The University of Pittsburgh will lead a $14 million clinical trial to determine how well an intervention that helps people better understand their back pain early on works toward promoting recovery and keeping the pain from becoming chronic down the road. UPMC will be the first in the trial to offer the intervention, followed by four other academic medical centers nationwide.
The five-year award from the Patient-Centered Outcomes Research Institute (PCORI) is the 13th and largest to come in to Pitt and UPMC through the Comparative Effectiveness Research Center housed in the university’s Health Policy Institute. This Center bridges Pitt’s Schools of the Health Sciences and UPMC, providing a multidisciplinary platform and research infrastructure for patient-centered comparative effectiveness research across all of the health sciences.
The Pitt-led study will examine the transition from acute lower back pain to chronic lower back pain, and compare two approaches that can be delivered in a primary care office. The first approach allows physicians to do what they think is best, which is termed “usual care.” The second approach teams up physicians with physical therapists to deliver cognitive behavioral therapy, a specialized therapy designed to help patients put their lower back pain in perspective, allowing them to identify and overcome barriers to recovery.
“Certain patients are more inclined to worry that when their back hurts they are further harming it, causing them to become inactive,” said lead investigator Anthony Delitto, Ph.D., chair of the Department of Physical Therapy in Pitt’s School of Health and Rehabilitation Sciences. “That can seriously impede recovery, cause further damage and lead to chronic back pain. Once the problem becomes chronic, the effects are magnified, even causing some people to lose their jobs and have prolonged difficulty with most daily activities. Chronic lower back pain is clearly something we would like to avoid.”
Lower back pain accounts for about $86 billion in health care expenditures every year, according to a study in the Journal of the American Medical Association. A major focus of the Affordable Care Act is mandating studies to examine pain as a public health problem and look for solutions.
“Our Comparative Effectiveness Research Center was created to provide the infrastructure to support these larger, pragmatic studies,” said Sally C. Morton, Ph.D., director of Pitt’s Comparative Effectiveness Research Center and chair of the Department of Biostatistics at Pitt’s Graduate School of Public Health. “We built the necessary methodological expertise and data environment to allow researchers to answer the questions facing our health system that are important to patients. Ultimately, these taxpayer investments through PCORI will improve outcomes and inform national policy and practice. ”
Dr. Delitto’s study, called TARGET, will recruit 60 primary-care clinics affiliated with UPMC, Intermountain Healthcare, Johns Hopkins Hospital and Health System, Boston Medical Center and The Medical University of South Carolina. At each site, 12 primary-care clinics will be randomly assigned to one of two study arms: the usual care their physician would prescribe for lower back pain or primary care coupled with physical and cognitive behavioral therapy.
Across the five regional sites, the team expects to recruit 2,640 patients with acute lower back pain, which is defined as pain they feel less than half the time and have had for less than 6 months. These patients will be evaluated with a standardized test that characterizes their response to pain and their predisposition to psychosocial characteristics that cause them to avoid pain out of fear.
The study will compare a patient-centered outcome that asks how well the patients perform activities that typically bother people with lower back pain, such as sitting, standing, walking, lifting, traveling and sleeping. Finally, the research team will measure the number of X-rays, MRIs, surgery and other lower back-related medical procedures for all patients enrolled in the study.
“This is the heart of patient-centered comparative effectiveness research,” said Everette James, J.D., M.B.A., director of Pitt’s Health Policy Institute. “Our mission is to use real-life research to find the right treatment for each patient at the right time.”
The PCORI award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.