenditure in the United States. Despite existing treatments, many patients experience persistent pain due to ineffective therapies. Precision medicine approaches using biomarkers to tailor treatments have potential to improve outcomes. The BEST Trial was designed as a sequential, multiple assignment randomized trial to identify optimal treatments based on individual phenotypic biomarkers and treatment responses.

Data Highlights

CharacteristicValue
Number enrolled1019
Number randomized805
Female participants61.6%
Mean age50.4 years
Black or African American12.5%
Participants with optional phenotyping510 (63.4%)

Key Findings

  • The trial successfully enrolled a racially and geographically diverse sample of cLBP patients.
  • Extensive required phenotyping was completed on all randomized participants, with optional phenotyping on over 60%.
  • The run-in period was used to evaluate predictors of non-completion to assess study design feasibility.
  • Four evidence-based interventions were included: Enhanced Self Care, Acceptance and Commitment Therapy, Evidence-Based Exercise and Manual Therapy, and Duloxetine.
  • The trial design allows for biomarker discovery without pre-specifying hypotheses, supporting precision medicine approaches.

Clinical Implications

The BEST Trial demonstrates the feasibility of collecting comprehensive biomarker data in a multi-site cLBP clinical trial, enabling future identification of patient phenotypes that predict optimal treatment responses. Clinicians may anticipate more personalized treatment strategies emerging from such precision medicine research, potentially improving pain outcomes and reducing ineffective treatment trials.

Conclusion

The BEST Trial provides a richly phenotyped, diverse cohort of cLBP patients, laying the groundwork for biomarker-driven precision treatment approaches. Its design and baseline data support future analyses to optimize individualized care for chronic low back pain.

References

  1. BEST Trial ClinicalTrials.gov NCT05396014 -- Biomarkers for Evaluating Spine Treatments Trial

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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