(Boston) – March 6, 2015 – Boston Medical Center (BMC) researchers are part of a national clinical trial that will examine how best to treat acute low back pain and potentially prevent it from being chronic. BMC will receive $2.3 million for its role in the five-year study that was recently approved for a $14 million award by the Patient-Centered Outcomes Research Institute (PCORI). BMC joins four academic medical centers that will recruit patients in order to determine the efficacy of an intervention aimed at treating peoples’ back pain early on in order to promote recovery and keep the pain from becoming a chronic health issue.
Robert Saper, MD, MPH, director of integrative medicine and a family physician at BMC, will serve as co-principal investigator for the study and will oversee all of the Boston-area activities. The national, multi-site study will be led by Antony Delitto, PhD, vice president of education and research for the Centers for Rehab Services, associate dean for research in the School of Health and Rehabilitation Sciences and Physical Therapy professor at the University of Pittsburgh.
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 that will look for practical solutions to problems that matter to patients, such as back pain. Persistent low back pain (LBP), often referred to as “chronic low back pain,” can cause prolonged difficulty with most daily activities and can even prevent some people from being able to perform work-related duties, resulting in job loss. Most patients see primary care physicians (PCPs), physical therapists, or chiropractors for LBP.
This study will look at the transition from acute LBP to chronic LBP and compare two treatments that can be delivered in an outpatient PCP setting. The first approach will allow PCPs to do what they think is best, termed “usual care.” The second will have PCPs team up with physical therapists to deliver – as early as possible – physical therapy with cognitive behavioral coaching, targeting patients who are at high risk for not improving.
“This is the first study to determine whether prompt evidence-based physical therapy with a cognitive behavioral component can actually prevent chronic low back pain,” said Saper, also associate professor of family medicine at Boston University School of Medicine who has led numerous clinical trials on nonpharmacologic interventions, such as yoga and physical therapy, to treat lower back pain in underserved patients. “Typically, prevention efforts have focused on common conditions such as heart disease, diabetes, and cancer. This study is exciting because it will expand the prevention paradigm to include hard-to-treat expensive pain disorders.”
This study will recruit 60 primary-care clinics – and 2,640 patients – affiliated with BMC, University of Pittsburgh Medical Center, Intermountain Healthcare in Utah, Johns Hopkins Hospital and Health System, 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 therapy and cognitive behavioral coaching. Patients will be targeted who score high on a standardized test that characterizes their response to pain and psychosocial variables that may cause them to have more difficulty improving.
For evaluations, the patients will be asked how well they perform activities that typically bother people with LBP, such as sitting, standing, walking, lifting, traveling and sleeping. In addition, the research team will measure the number of X-rays, MRIs, surgeries and other lower back-related medical procedures for all patients enrolled in the study.
“BMC’s diverse patient population faces a disproportionate higher burden of chronic pain and extraordinary barriers to effective medical and non-pharmacologic treatments,” said Paula Gardiner, MD, MPH, a co-investigator for the study and assistant director of integrative medicine and a family physician at BMC. “This study has the potential to make a substantial lasting impact on our patients’ quality of life.”
The funding award for the national study has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract. PCORI is an independent, nonprofit organization authorized by Congress in 2010 to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions.