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

NCT ID: NCT02647658

Last Updated: 2020-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2019-06-30

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.

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GBC+PIPT

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

Group Type: EXPERIMENTAL

Guideline Based Care plus Psychologically Informed Physical Therapy

Intervention Type: 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

Guideline Based Care (GBC)

Group Type: ACTIVE_COMPARATOR

Guideline Based Care (GBC)

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Guideline Based Care (GBC)

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

Intervention Type: BEHAVIORAL

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Medical Center

OTHER

Sponsor Role: collaborator

Intermountain Health Care, Inc.

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Anthony Delitto

Professor and Dean, SHRS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anthony Delitto, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Robert Saper, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Intermountain Healthcare

Salt Lake City, Utah, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36534910 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35543647 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33870150 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33238964 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31136834 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31060589 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PCS-1402-10867

Identifier Type: -

Identifier Source: org_study_id