A new clinical trial, led by the University of Pittsburgh, aims to compare strategies intended to treat back pain and help avoid surgery. A 5-year award from the Patient-Centered Outcomes Research Institute (PCORI) funds the $14 million clinical trial, according a university news release. The award is the 13th and largest to come in to Pitt and UPMC through the Comparative Effectiveness Research Center, which is located in the university’s Health Policy Institute.
The release reports that the study will investigate the transition from acute lower back pain to chronic lower back pain, comparing two approaches that can be delivered in any primary care office. The first approach allows physicians to do “usual care.” The second approach partners physicians with physical therapists to deliver cognitive behavioral therapy, which is designed to assist patients in putting their lower back pain in perspective, allowing them to identify and overcome barriers to recovery.
Anthony Delitto, PhD, chair of the department of Physical Therapy in Pitt’s School of Health and Rehabilitation Sciences, explains in the release that certain patients are more prone to worry, fearing that when their back hurts they are further harming it. This causes them to become inactive.
“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,” Delitto says.
The Comparative Effectiveness Research Center was created to offer the infrastructure to support these types of larger, pragmatic studies, according to Sally C. Morton, PhD, director of Pitt’s Comparative Effectiveness Research Center, 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,” she adds in the release.
Delitto’s study, known as TARGET, is slated to 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. The release notes that at each site, 12 primary care clinics will be randomly assigned either the “usual care” a physician would prescribe for lower back pain or primary care blended with physical and cognitive therapy.
The release states that across the five regional sites, the team anticipates the recruitment of 2,640 patients with acute lower back pain. Acute lower back pain is being defined as pain patients feel less than half of the time and have had for less than 6 months. The 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 then compare a patient-centered outcome, which asks how well the patients perform activities that typically bother individuals with lower back pain, such as sitting, standing, walking, lifting, traveling, and sleeping. Finally, the release says, 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.