ArticlePain medicine (Malden, Mass.)2025
The design and rationale of the Biomarkers for Evaluating Spine Treatments trial: a sequential multiple assignment randomized trial.
Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph
Article in Pain medicine (Malden, Mass.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05396014 (The BEST Trial), which is not on this map. Cited by 5 papers.
0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The BEST Trial: Biomarkers for Evaluating Spine Treatments
Who cites it
5 citing papers in PubMed.
- Baseline characteristics of participants in the Biomarkers for Evaluating Spine Treatments clinical trial: a sequential multiple assignment randomized trial for chronic low back pain†.Pain medicine (Malden, Mass.) · 2025Trial
- From empirical practice to precision medicine: developing a methodology for adjusting traditional Chinese medicine formula dosages based on eight multicenter clinical studies.Frontiers in pharmacology · 2026Article
- Wearable sensor technologies for individuals with back pain: a scoping review.Pain management · 2025Article
- Preclinical perspectives on disorders of the temporomandibular joint: Tracing the past, navigating the present, and shaping the future.The journal of pain · 2025Review
- At-Home Morning Bright Light Treatment for Chronic Nociplastic Pain: Protocol for a Randomized Clinical Trial.JMIR research protocols · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
67 authors.
Matthew C MauckDepartment of Anesthesiology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC 27599, United States.
Kelly S BarthDepartment of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC 29425, United States.
Kevin M BellDepartment of Bioengineering, University of Pittsburgh, Pittsburgh, PA 15260, United States.
Amber K BrooksDepartment of Anesthesiology, Wake Forest University School of Medicine, Winston-Salem, NC 27101, United States.ORCID 0000-0001-9568-1336
Andrea L ChadwickDepartment of Anesthesiology, Pain and Perioperative Medicine, University of Kansas School of Medicine, Kansas City, KS 66160, United States.ORCID 0000-0002-0570-9997
Cameron A GunnCollaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC 27516, United States.ORCID 0009-0000-8707-2936
Robert W HurleyDepartment of Anesthesiology, Wake Forest University School of Medicine, Winston-Salem, NC 27101, United States.
Anastasia IvanovaDepartment of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, United States.ORCID 0000-0003-4321-2073
Sara R PivaDepartment of Physical Therapy, School of Health and Rehabilitation Services, University of Pittsburgh, Pittsburgh, PA 15260, United States.
Michael J SchneiderDepartment of Physical Therapy, School of Health and Rehabilitation Services, University of Pittsburgh, Pittsburgh, PA 15260, United States.
Jeannie F BaileyDepartment of Orthopaedic Surgery, University of California, San Francisco, San Francisco, CA 94143, United States.
Sarah BagaasonCollaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC 27516, United States.
Anna BatorskyCollaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC 27516, United States.ORCID 0000-0001-5644-0951
Jeffrey J BorckardtDepartment of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC 29425, United States.
Anton E BowdenMechanical Engineering Department, Brigham Young University, Provo, UT 84602, United States.ORCID 0000-0003-3124-7551
Timothy S CareyDepartment of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC 27516, United States.
Joel CastellanosDepartment of Anesthesiology, University of California, San Diego, San Diego, CA 92037, United States.
Lucy ChenMGH Center for Translational Pain Research, Massachusetts General Hospital and Harvard Medical School, Boston, MA 02114, United States.
Brooke ChidgeyDepartment of Anesthesiology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC 27599, United States.
Diane DaltonDepartment of Physical Therapy, Sargent College of Health & Rehabilitation Sciences, Boston, MA 02215, United States.
Jonathan S DufourSpine Research Institute, The Ohio State University, Columbus, OH 43210, United States.
Aaron J FieldsDepartment of Orthopaedic Surgery, University of California, San Francisco, San Francisco, CA 94143, United States.
Julie M FritzDepartment of Orthopaedics, University of Utah School of Medicine, Salt Lake City, UT 84108, United States.ORCID 0000-0002-3599-1057
Rachel West GoolsbyCollaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC 27516, United States.
Carol M GrecoDepartment of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, United States.ORCID 0000-0002-3078-2918
Richard E HarrisDepartment of Anesthesiology, Chronic Pain & Fatigue Research Center, University of Michigan, Ann Arbor, Ann Arbor, MI 48105, United States.
Steven HarteDepartment of Anesthesiology, Chronic Pain & Fatigue Research Center, University of Michigan, Ann Arbor, Ann Arbor, MI 48105, United States.
Afton L HassettDepartment of Anesthesiology, Chronic Pain & Fatigue Research Center, University of Michigan, Ann Arbor, Ann Arbor, MI 48105, United States.ORCID 0000-0003-2982-484X
Anna HoffmeyerUrology Section, Department of Surgery, Veterans Affairs Health Care System, Durham, NC 27705, United States.
