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BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2020

Open Access 01-12-2020 | Physical Therapy | Study protocol

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

Authors: Richard L. Skolasky, Stephen T. Wegener, Rachel V. Aaron, Patti Ephraim, Gerard Brennan, Tom Greene, Elizabeth Lane, Kate Minick, Adam W. Hanley, Eric L. Garland, Julie M. Fritz

Published in: BMC Musculoskeletal Disorders | Issue 1/2020

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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).
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Metadata
Title
The OPTIMIZE study: protocol of a pragmatic sequential multiple assessment randomized trial of nonpharmacologic treatment for chronic, nonspecific low back pain
Authors
Richard L. Skolasky
Stephen T. Wegener
Rachel V. Aaron
Patti Ephraim
Gerard Brennan
Tom Greene
Elizabeth Lane
Kate Minick
Adam W. Hanley
Eric L. Garland
Julie M. Fritz
Publication date
01-12-2020
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2020
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/s12891-020-03324-z

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