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

NCT02647658 | Completed Results

• 1 other identifier: PCS-1402-10867
• Study Type: interventional
• Target: 2,300
• Locations: 1 country
• Sites: 5

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.

Conditions

Low Back Pain

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Number of Patients Who Reported Transition From Acute to Chronic Low Back Pain (cLBP)

  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.

  6 months from baseline

• Functional Disability

  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.

  6 months

Secondary Outcomes (7)

• Number of Patients Referred to Physical Therapy

  12 months

• Number of Patients Prescribed Opioids

  12 months

• Number of Patients With Orders for Diagnostic Imaging Tests

  12 months

• Number of Patients Referred to Other Rehabilitation or Pain Management Specialist

  12 months

• Number of Patients Referred to Surgery Specialist

  12 months

Other Outcomes (2)

• Number of Patients Prescribed Opioids

  Up to 21 days after initial visit for acute low back pain

• Number of Patients Referred to Physical Therapy

  Up to 21 days after initial visit for acute low back pain

Study Arms (2)

GBC+PIPT

EXPERIMENTAL

Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)

Behavioral: Guideline Based Care plus Psychologically Informed Physical Therapy

GBC

ACTIVE COMPARATOR

Guideline Based Care (GBC)

Behavioral: Guideline Based Care (GBC)

Interventions

Guideline Based Care plus Psychologically Informed Physical Therapy BEHAVIORAL

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

GBC+PIPT

Guideline Based Care (GBC) BEHAVIORAL

Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives

GBC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pittsburgh: lead
• Boston Medical Center: collaborator
• Intermountain Health Care, Inc.: collaborator
• Johns Hopkins University: collaborator
• Medical University of South Carolina: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (5)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Intermountain Healthcare

Salt Lake City, Utah, 84111, United States

Location

Related Publications (6)

• Roseen EJ, Smith CN, Essien UR, Cozier YC, Joyce C, Morone NE, Phillips RS, Gergen Barnett K, Patterson CG, Wegener ST, Brennan GP, Delitto A, Saper RB, Beneciuk JM, Stevans JM. Racial and Ethnic Disparities in the Incidence of High-Impact Chronic Pain Among Primary Care Patients with Acute Low Back Pain: A Cohort Study. Pain Med. 2023 Jun 1;24(6):633-643. doi: 10.1093/pm/pnac193.

  PMID: 36534910 DERIVED

• Beneciuk JM, George SZ, Patterson CG, Smith CN, Brennan GP, Wegener ST, Roseen EJ, Saper RB, Delitto A. Treatment effect modifiers for individuals with acute low back pain: secondary analysis of the TARGET trial. Pain. 2023 Jan 1;164(1):171-179. doi: 10.1097/j.pain.0000000000002679. Epub 2022 May 9.

  PMID: 35543647 DERIVED

• 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.

  PMID: 33870150 DERIVED

• 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.

  PMID: 33238964 DERIVED

• 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.

  PMID: 31136834 DERIVED

• 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.

  PMID: 31060589 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Charity Patterson
• Organization: University of Pittsburgh

cgp22@pitt.edu

412-383-4812

Study Officials

• Anthony Delitto, PT, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Robert Saper, MD, MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Dean, SHRS

Model Details: Parallel assignment of clusters (clinics). Cluster randomized trial.

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 6, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: June 30, 2019
• Last Updated: February 10, 2020
• Results First Posted: February 10, 2020

Record last verified: 2020-02

Locations

US (5)