Optimizing treatment protocols for spinal manipulative therapy: study protocol for a randomized trial

Julie M Fritz, Jason A Sharpe, Elizabeth Lane, Doug Santillo, Tom Greene, Gregory Kawchuk, Julie M Fritz, Jason A Sharpe, Elizabeth Lane, Doug Santillo, Tom Greene, Gregory Kawchuk

Abstract

Background: Low 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.

Methods: A 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.

Discussion: Building 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 registration: ClinicalTrials.gov, NCT02868034 . Registered on 16 August 2016.

Keywords: Factorial design; Low back pain; Multiphase optimization; Spinal manipulative therapy.

Conflict of interest statement

Ethics approval and consent to participate

Ethics approval has been received from the University of Utah (IRB_00092127) and University of Alberta (Pro00067152) Institutional Review Boards. Informed consent will be obtained from all participants in the study.

Consent for publication

The individuals appearing in Figs. 4 and 5 have agreed to publication of these figures with identifiable information.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Conceptual model of underlying mechanisms of SMT based on preliminary research [33]
Fig. 2
Fig. 2
Phases of Multiphase Optimization Strategy (MOST) as applied to development of optimized SMT research [40]
Fig. 3
Fig. 3
Study design showing three phases and four assessments. Each assessment includes PROs, spinal stiffness, and multifidus activation measures
Fig. 4
Fig. 4
The Vertetrack device positioned over a participant to assess spinal stiffness
Fig. 5
Fig. 5
The preferred SMT technique to be used in this study
Fig. 6
Fig. 6
Study schedule based on the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines

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