Highlights
- •Research has typically studied SMT as a unimodal treatment.
- •Clinicians usually provide SMT as part of a multimodal treatment package.
- •We used a factorial randomized trial to develop a multimodal SMT protocol.
- •Disability was improved by combining SMT and multifidus activating exercises.
- •Future research using optimized SMT protocols may increase treatment effects.
Abstract
Spinal manipulative therapy (SMT) is a common nonpharmacological treatment for low
back pain (LBP). Although generally supported by systematic reviews and practice guidelines,
clinical trials evaluating SMT have been characterized by small effect sizes. This
study adopts a Multiphase Optimization Strategy framework to examine individual components
of an SMT delivery protocol using a single-blind trial with the goal of identifying
and optimizing a multicomponent SMT protocol. We enrolled 241 participants with LBP.
All participants received 2 SMT treatment sessions in the first week then were randomly
assigned additional treatment based on a fully factorial design. The 3 randomized
treatment components provided in twice weekly sessions over 3 weeks were multifidus
activating exercise, spinal mobilizing exercise, and additional SMT dose. Primary
outcomes included clinical (Oswestry Disability Index, numeric pain intensity rating)
and mechanistic (spinal stiffness, multifidus muscle activation) measures assessed
at baseline, 1, 4, and 12 weeks. Significant differences were found for the Oswestry
index after 12 weeks for participants receiving multifidus activating exercise (mean
difference = −3.62, 97.5% CI: −6.89, −0.35; P= .01). There were no additional significant main or interaction effects for other
treatment components or different outcome measures. The optimized SMT protocol identified
in this study included SMT sessions followed by multifidus activating exercises.
Perspective
Optimizing the effects of nonpharmacological treatments such as SMT for LBP is challenging
due to uncertainty regarding mechanisms and the complexity of multicomponent protocols.
This factorial randomized trial examined SMT protocols provided with differing co-interventions
with mechanistic and patient-centered outcomes. Patient-centered outcomes were optimized
by inclusion of lumbar multifidus strengthening exercises.
Keywords
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Article info
Publication history
Published online: December 09, 2020
Accepted:
November 11,
2020
Received in revised form:
October 23,
2020
Received:
July 20,
2020
Footnotes
Research reported in this publication was supported by the National Center for Complementary and Integrative Health of the National Institutes of Health under award UH3AT009293-01). The study was supported by the University of Utah Study Design and Biostatistics Center with funding in part through grant 5UL1TR001067-02 (formerly 8UL1TR000105 and UL1RR025764) from the National Center for Research Resources and the National Center for Advancing Translational Sciences of the National Institutes of Health.
The authors report no conflicts of interest.
Identification
Copyright
Crown Copyright © 2020 Published by Elsevier Inc. on behalf of United States Association for the Study of Pain, Inc.
