Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients: A Multi-Site Pragmatic RCT
Low back pain (LBP) is a common problem among US adults. Initial episodes tend to be self‐limited, but some people can progress to a state of persistent pain. Often termed “chronic low back pain,” this condition can cause prolonged difficulty with most daily activities, including job performance. Most patients see chiropractors or primary care providers (PCPs) for initial episodes of LBP. This study will compare two approaches for preventing patients with acute LBP from developing persistent LBP. 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 acute to persistent LBP 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 for those patients determined to be at high risk for transitioning to persistent LBP. Psychologically informed physical therapy is designed to help patients identify and overcome physical and psychological barriers to recovery.
Clinics will be randomly assigned to one of the two arms of the study—PCP provided with risk information or PCP provided with risk information plus psychologically informed physical therapy—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), at least 12 PCP clinics will participate. We expect to recruit 3,000 patients and have data on 2,640 of them six months after they enroll. All of the patients will start the study when their LBP is in an acute phase—that is, they do not have persistent pain, defined as being in pain at least half 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 activities that typically bother people with LBP, such as sitting, standing, walking, lifting, traveling, and sleeping; and measure the number of low back‐related x‐rays, MRIs, surgeries, and other medical procedures. The same outcomes will be assessed for an observational cohort of 9,000 patients at low to medium risk for transitioning to persistent LBP across the five sites.
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. In addition, patient co‐investigators serve on the steering committee and will participate in monitoring the project from its inception to the dissemination of the study results.