Sara Jones BerkeleyDepartment of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, United States.ORCID 0009-0001-1041-5715
Chelsea KaplanDepartment of Anesthesiology, Chronic Pain & Fatigue Research Center, University of Michigan, Ann Arbor, Ann Arbor, MI 48105, United States.
Kelley M KidwellDepartment of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI 48109, United States.
Gregory G KnapikSpine Research Institute, The Ohio State University, Columbus, OH 43210, United States.
Michael R KosorokDepartment of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, United States.
Gregorij KurilloDepartment of Orthopaedic Surgery, University of California, San Francisco, San Francisco, CA 94143, United States.
Remy LoboDepartment of Radiology, University of Michigan, School of Medicine, Ann Arbor, MI 48109, United States.
Jeffrey C LotzDepartment of Orthopaedic Surgery, University of California, San Francisco, San Francisco, CA 94143, United States.ORCID 0000-0002-9654-0647
Sean MackeyDepartment of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Palo Alto, CA 94305, United States.
Prasath MageswaranSpine Research Institute, The Ohio State University, Columbus, OH 43210, United States.
Sharmila MajumdarDepartment of Radiology & Biomedical Imaging, University of California, San Francisco, San Francisco, CA 94143, United States.
Jianren MaoMGH Center for Translational Pain Research, Massachusetts General Hospital and Harvard Medical School, Boston, MA 02114, United States.
William S MarrasSpine Research Institute, The Ohio State University, Columbus, OH 43210, United States.
Micah McCumberCollaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC 27516, United States.ORCID 0000-0003-2570-1180
Samuel A McLeanDepartment of Anesthesiology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC 27599, United States.
Wolf MehlingDepartment of Family Community Medicine, University of California, San Francisco School of Medicine, San Francisco, CA 94143, United States.
Ulrike H MitchellDepartment of Exercise Sciences, Brigham Young University, Provo, UT 84604, United States.
Vitaly J NapadowDepartment of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA 02129, United States.
Conor O'NeillDepartment of Orthopaedic Surgery, University of California, San Francisco, San Francisco, CA 94143, United States.
Kushang V PatelDepartment of Anesthesiology and Pain Medicine, University of Washington School of Medicine, Seattle, WA 98195, United States.
Scott PeltierDepartment of Radiology and Biomedical Engineering, University of Michigan School of Medicine, Ann Arbor, MI 48109, United States.
Matthew PsiodaStatistical Innovation, Oncology and Vaccines, GlaxoSmithKline, Durham, NC 27701, United States.
Bryce RowlandCollaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC 27516, United States.
Sean D RundellDepartment of Rehabilitation Medicine, University of Washington, Seattle, WA 98104, United States.ORCID 0000-0003-0782-5999
Andrew SchrepfDepartment of Anesthesiology, Chronic Pain & Fatigue Research Center, University of Michigan, Ann Arbor, Ann Arbor, MI 48105, United States.
John SpergerDepartment of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, United States.
Nam VoDepartment of Orthopaedic Surgery, University of Pittsburgh, Pittsburgh, PA 15213, United States.
Mark S WallaceDepartment of Anesthesiology, University of California, San Diego, San Diego, CA 92037, United States.ORCID 0000-0001-5647-6233
Ajay D WasanDepartment of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15261, United States.ORCID 0000-0002-6394-6077
Tristan E WeaverDepartment of Anesthesiology, The Ohio State University Wexner Medical Center, Columbus, OH 43210, United States.
Kenneth A WeberDepartment of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Palo Alto, CA 94305, United States.ORCID 0000-0002-0916-9174
David A WilliamsDepartment of Anesthesiology, Chronic Pain & Fatigue Research Center, University of Michigan, Ann Arbor, Ann Arbor, MI 48105, United States.
Leslie WilsonDepartment of Clinical Pharmacy, University of California San Francisco, San Francisco, CA 94143, United States.ORCID 0000-0002-3305-8730
Fadel ZeidanDepartment of Anesthesiology, University of California, San Diego, San Diego, CA 92037, United States.
Beibo ZhaoCollaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC 27516, United States.
Kevin J AnstromCollaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC 27516, United States.
Daniel J ClauwDepartment of Anesthesiology, Chronic Pain & Fatigue Research Center, University of Michigan, Ann Arbor, Ann Arbor, MI 48105, United States.
Gwendolyn A SowaDepartment of Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, Pittsburgh, PA 15206, United States.
