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 thirteenth and largest to come in to Pitt and UPMC through the Comparative Effectiveness Research Center housed in the university’s Health Policy Institute and directed by Dr. Sally C. Morton, chair of the Department of Biostatistics at Pitt’s Graduate School of Public Health. 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.
“Our Comparative Effectiveness Research Center was created to provide the infrastructure to support these larger, pragmatic studies,” said Dr. Morton. “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. ”
The trial, 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.
“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 Dr. Anthony Delitto, 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.”