PMID- 33313724 OWN - NLM STAT- MEDLINE DCOM- 20210514 LR - 20210701 IS - 1526-4637 (Electronic) IS - 1526-2375 (Print) IS - 1526-2375 (Linking) VI - 21 IP - Suppl 2 DP - 2020 Dec 12 TI - A Sequential Multiple-Assignment Randomized Trial (SMART) for Stepped Care Management of Low Back Pain in the Military Health System: A Trial Protocol. PG - S73-S82 LID - 10.1093/pm/pnaa338 [doi] AB - BACKGROUND: The Defense Health Agency has prioritized system-level pain management initiatives within the Military Health System (MHS), with low back pain as one of the key focus areas. A stepped care model focused on nonpharmacologic treatment to promote self-management is recommended. Implementation of stepped care is complicated by lack of information on the most effective nonpharmacologic strategies and how to sequence and tailor the various available options. The Sequential Multiple-Assignment Randomization Trial for Low Back Pain (SMART LBP) is a multisite pragmatic trial using a SMART design to assess the effectiveness of nonpharmacologic treatments for chronic low back pain. DESIGN: This SMART trial has two treatment phases. Participants from three military treatment facilities are randomized to 6 weeks of phase I treatment, receiving either physical therapy (PT) or Army Medicine's holistic Move2Health (M2H) program in a package specific to low back pain. Nonresponders to treatment in phase I are again randomized to phase II treatment of combined M2H + PT or mindfulness-based treatment using the Mindfulness-Oriented Recovery Enhancement (MORE) program. The primary outcome is the Patient-Reported Outcomes Measurement Information System pain interference computer-adapted test score. SUMMARY: This trial is part of an initiative funded by the National Institutes of Health, Veterans Affairs, and the Department of Defense to establish a national infrastructure for effective system-level management of chronic pain with a focus on nonpharmacologic treatments. The results of this study will provide important information on nonpharmacologic care for chronic LBP in the MHS embedded within a stepped care framework. CI - The Author(s) 2020. Published by Oxford University Press on behalf of the American Academy of Pain Medicine. This work is written by US Government employees and is in the public domain in the US. FAU - Fritz, Julie M AU - Fritz JM AD - University of Utah, Salt Lake City, Utah. FAU - Rhon, Daniel I AU - Rhon DI AD - Brooke Army Medical Center, San Antonio, Texas. AD - Uniformed Services University of the Health Sciences, Bethesda, Maryland. FAU - Teyhen, Deydre S AU - Teyhen DS AD - Walter Reed Army Institute of Research, Silvers Spring, Maryland. FAU - Kean, Jacob AU - Kean J AD - University of Utah, Salt Lake City, Utah. FAU - Vanneman, Megan E AU - Vanneman ME AD - University of Utah, Salt Lake City, Utah. FAU - Garland, Eric L AU - Garland EL AD - University of Utah, Salt Lake City, Utah. FAU - Lee, Ian E AU - Lee IE AD - Defense Health Management Systems, Falls Church, Virginia. FAU - Thorp, Richard E AU - Thorp RE AD - Directorate of Program Analysis and Evaluation, Office of the Army Surgeon General, Joint Base San Antonio Fort Sam Houston, San Antonio, Texas, USA. FAU - Greene, Tom H AU - Greene TH AD - University of Utah, Salt Lake City, Utah. LA - eng GR - U24 AT009769/AT/NCCIH NIH HHS/United States GR - UH3 AT009763/AT/NCCIH NIH HHS/United States GR - UG3 AT009763/AT/NCCIH NIH HHS/United States PT - Clinical Trial Protocol PT - Journal Article PT - Research Support, N.I.H., Extramural PL - England TA - Pain Med JT - Pain medicine (Malden, Mass.) JID - 100894201 SB - IM MH - *Chronic Pain/therapy MH - Humans MH - *Low Back Pain/therapy MH - *Military Health Services MH - *Mindfulness MH - Pain Management MH - Randomized Controlled Trials as Topic MH - Treatment Outcome PMC - PMC7734656 OTO - NOTNLM OT - back pain OT - chronic pain OT - health coaching OT - holistic health OT - military health system OT - mindfulness OT - physical therapy OT - pragmatic clinical trial EDAT- 2020/12/15 06:00 MHDA- 2021/05/15 06:00 PMCR- 2020/12/10 CRDT- 2020/12/14 11:02 PHST- 2020/12/14 11:02 [entrez] PHST- 2020/12/15 06:00 [pubmed] PHST- 2021/05/15 06:00 [medline] PHST- 2020/12/10 00:00 [pmc-release] AID - 6033496 [pii] AID - pnaa338 [pii] AID - 10.1093/pm/pnaa338 [doi] PST - ppublish SO - Pain Med. 2020 Dec 12;21(Suppl 2):S73-S82. doi: 10.1093/pm/pnaa338.