Trial reportPain medicine (Malden, Mass.)2025
Baseline characteristics of participants in the Biomarkers for Evaluating Spine Treatments clinical trial: a sequential multiple assignment randomized trial for chronic low back pain†.
Registry-linked trialAbstract readClinical Trial, Phase IVRandomized Controlled Trial
In one paragraph
Trial report 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 1 paper.
0numbers the graph read from it
0cells of the map it votes in
1citing 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
1 citing paper in PubMed.
- Biomaterials for intervertebral disc regeneration: Niche reprogramming, precision therapeutics, and structural reconstruction.Bioactive materials · 2027Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
87 authors.
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.
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 15261, United States.
Amber K BrooksDepartment of Anesthesiology, Wake Forest University School of Medicine, Winston-Salem, NC 27157, 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
Annika ClevenCollaborative 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.
Robert W HurleyDepartment of Anesthesiology, Wake Forest University School of Medicine, Winston-Salem, NC 27157, United States.
Sean MackeyDepartment of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States.
Kushang V PatelDepartment of Anesthesiology and Pain Medicine, University of Washington School of Medicine, Seattle, WA 98195, United States.
Sara R PivaDepartment of Physical Therapy, School of Health and Rehabilitation Services, University of Pittsburgh, Pittsburgh, PA 15260, United States.
Michael J SchneiderDoctor of Chiropractic Program, School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA 15260, United States.
Fatima Al-KadhiDepartment of Anesthesiology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC 27514, United States.
Bernice Asante-NketiahDepartment of Anesthesiology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC 27514, 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 84601, United States.ORCID 0000-0003-3124-7551
Timothy S CareyResearch Professor of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, United States.
Joel CastellanosDepartment of Anesthesiology, University of California, San Diego, San Diego, CA 92120, 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 27514, 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.
Jaclyn L EbertingDepartment of Anesthesiology, Wake Forest University School of Medicine, Winston-Salem, NC 27157, United States.
Seth M EllerDepartment of Anesthesiology, Wake Forest University School of Medicine, Winston-Salem, NC 27157, United States.
Aaron J FieldsDepartment of Orthopaedic Surgery, University of California, San Francisco, San Francisco, CA 94143, United States.
Julie M FritzDepartment of Physical Therapy & Athletic Training, University of Utah, College of Health, Salt Lake City, UT 84108, United States.ORCID 0000-0002-3599-1057
Amber FuDepartment of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States.
Inam GhulamhussainCollaborative 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.
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
Sarah GrimSpine Research Institute, The Ohio State University, Columbus, OH 43210, United States.
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
Lindsay HanesSpine Research Institute, The Ohio State University, Columbus, OH 43210, United States.
Richard E HarrisSusan Samueli Integrative Health Institute, School of Medicine, University of California at Irvine, Irvine, CA 92697, United States.
Steven E HarteDepartment of Anesthesiology, Chronic Pain & Fatigue Research Center, University of Michigan, Ann Arbor, MI 48106, United States.
Afton L HassettDepartment of Anesthesiology, Chronic Pain & Fatigue Research Center, University of Michigan, Ann Arbor, MI 48106, United States.ORCID 0000-0003-2982-484X
Kinsey HeltonCollaborative 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 HoffmeyerUrology Section, Department of Surgery, Veterans Affairs Health Care System, Durham, NC 27705, 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 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, MI 48106, 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.
David LiCollaborative 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.
Remy LoboDepartment of Radiology, University of Michigan School of Medicine, Ann Arbor, MI 48105, United States.
Joseph LongDepartment of Anesthesiology, Back and Pain Center, University of Michigan, Ann Arbor, MI 48108, United States.
Jeffrey C LotzDepartment of Orthopaedic Surgery, University of California, San Francisco, San Francisco, CA 94143, United States.ORCID 0000-0002-9654-0647
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.ORCID 0000-0002-0201-871X
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.
Lance M McCrackenDepartment of Psychology, Uppsala University, Uppsala 751 42, Sweden.ORCID 0000-0002-9734-0153
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 27514, United States.
Miranda McMillanDepartment of Anesthesiology, Pain and Perioperative Medicine, University of Kansas School of Medicine, Kansas City, KS 66160, United States.
Wolf MehlingDepartment of Family Community Medicine, University of California, San Francisco School of Medicine, San Francisco, CA 94110, United States.
Rafael MendozaDepartment of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC 29425, United States.
Ulrike H MitchellDepartment of Exercise Sciences, Brigham Young University, Provo, UT 84602, United States.
Vitaly 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.
Sydnee PearsonDepartment of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC 29425, United States.
Scott PeltierDepartment of Radiology, University of Michigan School of Medicine, Ann Arbor, MI 48105, United States.
Sean D RundellDepartment of Rehabilitation Medicine, University of Washington, Seattle, WA 98104, United States.ORCID 0000-0003-0782-5999
Sonja RyserDepartment of Rehabilitation Medicine, University of Washington, Seattle, WA 98104, United States.
Andrew SchrepfDepartment of Anesthesiology, Chronic Pain & Fatigue Research Center, University of Michigan, Ann Arbor, MI 48106, United States.
Emily SchulzeDepartment of Anesthesiology, Pain and Perioperative Medicine, University of Kansas School of Medicine, Kansas City, KS 66160, 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 92120, United States.ORCID 0000-0001-5647-6233
Abigail M WamplerDepartment of Anesthesiology, Pain and Perioperative Medicine, University of Kansas School of Medicine, Kansas City, KS 66160, United States.
