Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients (TARGET)

• ClinicalTrials.gov Identifier: NCT02647658
• Recruitment Status: Completed
• First Posted: January 6, 2016
• Results First Posted: February 10, 2020
• Last Update Posted: February 10, 2020
• Sponsor: University of Pittsburgh
• Collaborators: Boston Medical Center; Intermountain Health Care, Inc.; Johns Hopkins University; Medical University of South Carolina; Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): Anthony Delitto, University of Pittsburgh

Study Description

Brief Summary:

Low back pain (LBP) is a common problem among US adults. Initial episodes tend to be self-limited ("acute"), but some people can progress to a state of persistent pain. Often termed "chronic" LBP (cLBP), this condition can cause prolonged difficulty with most daily activities, including job performance. This study will compare two approaches for preventing patients with acute LBP (aLBP) from developing cLBP using a pragmatic, cluster randomized trial. The first approach is to provide PCPs with information regarding a patient's risk of transitioning from aLBP to cLBP and to encourage PCPs to treat patients according to accepted clinical guidelines. The second approach is to provide the same risk information and have PCPs team up with physical therapists to deliver psychologically-informed physical therapy (PIPT) for those patients determined to be at high risk for transitioning to cLBP. The 1,860 patients expected to be enrolled at five regional sites (Pittsburgh, Pennsylvania; Boston, Massachusetts; Baltimore, Maryland; Charleston, South Carolina; and Salt Lake City, Utah) will start the study when their LBP is in an acute phase. The study's primary aims are to compare the proportions of cLBP and measures of functional ability between the two groups at 6 months. Secondary aims are to measure the referrals to physical therapists and specialists, opioid prescriptions, LBP-related x-rays or MRIs, surgeries, and other medical procedures during a 12-month follow-up period.

Condition or disease	Intervention/treatment	Phase
Low Back Pain	Behavioral: Guideline Based Care plus Psychologically Informed Physical Therapy; Behavioral: Guideline Based Care (GBC)	Not Applicable

Detailed Description:

Low back pain (LBP) is a common problem among US adults. Initial episodes tend to be self-limited ("acute"), but some people can progress to a state of persistent pain. Often termed "chronic" LBP (cLBP), this condition can cause prolonged difficulty with most daily activities, including job performance. Most patients see chiropractors or primary care physicians (PCPs) for initial episodes of LBP. This study will compare two approaches for preventing patients with acute LBP (aLBP) from developing cLBP using a cluster randomized trial. Both treatments can be delivered in an outpatient PCP setting. The first approach is to provide PCPs with information regarding a patient's risk of transitioning from aLBP to cLBP and to encourage PCPs to treat patients according to accepted clinical guidelines (Guideline Based Care, GBC). The second approach is to provide the same risk information and have PCPs team up with physical therapists to deliver psychologically-informed physical therapy (PIPT) for those patients determined to be at high risk for transitioning to cLBP (GBC+PIPT). PIPT is designed to help patients identify and overcome physical and psychological barriers to recovery. The 1,860 patients expected to be enrolled as part of quality improvement at five regional sites (Pittsburgh, Pennsylvania; Boston, Massachusetts; Baltimore, Maryland; Charleston, South Carolina; and Salt Lake City, Utah) will start the study when their LBP is in an acute phase. The study's primary aims are to compare the proportions of cLBP and measures of functional ability between the two groups at 6 months. Secondary aims are to measure the referrals to physical therapists and specialists, opioid prescriptions, LBP-related x-rays or MRIs, surgeries, and other medical procedures during a 12-month follow-up period. This study was designed with input from a variety of national and local stakeholders, including patients with LBP, providers, payers, professional organizations, purchasers, and policy representatives.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel assignment of clusters (clinics). Cluster randomized trial.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients: A Multi-Site Pragmatic Cluster Randomized Controlled Trial
• Study Start Date: March 2016
• Actual Primary Completion Date: March 1, 2019
• Actual Study Completion Date: June 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: GBC+PIPT; Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)	Behavioral: Guideline Based Care plus Psychologically Informed Physical Therapy; PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement
Active Comparator: GBC; Guideline Based Care (GBC)	Behavioral: Guideline Based Care (GBC); Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives

Outcome Measures

Primary Outcome Measures :

1. Number of Patients Who Reported Transition From Acute to Chronic Low Back Pain (cLBP) [ Time Frame: 6 months from baseline ]
   Measured using a 2-item Chronic Low Back Pain (LBP) questionnaire. Patient endorses low back pain that interferes with regular daily activities more than 3 months and more then 1/2 the days in the past 6 months.
2. Functional Disability [ Time Frame: 6 months ]

   Measured using the 10-item Oswestry Disability Index (version 2.1a). Also known as the Oswestry Low Back Pain Disability Questionnaire.

   A measure of a patient's functional disability. The scale ranges from 0% to 100% with higher scores indicating more disability.

