Baseline characteristics of participants in the Biomarkers for Evaluating Spine Treatments clinical trial: a sequential multiple assignment randomized trial for chronic low back painOpen Access.
Objective Chronic 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. Methods The Biomarkers for Evaluating Spine Treatments (BEST)...
| Publicado en: | Pain Medicine Vol. 26; no. 11; pp. 758 - 773 |
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| Autores principales: | , , , , , , , , , , , , , , , , , , , |
| Formato: | pictorial research tables/charts Journal Article |
| Publicado: |
Oxford University Press / USA
Nov2025
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=189108457&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 189108457 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 15262375 FRX jtl: Pain Medicine issn: 15262375 maglogo: N pubinfo: dt: Nov2025 vid: 26 iid: 11 pid: 10398 pub: Oxford University Press / USA artinfo: ui: 189108457 189108457 189108457 10.1093/pm/pnaf073 189108457 ppf: 758 ppct: 15 formats: tig: atl: Baseline characteristics of participants in the Biomarkers for Evaluating Spine Treatments clinical trial: a sequential multiple assignment randomized trial for chronic low back painOpen Access. aug: au: Rowland, Bryce Barth, Kelly S Bell, Kevin M Brooks, Amber K Chadwick, Andrea L Cleven, Annika Hurley, Robert W Mackey, Sean Patel, Kushang V Piva, Sara R Schneider, Michael J Al-Kadhi, Fatima Asante-Nketiah, Bernice Bagaason, Sarah Batorsky, Anna Borckardt, Jeffrey J Bowden, Anton E Carey, Timothy S Castellanos, Joel Chen, Lucy affil: Collaborative 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 sug: subj: Low Back Pain Therapy Chronic Pain Therapy Biological Markers Pain Management Methods Randomized Controlled Trials Research Subjects Psychosocial Factors Individualized Medicine Funding Source Human Male Female Adult Middle Age Aged Phenotype Scales Questionnaires Clinical Assessment Tools Random Forest Duloxetine Hydrochloride Therapeutic Use Bipolar Disorder Mania Suicide, Attempted Adverse Drug Event Serotonin Uptake Inhibitors Manual Therapy Therapeutic Exercise Dyspnea Chest Pain Diastolic Pressure Psychotherapy Research Subject Recruitment Adult: 19-44 years Middle Aged: 45-64 years Aged: 65+ years Male Female ab: Objective Chronic 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. Methods The 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. Results We 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. Conclusions The 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). pubtype: Academic Journal doctype: pictorial research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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