PI Anthony Delitto

Title Targeted interventions to Prevent Chronic Low Back Pain in High Risk Patients: A Multi-Site Pragmatic RCT

Description: Persistent low back pain (LBP), often termed “chronic low back pain,” can cause prolonged difficulty with most daily activities and can even cost some people their jobs. Most patients see chiropractors or primary care physicians (PCPs) for LBP. We will study the transition from acute LBP to chronic LBP and compare two treatments that can be delivered in an outpatient PCP setting. The first approach is to allow PCPs to do what they think is best, termed “usual care.” The second is to have PCPs team up with physical therapists and deliver cognitive behavioral therapy (CBT) for selected patients who have LBP along with risk factors for persistent LBP. CBT is designed to help patients identify and overcome barriers to recovery.

Clinics will be randomly assigned to one of the two arms of the study—PCP usual care or PCP plus PT-CBT—in a cluster randomized trial approach. At each of five regional sites (Pittsburgh, PA; Salt Lake City, UT; Boston, MA; Baltimore, MD; and Charleston, SC), 12 PCP clinics will participate. We expect to recruit 2,640 patients and have data on 2,400 of them six months after they enroll. All the patients will start the study when their LBP is in an acute phase—that is, they have not had persistent pain, defined as being in pain at least 50 percent of the time, for six months.

At 6 and 12 months, we will compare the proportions of chronic LBP between the two groups; compare how well patients perform such activities as sitting, standing, walking, lifting, traveling, and sleeping that typically bother people with LBP; and measure the number of low-back-related x-rays, MRIs, surgeries, and other medical procedures.

This proposed 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. In addition, patient co-investigators will serve on the steering committee and will participate in monitoring the project from its inception to the dissemination of the study results.

All previous studies detailing the success of the PCP plus PT-CBT approach were conducted in Europe. Therefore, before we can recommend any approach, it should be thoroughly and rigorously tested in the United States. We believe the proposed study is comprehensive and should be highly generalizable because it includes five distinct geographical areas. We will be targeting a large number of patients compared with previous studies. Finally, we will be conducting a randomized trial, the strongest study design, which should provide definitive information about whether to recommend the approach. If our results replicate those found in the European studies, we will be able to quickly disseminate them and facilitate implementation of the procedures in all other parts of the country, ultimately reducing the pain and suffering of people with chronic LBP.

Source: Patient-Centered Outcomes Research Institute

Term 5 years

Amount $13,915,897