Secondary Outcome Measures :

1. Number of Patients Referred to Physical Therapy [ Time Frame: 12 months ]
   Patient referred to physical therapy or psychologically informed physical therapy measured using electronic health records over 12 months.
2. Number of Patients Prescribed Opioids [ Time Frame: 12 months ]
   Medication prescription for opioids measured using electronic health records over 12 months.
3. Number of Patients With Orders for Diagnostic Imaging Tests [ Time Frame: 12 months ]
   Referrals for diagnostic imaging (X-rays and MRI) measured using electronic health records
4. Number of Patients Referred to Other Rehabilitation or Pain Management Specialist [ Time Frame: 12 months ]
   Referral to any non-physical therapy rehabilitation or pain management specialist (chiropractic, physiatrist, pain management) measured using electronic health records
5. Number of Patients Referred to Surgery Specialist [ Time Frame: 12 months ]
   Referral to any surgical specialist (orthopaedist, neurosurgeon, anesthesiologist) measured using electronic health records
6. Number of Patients Undergoing Interventional Pain Procedures [ Time Frame: 12 months ]
   Receipt of interventional pain procedures including epidural steroid injections measured using electronic health records
7. Number of Patients Who Had Back Surgery [ Time Frame: 12 months ]
   Documentation that patient underwent back surgery in electronic health records

Other Outcome Measures:

1. Number of Patients Prescribed Opioids [ Time Frame: Up to 21 days after initial visit for acute low back pain ]
   Medication prescription for opioids measured using electronic health records at the index baseline visit for the patient. Measure of intervention fidelity post clinic randomization.
2. Number of Patients Referred to Physical Therapy [ Time Frame: Up to 21 days after initial visit for acute low back pain ]
   Patient referred to physical therapy or psychologically informed physical therapy measured using electronic health records at the index baseline visit. This is a measure of intervention fidelity post-randomization of the clinics.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 18 years of age or older
• Receiving care for acute low back pain during a primary care clinic visit
• Able to provide informed consent

Exclusion Criteria:

• Medical contraindications to physical therapy based on the judgment of the primary care provider as documented in the medical record (i.e., "red flag" signs and symptoms of a potentially serious condition such as cauda equina syndrome, major or rapidly progressing neurological deficit, cancer, spinal infection or fracture)

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins University

Baltimore, Maryland, United States, 21287

United States, Massachusetts

Boston Medical Center

Boston, Massachusetts, United States, 02118

United States, Pennsylvania

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15213

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

United States, Utah

Intermountain Healthcare

Salt Lake City, Utah, United States, 84111

Sponsors and Collaborators

University of Pittsburgh

Boston Medical Center

Intermountain Health Care, Inc.

Johns Hopkins University

Medical University of South Carolina

Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Anthony Delitto, PT, PhD; University of Pittsburgh
• Principal Investigator: Robert Saper, MD, MPH; Boston Medical Center

  Study Documents (Full-Text)

Documents provided by Anthony Delitto, University of Pittsburgh:

Study Protocol and Statistical Analysis Plan  [PDF] September 1, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Delitto A, Patterson CG, Stevans JM, Freburger JK, Khoja SS, Schneider MJ, Greco CM, Freel JA, Sowa GA, Wasan AD, Brennan GP, Hunter SJ, Minick KI, Wegener ST, Ephraim PL, Beneciuk JM, George SZ, Saper RB. Stratified care to prevent chronic low back pain in high-risk patients: The TARGET trial. A multi-site pragmatic cluster randomized trial. EClinicalMedicine. 2021 Mar 30;34:100795. doi: 10.1016/j.eclinm.2021.100795. eCollection 2021 Apr.

Middleton A, Fitzgerald GK, Delitto A, Saper RB, Gergen Barnett K, Stevans J. Implementing stratified care for acute low back pain in primary care using the STarT Back instrument: a process evaluation within the context of a large pragmatic cluster randomized trial. BMC Musculoskelet Disord. 2020 Nov 25;21(1):776. doi: 10.1186/s12891-020-03800-6.

Delitto A, Patterson CG, Stevans JM, Brennan GP, Wegener ST, Morrisette DC, Beneciuk JM, Freel JA, Minick KI, Hunter SJ, Ephraim PL, Friedman M, Simpson KN, George SZ, Daley KN, Albert MC, Tamasy M, Cash J, Lake DS, Freburger JK, Greco CM, Hough LJ, Jeong JH, Khoja SS, Schneider MJ, Sowa GA, Spigle WA, Wasan AD, Adams WG, Lemaster CM, Mishuris RG, Plumb DL, Williams CT, Saper RB. 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). Contemp Clin Trials. 2019 Jul;82:66-76. doi: 10.1016/j.cct.2019.05.010. Epub 2019 May 25.

Beneciuk JM, George SZ, Greco CM, Schneider MJ, Wegener ST, Saper RB, Delitto A. Targeted interventions to prevent transitioning from acute to chronic low back pain in high-risk patients: development and delivery of a pragmatic training course of psychologically informed physical therapy for the TARGET trial. Trials. 2019 May 6;20(1):256. doi: 10.1186/s13063-019-3350-3.

• Responsible Party: Anthony Delitto, Professor and Dean, SHRS, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT02647658
• Other Study ID Numbers: PCS-1402-10867
• First Posted: January 6, 2016
• Results First Posted: February 10, 2020
• Last Update Posted: February 10, 2020
• Last Verified: February 2020

Keywords provided by Anthony Delitto, University of Pittsburgh:

acute low back pain; primary care; psychologically informed physical therapy; cluster randomized pragmatic trial; comparative effectiveness; secondary prevention

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations