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The OPTIMIZE study: protocol of a pragmatic sequential multiple assessment randomized trial of nonpharmacologic treatment for chronic, nonspecific low back pain.

ABSTRACT: 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).

SUBMITTER: Skolasky RL

PROVIDER: S-EPMC7216637 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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The OPTIMIZE study: protocol of a pragmatic sequential multiple assessment randomized trial of nonpharmacologic treatment for chronic, nonspecific low back pain.

Skolasky Richard L RL Wegener Stephen T ST Aaron Rachel V RV Ephraim Patti P Brennan Gerard G Greene Tom T Lane Elizabeth E Minick Kate K Hanley Adam W AW Garland Eric L EL Fritz Julie M JM

BMC musculoskeletal disorders 20200511 1

<h4>Background</h4>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 provi ...[more]

PMID: 32393216

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Project description:Background:Researchers are highly interested in the study of nonspecific low back pain (NSLBP). However, few have attempted to collect global data, analyze the emerging trends, and conduct reviews from the perspectives of visualization and bibliometrics. Purpose:We aimed to evaluate research situation and capture subsequent developmental dynamics regarding NSLBP via CiteSpace. Methods:Publications on NSLBP in recent 19 years were retrieved from the Web of Science Core Collection (WoSCC). We used CiteSpace to analyze publication outputs, document types, countries, institutions, journals, authors, references, and keywords. Knowledge foundation, hot topics, and future direction were then stated. Results:A total of 1099 papers were collected, and the trend of annual publications maintained growth with small fluctuations. Australia (188) and the University of Sydney (76) were the most prolific country and institution, respectively. The Netherlands (0.84) and the University of Sydney (0.47) had the maximum centrality, thus indicating that they have importance in this field. The journal Spine (publication: 87, cocitation counts: 942) ranked first in terms of the volume of publications and cocitation counts. Maher CG (52) who published the most papers and Waddell G (286) who was cited most frequently were the leading authors, thus making strong academic influences. "Motor control exercise" was the largest cluster, which contained most related research articles. 14 references with the strongest citation counts were cited until 2018, thus implying the future development trend. Current hotspots were treatment, meta-analysis, method, and risk factors. Spine, efficacy, adult, and meta-analysis can be regarded as research frontiers. Conclusion:This study offers insights into the trend of NSLBP to determine major research countries and institutions, core journals, pivotal authors, overall development tendency, hot topics, and research frontiers. Moreover, it will help researchers extract hidden valuable information for further study.

Project description:ImportanceDespite epidemic rates of addiction and death from prescription opioids in the United States, suggesting the importance of providing alternatives to opioids in the treatment of pain, little is known regarding how payers' coverage policies may facilitate or impede access to such treatments.ObjectiveTo examine coverage policies for 5 nonpharmacologic approaches commonly used to treat acute or chronic low back pain among commercial and Medicare Advantage insurance plans, plus an additional 6 treatments among Medicaid plans.Design, setting, and participantsCross-sectional study of 15 commercial, 15 Medicaid, and 15 Medicare Advantage health plans for the 2017 calendar year in 16 states representing more than half of the US population. Interviews were conducted with 43 senior medical and pharmacy health plan executives from representative plans.Main outcomes and measuresMedical necessity and coverage status for the treatments examined, as well as the use of utilization management tools and cost-sharing magnitude and structure.ResultsCommercial and Medicare insurers consistently regarded physical and occupational therapy as medically necessary, but policies varied for other therapies examined. Payers most commonly covered physical therapy (98% [44 of 45 plans]), occupational therapy (96% [43 of 45 plans]), and chiropractic care (89% [40 of 45 plans]), while transcutaneous electrical nerve stimulation (67% [10 of 15 plans]) and steroid injections (60% [9 of 15 plans]) were the most commonly covered among the therapies examined for Medicaid plans only. Despite evidence in the literature to support use of acupuncture and psychological interventions, these therapies were either not covered by plans examined (67% of all plans [30 of 45] did not cover acupuncture) or lacked information about coverage (80% of Medicaid plans [12 of 15] lacked information about coverage of psychological interventions). Utilization management tools, such as prior authorization, were common, but criteria varied greatly with respect to which conditions and what quantity and duration of services were covered. Interviewees represented 6 Medicaid managed care organizations, 2 Medicare Advantage or Part D plans, 9 commercial plans, and 3 trade organizations (eg, Blue Cross Blue Shield Association). Interviews with plan executives indicated a low level of integration between the coverage decision-making processes for pharmacologic and nonpharmacologic therapies for chronic pain.Conclusions and relevanceWide variation in coverage of nonpharmacologic treatments for low back pain may be driven by the absence of best practices, the administrative complexities of developing and revising coverage policies, and payers' economic incentives. Such variation suggests an important opportunity to improve the accessibility of services, reduce opioid use, and ultimately improve the quality of care for individuals with chronic, noncancer pain while alleviating the burden of opioid addiction and overdose.

Dataset Information

The OPTIMIZE study: protocol of a pragmatic sequential multiple assessment randomized trial of nonpharmacologic treatment for chronic, nonspecific low back pain.

Publications

The OPTIMIZE study: protocol of a pragmatic sequential multiple assessment randomized trial of nonpharmacologic treatment for chronic, nonspecific low back pain.

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