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 School of Medicine, Stanford, CA 94305, United States.ORCID 0000-0002-0916-9174
Lauren WilcoxDepartment of Physical Therapy, School of Health and Rehabilitation Services, University of Pittsburgh, Pittsburgh, PA 15260, United States.
David A WilliamsDepartment of Anesthesiology, Chronic Pain & Fatigue Research Center, University of Michigan, Ann Arbor, MI 48106, United States.
Leslie WilsonDepartment of Clinical Pharmacy, University of California San Francisco, San Francisco, CA 94143, United States.ORCID 0000-0002-3305-8730
Jacqueline E WooDepartment of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States.
Fadel ZeidanDepartment of Anesthesiology, University of California, San Diego, San Diego, CA 92120, 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.
Brianna ZhouDepartment of Anesthesiology and Pain Medicine, University of Washington School of Medicine, Seattle, WA 98195, 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, MI 48106, United States.
Gwendolyn A SowaDepartment of Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, United States.
Matthew C MauckDepartment of Anesthesiology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC 27514, 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
$60.0MIncreasing Participant Diversity in a 'Sequenced-Strategy to Improve Outcomes in people with Knee Osteoarthritis Pain (SKOAP)UH3AR077360 · NIAMS · JOHNS HOPKINS UNIVERSITY · PI CAMPBELL, CLAUDIA MICHELLE, CASTILLO, RENAN C · 2020 to 2023
$13.8MUniversity 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
$8.6MUW Core Center for Clinical Research of Musculoskeletal ConditionsP30AR072572 · NIAMS · UNIVERSITY OF WASHINGTON · PI JEFFREY G JARVIK, Pradeep Suri · 2017 to 2026
$8.3MMIRHIQL Resource Center for Improving Quality of Life with Chronic Pain (MRC)R24DA058606 · NIDA · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI ADAMS, MEREDITH C. B., HURLEY, ROBERT WILLSON · 2023 to 2023
$6.0MIntegrating 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
$4.5MA Mobile Health Behavior Intervention to Reduce Pain and Improve Health-III (MORPH-III)R01AG082777 · NIA · WAKE FOREST UNIVERSITY · PI Amber Keller Brooks, Jason Fanning · 2024 to 2026
$3.6MThe 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
$1.9MWearable nanocomposite sensor system for diagnosing mechanical sources of low back pain and guiding rehabilitationUH3AR076723 · NIAMS · BRIGHAM YOUNG UNIVERSITY · PI BOWDEN, ANTON E. · 2021 to 2021
$1.2MWorkforce Innovation in Data Science, Education, and Addiction Research (WISER)R25DA061740 · NIDA · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI MEREDITH C. B. ADAMS, Amber Keller Brooks · 2024 to 2026
$405kCystic Fibrosis Foundation FRIEDM22A0-IHEALNIAMS NIH HHS 1U24AR076730NIAMS NIH HHS P30 AR072572NIAMS NIH HHS U19 AR076734NIAMS NIH HHS U24 AR076730NIAMS NIH HHS UH3 AR076723NIAMS NIH HHS UH3 AR077360NIA NIH HHS R01 AG082777NIDA NIH HHS R01 DA058694NIDA NIH HHS R24 DA058606NIDA NIH HHS R25 DA061740NIH HHS 1R01AG082777-01A1NIH HHS 1R25DA061740-01NIH HHS 1U24AR076730NIH HHS R01DA058694-01NIH HHS R01NS135833-01A1NIH HHS R25DA061740NIH HHS RM1NS128956-01A1NIH HHS U24DA058606NIH HHS UH3AR077360NINDS NIH HHS R01 NS135833NINDS NIH HHS RM1 NS128956Swing Therapeutics and Scilex PharmaceuticalsThe Back Pain ConsortiumU.S. Department of Defense W81XWH-21-PRMRP-CTA (PR212158)
Abstract
objectiveChronic low back pain (cLBP) is a significant public health problem in the United States. A method to identify treatments that are most likely effective for an individual patient based on their unique characteristics is needed.
methodsThe Biomarkers for Evaluating Spine Treatments (BEST) Trial is a sequential, multiple assignment, randomized trial designed to estimate an optimal treatment or combination of treatments to reduce pain intensity and interference at 24 weeks in individuals with cLBP.
resultsWe describe the patient-reported characteristics of the BEST Trial at the Baseline visit. Data collection for extensive required phenotyping is reported. We analyzed the run-in period of the BEST Trial to evaluate predictors of run-in failure. The BEST Trial enrolled 1019 participants and randomized 805 participants (61.6% female, mean age 50.4, 12.5% Black or African American) to the first stage of treatment. We collected extensive required phenotyping on all 805 randomized BEST Trial participants, and additional optional phenotyping on 510 (63.4%) participants.
conclusionsThe BEST Trial successfully enrolled a racially and geographically diverse sample of chronic low back pain patients and completed rich phenotypic assessments to inform our primary goal of identifying in whom different treatments show optimal response. We demonstrated the feasibility of collecting extensive phenotypic assessments in a multi-site clinical trial 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 PainAdultAgedBiomarkersFemaleHumansMaleMiddle AgedPain MeasurementTreatment OutcomeBiomarkersbaseline characteristicschronic low back painclinical trialphenotypingSMART trial
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.