-
Contemp Clin Trials · Jul 2019
Study protocol for targeted interventions to prevent chronic low back pain in high-risk patients: A multi-site pragmatic cluster randomized controlled trial (TARGET Trial).
- Anthony Delitto, Charity G Patterson, Joel M Stevans, Gerard P Brennan, Stephen T Wegener, David C Morrisette, Jason M Beneciuk, Jennifer A Freel, Kate I Minick, Stephen J Hunter, Patti L Ephraim, Michael Friedman, Kit N Simpson, Steven Z George, Kelly N Daley, Michael C Albert, Marie Tamasy, Jewel Cash, D Scott Lake, Janet K Freburger, Carol M Greco, Linda J Hough, Jong-Hyeon Jeong, Samannaaz S Khoja, Michael J Schneider, Gwendolyn A Sowa, Wendy A Spigle, Ajay D Wasan, William G Adams, Chelsey M Lemaster, Rebecca G Mishuris, Dorothy L Plumb, Charles T Williams, and Robert B Saper.
- School of Health and Rehabilitation Sciences (SHRS), University of Pittsburgh, 4028 Forbes Tower, Pittsburgh, PA 15260, USA. Electronic address: delitto@pitt.edu.
- Contemp Clin Trials. 2019 Jul 1; 82: 66-76.
BackgroundLow back pain (LBP) is one of the most prevalent and potentially disabling conditions for which people seek health care. Patients, providers, and payers agree that greater effort is needed to prevent acute LBP from transitioning to chronic LBP.Methods And Study DesignThe TARGET (Targeted Interventions to Prevent Chronic Low Back Pain in High-Risk Patients) Trial is a primary care-based, multisite, cluster randomized, pragmatic trial comparing guideline-based care (GBC) to GBC + referral to Psychologically Informed Physical Therapy (PIPT) for patients presenting with acute LBP and identified as high risk for persistent disabling symptoms. Study sites include primary care clinics within each of five geographical regions in the United States, with clinics randomized to either GBC or GBC + PIPT. Acute LBP patients at all clinics are risk stratified (high, medium, low) using the STarT Back Tool. The primary outcomes are the presence of chronic LBP and LBP-related functional disability determined by the Oswestry Disability Index at 6 months. Secondary outcomes are LBP-related processes of health care and utilization of services over 12 months, determined through electronic medical records. Study enrollment began in May 2016 and concluded in June 2018. The trial was powered to include at least 1860 high-risk patients in the randomized controlled trial cohort. A prospective observational cohort of approximately 6900 low and medium-risk acute LBP patients was enrolled concurrently.DiscussionThe TARGET pragmatic trial aims to establish the effectiveness of the stratified approach to acute LBP intervention targeting high-risk patients with GBC and PIPT.Trial RegistrationClinicalTrials.govNCT02647658 Registered Jan. 6, 2016.Copyright © 2019. Published by Elsevier Inc.
Notes
Knowledge, pearl, summary or comment to share?You can also include formatting, links, images and footnotes in your notes
- Simple formatting can be added to notes, such as
*italics*
,_underline_
or**bold**
. - Superscript can be denoted by
<sup>text</sup>
and subscript<sub>text</sub>
. - Numbered or bulleted lists can be created using either numbered lines
1. 2. 3.
, hyphens-
or asterisks*
. - Links can be included with:
[my link to pubmed](http://pubmed.com)
- Images can be included with:
![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
- For footnotes use
[^1](This is a footnote.)
inline. - Or use an inline reference
[^1]
to refer to a longer footnote elseweher in the document[^1]: This is a long footnote.
.