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

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

Interventions

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

BEHAVIORAL

Guideline Based Care (GBC)

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

Sponsors & Collaborators

• Boston Medical Center

  collaborator OTHER

• Intermountain Health Care, Inc.

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• University of Pittsburgh

  lead OTHER

Principal Investigators

• Anthony Delitto, PT, PhD · University of Pittsburgh

• Robert Saper, MD, MPH · Boston Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-03-31

Primary Completion

2019-03-01

Completion

2019-06-30

Countries

• United States

Study Locations