Funding
Back Pain Consortium (BACPAC) Research Program Data Integration, Algorithm Development and Operations Management CenterU24AR076730 · NIAMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI ANSTROM, KEVIN J, IVANOVA, ANASTASIA · 2019 to 2024
$60.0MInfluence of inflammation-related genetic variants on PT treatment response in a population affected by CLBPU19AR076725 · NIAMS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI SOWA, GWENDOLYN A, VO, NAM V · 2019 to 2023
$21.7MUniversity of Michigan BACPAC Mechanistic Research CenterU19AR076734 · NIAMS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI CLAUW, DANIEL J, HASSETT, AFTON L · 2019 to 2023
$12.2MMechanisms of Action of Peripheral Nerve Stimulation for the Treatment of Chronic Neuropathic PainRM1NS128956 · NINDS · STANFORD UNIVERSITY · PI SANDIP BISWAL, Andrea Lynn Chadwick · 2023 to 2026
$8.6MIntegrating Tailored Postoperative Opioid Tapering and Pain Management Support for Patients on Long-Term Opioid Use Presenting for Spine Surgery (MIRHIQL)R01DA058694 · NIDA · STANFORD UNIVERSITY · PI Jennifer Hah · 2023 to 2026
$4.5MThe Impact of Gender Affirming Hormone Therapy on Pain in Gender Minority AdultsR01NS135833 · NINDS · UNIVERSITY OF KANSAS MEDICAL CENTER · PI Andrea Lynn Chadwick · 2024 to 2026
$1.9MImmune mechanisms of Vitamin D in a randomized controlled trial to reduce chronic pain after burn.K23AT011389 · NCCIH · UNIV OF NORTH CAROLINA CHAPEL HILL · PI MAUCK, MATTHEW CHRISTOPHER · 2022 to 2024
$525kRandomized Controlled Trial of Vitamin D to reduce racial disparity in chronic pain following Motor Vehicle CollisionR21MD016467 · NIMHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI MCLEAN, SAMUEL A. · 2021 to 2022
$479kDepartment of Defense W81XWH-21-PRMRP-CTA [PR212158]NCCIH NIH HHS K23 AT011389NIAMS NIH HHS U19 AR076725NIAMS NIH HHS U19 AR076734NIAMS NIH HHS U24 AR076730NIDA NIH HHS R01 DA058694NIH HHS 1K23AT011389-01A1NIH HHS 1R21MD016467-01NIH HHS R01DA058694-01NIH HHS R01NS135833-01A1NIH HHS RM1NS128956-01A1NIH HHS U24AR076730NIMHD NIH HHS R21 MD016467NINDS NIH HHS R01 NS135833NINDS NIH HHS RM1 NS128956The Back Pain Consortium
Abstract
objectiveChronic low back pain (cLBP) is a common condition that impacts quality of life and function. There are many evidence-based treatments to address cLBP; however, treatment effects are modest, perhaps in part due to individual variation in treatment response. The Biomarkers for Evaluating Spine Treatments (BEST) trial was designed as the collaborative centerpiece of the Back Pain Consortium (BACPAC) research program. This consortium was sponsored by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) as part of the Helping to End Addiction Long-term (HEAL) Initiative.
designThe BEST trial was a sequential multiple assignment randomized trial (SMART) designed with the primary goal of identifying in whom different treatments show optimal response. The primary focus of the study was to use patient features, including biomarkers and phenotypic measures, to identify subsets of persons with cLBP who respond best to specific common treatments.
methodsFour interventions were chosen for the trial: Enhanced Self-Care, Acceptance and Commitment Therapy, Duloxetine, and Evidence-Based Exercise and Manual Therapy. Following a run-in period and baseline assessment, participants were randomized to 1 of the 4 treatments for the first 12-week intervention period. Participants were reassessed and based on their self-reported response to initial treatment, continued that initial treatment, were augmented with an additional randomly assigned treatment, or were switched to a new treatment.
conclusionThis trial was designed to deliver rich phenotypic data that will both potentially aid in the discovery of phenotypic characteristics that predict treatment response and provide a greater mechanistic understanding of cLBP. CLINICAL TRIAL REGISTRATION NUMBER: The Biomarkers for Evaluating Spine Treatments (BEST) trial is registered on ClinicalTrials.gov (Registration number: NCT05396014; https://clinicaltrials.gov/study/NCT05396014).
Indexed as
Chronic PainLow Back PainAdultBiomarkersDuloxetine HydrochlorideExercise TherapyFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicTreatment OutcomeBiomarkersDuloxetine Hydrochloridechronic low back painchronic painclinical triallow back painphenotypingSMART
Identifiers
What Socratic holds
Textmetadata
LicenceCC BY-NC
Read underepoch 390
Registered trials
NCT05396014ClinicalTrials.gov
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.