Abstract
BackgroundLow back pain is a common and costly condition. Spinal manipulative therapy (SMT) is a treatment supported in some guidelines, although most clinical trials examining SMT report small effect sizes. Enhancing the effects of SMT requires an understanding of underlying mechanisms and a systematic approach to leverage understanding of mechanisms to create more effective treatment protocols that are scalable in clinical practice. Prior work has identified effects on spinal stiffness and lumbar multifidus activation as possible mechanisms. This project represents a refinement phase study within the context of a multi-phase optimization strategy (MOST) framework. Our goal is to identify an optimized SMT treatment protocol by examining the impact of using co-intervention exercise strategies that are proposed to accentuate SMT mechanisms. The optimized protocol can then be evaluated in confirmation phase clinical trials and implementation studies.MethodsA phased, factorial randomized trial design will be used to evaluate the effects of three intervention components provided in eight combinations on mechanistic (spinal stiffness and multifidus muscle activation) and patient-reported outcomes (pain and disability). All participants will receive two sessions then will be randomly assigned to receive six additional sessions (or no additional treatment) over the next three weeks with factorial combinations of additional SMT and exercise co-interventions (spine mobilizing and multifidus activating). Outcome assessments occur at baseline, and one week, four weeks, and three months after enrollment. Pre-specified analyses will evaluate main effects for treatment components as well as interaction effects.DiscussionBuilding on preliminary findings identifying possible mechanisms of effects for SMT, this trial represents the next phase in a multiphase strategy towards the ultimate goal of developing an optimized protocol for providing SMT to patients with LBP. If successful, the results of this trial can be tested in future clinical trials in an effort to produce larger treatment benefits and improve patient-centered outcomes for individuals with LBP.Trial registrationClinicalTrials.gov, NCT02868034. Registered on 16 August 2016.
Highlights
Low back pain is a common and costly condition
While Spinal manipulative therapy (SMT) is recommended in many guidelines, effect sizes for SMT are modest for patient-centered outcomes of pain and disability [9,10,11], leading other reviews to conclude the benefits of SMT are not clinically meaningful [12, 13]
The primary aim of the current study is to evaluate these three SMT treatment components and their effect on SMT mechanistic outcomes and patient-centered clinical outcomes
Summary
Spinal manipulative therapy (SMT) is a treatment supported in some guidelines, most clinical trials examining SMT report small effect sizes. Prior work has identified effects on spinal stiffness and lumbar multifidus activation as possible mechanisms. This project represents a refinement phase study within the context of a multi-phase optimization strategy (MOST) framework. Our goal is to identify an optimized SMT treatment protocol by examining the impact of using co-intervention exercise strategies that are proposed to accentuate SMT mechanisms. Practice guidelines and systematic reviews identify several non-pharmacologic LBP treatments with some evidence of benefit often including spinal manipulative. The optimal protocol for providing SMT treatment is currently not established
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