Evidence map›Paper›PMID 29866131›Full record

ArticleTrials2018

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

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02868034 (Optimization of Spinal Manipulation Therapy), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02868034 phase2completednot on this map

Optimization of Spinal Manipulation Therapy (SMT) Protocols

TypeinterventionalSponsorUniversity of UtahRan2017 to 2019Enrolled273ConditionsLow Back PainArmsSMT, Mobilizing Exercises, Activation Exercises, SMT extended
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
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  3. Psychometric examination of short forms from the University of Washington pain-related self-efficacy and concerns about pain item banks in patients with low back pain.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2022
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  5. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 2 countries.

Julie M FritzCollege of Health, University of Utah, 520 Wakara Way, Salt Lake City, UT, 84108, USA. julie.fritz@utah.edu.ORCID http://orcid.org/0000-0002-3599-1057
Jason A SharpeDepartment of Physical Therapy & Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT, 84108, USA.
Elizabeth LaneDepartment of Physical Therapy & Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT, 84108, USA.
Doug SantilloDepartment of Physical Therapy & Athletic Training, University of Utah, 520 Wakara Way, Salt Lake City, UT, 84108, USA.
Tom GreeneDepartment of Internal Medicine and Director, Population Health Research Study Design and Biostatistics Center, School of Medicine, University of Utah, 295 Chipeta Way, Salt Lake City, UT, 84132, USA.
Gregory KawchukDepartment of Physical Therapy, Faculty of Rehabilitation Medicine, University of Alberta, 3-44 Corbett Hall, Edmonton, AB, T6G 2G4, Canada.
University of Utah · USUniversity of Alberta · CA

Funding

University of Utah Center for Clinical and Translational ScienceUL1TR001067 · NCATS · UNIVERSITY OF UTAH · PI DERE, WILLARD H., HESS, RACHEL · 2013 to 2017
$19.8M
UNIVERSITY OF UTAH CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCE-UL1: BPCAUL1RR025764 · NCRR · UNIVERSITY OF UTAH · PI MCCLAIN, DONALD A. · 2008 to 2011
$19.4M
University of Utah Center for Clinical and Translational Science-UL1UL1TR000105 · NCATS · UNIVERSITY OF UTAH · PI MCCLAIN, DONALD A. · 2012 to 2013
$5.1M
Optimization of Spinal Manipulative Therapy (SMT) ProtocolsUH3AT009293 · NCCIH · UNIVERSITY OF UTAH · PI FRITZ, JULIE M · 2016 to 2018
$1.4M
National Center for Advancing Translational Sciences UL1RR025764National Center for Complementary and Integrative Health UH3AT009293NCATS NIH HHS UL1 TR000105NCATS NIH HHS UL1 TR001067NCCIH NIH HHS UH3 AT009293NCRR NIH HHS UL1 RR025764
6 · The paper itself

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. 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 registrationClinicalTrials.gov, NCT02868034 . Registered on 16 August 2016.

Indexed as

AdolescentAdultBiomechanical PhenomenaDisability EvaluationFemaleHumansLow Back PainMaleManipulation, SpinalMiddle AgedPain MeasurementRandomized Controlled Trials as TopicRecovery of FunctionSpineTime FactorsTreatment OutcomeFactorial designLow back painMultiphase optimizationSpinal manipulative therapy

Identifiers

PMID29866131
PMCPMC5987587
OpenAlexW2807669261

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.