PMID- 32393216 OWN - NLM STAT- MEDLINE DCOM- 20210201 LR - 20230224 IS - 1471-2474 (Electronic) IS - 1471-2474 (Linking) VI - 21 IP - 1 DP - 2020 May 11 TI - The OPTIMIZE study: protocol of a pragmatic sequential multiple assessment randomized trial of nonpharmacologic treatment for chronic, nonspecific low back pain. PG - 293 LID - 10.1186/s12891-020-03324-z [doi] LID - 293 AB - BACKGROUND: Low back pain is a prevalent condition that causes a substantial health burden. Despite intensive and expensive clinical efforts, its prevalence is growing. Nonpharmacologic treatments are effective at improving pain-related outcomes; however, treatment effect sizes are often modest. Physical therapy (PT) and cognitive behavioral therapy (CBT) have the most consistent evidence of effectiveness. Growing evidence also supports mindfulness-based approaches. Discussions with providers and patients highlight the importance of discussing and trying options to find the treatment that works for them and determining what to do when initial treatment is not successful. Herein, we present the protocol for a study that will evaluate evidence-based, protocol-driven treatments using PT, CBT, or mindfulness to examine comparative effectiveness and optimal sequencing for patients with chronic low back pain. METHODS: The Optimized Multidisciplinary Treatment Programs for Nonspecific Chronic Low Back Pain (OPTIMIZE) Study will be a multisite, comparative effectiveness trial using a sequential multiple assessment randomized trial design enrolling 945 individuals with chronic low back pain. The co-primary outcomes will be disability (measured using the Oswestry Disability Index) and pain intensity (measured using the Numerical Pain Rating Scale). After baseline assessment, participants will be randomly assigned to PT or CBT. At week 10, participants who have not experienced at least 50% improvement in disability will be randomized to cross-over phase-1 treatments (e.g., PT to CBT) or to Mindfulness-Oriented Recovery Enhancement (MORE). Treatment will consist of 8 weekly sessions. Long-term outcome assessments will be performed at weeks 26 and 52. DISCUSSION: Results of this study may inform referring providers and patients about the most effective nonoperative treatment and/or sequence of nonoperative treatments to treat chronic low back pain. TRIAL REGISTRATION: This study was prospectively registered on March 1, 2019, with Clinicaltrials.gov under the registration number NCT03859713 (https://clinicaltrials.gov/ct2/show/NCT03859713). FAU - Skolasky, Richard L AU - Skolasky RL AD - Department of Orthopaedic Surgery, The Johns Hopkins University School of Medicine, 601 N. Caroline St, Baltimore, MD, 21287, USA. rskolas1@jhmi.edu. AD - Department of Physical Medicine and Rehabilitation, The Johns Hopkins University School of Medicine, 601 N. Caroline St, Baltimore, MD, 21287, USA. rskolas1@jhmi.edu. FAU - Wegener, Stephen T AU - Wegener ST AD - Department of Physical Medicine and Rehabilitation, The Johns Hopkins University School of Medicine, 601 N. Caroline St, Baltimore, MD, 21287, USA. FAU - Aaron, Rachel V AU - Aaron RV AD - Department of Physical Medicine and Rehabilitation, The Johns Hopkins University School of Medicine, 601 N. Caroline St, Baltimore, MD, 21287, USA. FAU - Ephraim, Patti AU - Ephraim P AD - Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe St, Baltimore, MD, 21205, USA. FAU - Brennan, Gerard AU - Brennan G AD - Intermountain Healthcare, 36 S State St, Salt Lake City, UT, 84111, USA. FAU - Greene, Tom AU - Greene T AD - Department of Population Health Sciences, University of Utah, 201 Presidents' Cir, Salt Lake City, UT, 84112, USA. FAU - Lane, Elizabeth AU - Lane E AD - Department of Physical Therapy and Athletic Training, University of Utah, 201 Presidents' Cir, Salt Lake City, UT, 84112, USA. FAU - Minick, Kate AU - Minick K AD - Intermountain Healthcare, 36 S State St, Salt Lake City, UT, 84111, USA. FAU - Hanley, Adam W AU - Hanley AW AD - College of Social Work, University of Utah, 201 Presidents' Cir, Salt Lake City, UT, 84112, USA. FAU - Garland, Eric L AU - Garland EL AD - College of Social Work, University of Utah, 201 Presidents' Cir, Salt Lake City, UT, 84112, USA. FAU - Fritz, Julie M AU - Fritz JM AD - Department of Physical Therapy and Athletic Training, University of Utah, 201 Presidents' Cir, Salt Lake City, UT, 84112, USA. LA - eng SI - ClinicalTrials.gov/NCT03859713 GR - UL1 TR002538/TR/NCATS NIH HHS/United States GR - OTS-LBP-2017C1-6486/PCORI/Patient-Centered Outcomes Research Institute/United States PT - Clinical Trial Protocol PT - Journal Article DEP - 20200511 PL - England TA - BMC Musculoskelet Disord JT - BMC musculoskeletal disorders JID - 100968565 SB - IM MH - Adolescent MH - Adult MH - Chronic Pain/*therapy MH - Exercise Therapy/*methods MH - Female MH - Follow-Up Studies MH - Humans MH - Low Back Pain/*therapy MH - Male MH - Middle Aged MH - Mindfulness/*methods MH - Multicenter Studies as Topic MH - Musculoskeletal Manipulations/*methods MH - Pain Measurement MH - Patient Acceptance of Health Care MH - Patient Reported Outcome Measures MH - Pragmatic Clinical Trials as Topic MH - Self Report MH - Treatment Outcome MH - Young Adult PMC - PMC7216637 OTO - NOTNLM OT - Cognitive behavioral therapy OT - Comparative effectiveness research OT - Low back pain OT - Mindfulness OT - Physical therapy COIS- The authors declare that they have no competing interests. EDAT- 2020/05/13 06:00 MHDA- 2021/02/02 06:00 PMCR- 2020/05/11 CRDT- 2020/05/13 06:00 PHST- 2020/03/17 00:00 [received] PHST- 2020/04/30 00:00 [accepted] PHST- 2020/05/13 06:00 [entrez] PHST- 2020/05/13 06:00 [pubmed] PHST- 2021/02/02 06:00 [medline] PHST- 2020/05/11 00:00 [pmc-release] AID - 10.1186/s12891-020-03324-z [pii] AID - 3324 [pii] AID - 10.1186/s12891-020-03324-z [doi] PST - epublish SO - BMC Musculoskelet Disord. 2020 May 11;21(1):293. doi: 10.1186/s12891-020-03324-z.