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Contemp Clin Trials. 2019 May 25. pii: S1551-7144(19)30032-1. doi: 10.1016/j.cct.2019.05.010. [Epub ahead of print]

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).

Author information

1
School of Health and Rehabilitation Sciences, University of Pittsburgh, 4028 Forbes Tower, Pittsburgh, PA 15260, USA. Electronic address: delitto@pitt.edu.
2
Department of Physical Therapy, University of Pittsburgh, 100 Technology Drive, Suite 210, Pittsburgh, PA 15219, USA.
3
Intermountain Healthcare, The Orthopaedic Specialty Hospital, 5848 South 300 East, Murray, UT 84107, USA.
4
Department of Physical Medicine and Rehabilitation, The Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.
5
Division of Physical Therapy, College of Health Professions, Medical University of South Carolina, Charleston, SC 29425, USA.
6
Department of Physical Therapy, College of Public Health & Health Professions, University of Florida, Box 100154, UFHSC, Gainesville, FL 32610, USA.
7
Wolff Center at UPMC, 4601 Baum Blvd, Suite 228, Pittsburgh, PA 15213, USA.
8
Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 2024 E Monument Street, Baltimore, MD 21287, USA.
9
Department of Healthcare Leadership and Management, Medical University of South Carolina, Charleston, SC 29425, USA.
10
Duke Clinical Research Institute and Department of Orthopaedic Surgery, Duke University School of Medicine, Durham, NC 27705, USA.
11
Johns Hopkins Community Physicians, 6225 Smith Avenue, Baltimore, MD 21209, USA.
12
Boston Medical Center, Boston, MA 02118, USA.
13
Department of Psychiatry, University of Pittsburgh, 3811 O'Hara Street, Pittsburgh, PA 15213, USA.
14
Department of Biostatistics, University of Pittsburgh Graduate School of Public Health, 130 De Soto Street, Pittsburgh, PA 15261, USA.
15
Department of Physical Medicine and Rehabilitation, University of Pittsburgh, 3471 Fifth Avenue, Suite 1103, Pittsburgh, PA 15213, USA.
16
Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, 3550 Terrace Street, Pittsburgh, PA 15261, USA.
17
Boston Medical Center, 1 Boston Medical Center Place, Dowling 5 South, Boston, MA 02118, USA.
18
Department of Family Medicine, Boston Medical Center, 1 Boston Medical Center Place, Dowling 5 South, Boston, MA 02118, USA.

Abstract

BACKGROUND:

Low 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 DESIGN:

The 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.

DISCUSSION:

The 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 REGISTRATION:

ClinicalTrials.govNCT02647658 Registered Jan. 6, 2016.

KEYWORDS:

Low back pain; Pragmatic clinical trial; Primary care; Psychologically informed physical therapy; Quality improvement; STarT Back Tool

PMID:
31136834
DOI:
10.1016/j.cct.2019.05.010

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