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Targeted interventions to prevent chronic low back pain in high-risk patients: a multi-site pragmatic RCT
Investigator (PI): Delitto, Anthony
Performing Organization (PO): (Current): University of Pittsburgh, School of Health and Rehabilitation Sciences, Department of Physical Therapy / (412) 624-6292
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2015
Final Year: 2020
Record Source/Award ID: PCORI/PCS-1402-10867
Funding: Total Award Amount: $12,174,689
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: 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. More on this project: In Care Transitions, a Chance to Make or Break Patients' Recovery--A narrative on what happens when patients are harmed by poorly executed transitions between healthcare settings. https://www.pcori.org/research-in-action/care-transitions-chance-make-or-break-patients-recovery
Abstract Archived: 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.

MeSH Terms:
  • Activities of Daily Living
  • Cluster Analysis
  • Cognitive Behavioral Therapy
  • Humans
  • Low Back Pain /*rehabilitation
  • Magnetic Resonance Imaging
  • Maryland
  • Massachusetts
  • Outcome Assessment, Health Care
  • Pennsylvania
  • Primary Health Care /*organization & administration
  • Randomized Controlled Trials as Topic
  • Research Design
  • Risk Factors
  • South Carolina
  • Treatment Outcome
  • United States
  • Utah
  • X-Rays
Country: United States
State: Pennsylvania
Zip Code: 15260
UI: 20153600
Project Status: Ongoing
Record History: ('2017: Abstract replaced.',)