Patrick Heagerty, of the University of Washington School of Public Health, has received $2.8 million from the National Institutes of Health (NIH) to lead the data coordinating center for a study of non-drug approaches for preventing chronic low back pain, which could lead to reduced opioid use.
Heagerty, chair and professor of the Department of Biostatistics, will provide data management and statistical leadership for the study, a multi-site clinical trial examining the effectiveness of spinal manipulation therapies and supported self-management compared to usual medical care.
Additionally, the first phase of a cooperative $11.2 million NIH grant was awarded to the University of Minnesota’s Earl E. Bakken Center for Spirituality & Healing and the University of Pittsburgh to manage the study’s clinical coordinating center.
According to the World Health Organization (WHO), low back pain is the leading cause of disability worldwide. The study, called Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain Trial (PACBACK), is one of the largest studies funded by the NIH’s National Center for Complementary and Integrative Health focused on back pain.
“A key challenge in the treatment of back pain is how to manage acute pain, and how to avoid progression to chronic pain," Heagerty said. "In our study, we will evaluate two candidate treatments simultaneously in one study using a factorial design. In the trial, some patients receive only one treatment, some receive both, and some will receive neither and be given usual care."
Such a study design is efficient in allowing two treatments to be evaluated and is advantageous by permitting analysis of whether the two treatments when applied together have additional synergistic benefit, according to Heagerty. A total of 1,180 patients with low back pain will take part in the study, with enrollment beginning in spring 2018.
The researchers will compare spinal manipulation therapies and supported self-management to usual medical care, which includes prescription medications for the care of acute low back pain in adult patients at increased risk of becoming chronic. Supported self-management encompasses self-care strategies that address the biopsychosocial aspects of back pain through the use of behavioral and coping strategies, mind-body approaches, lifestyle advice and pain education.
Study collaborators include Dennis Turk, endowed chair in anesthesiology and pain research at UW Medicine; Gert Bronfort, Roni Evans, Brent Leininger, John Connett, Florin Orza and Joyce Whar, from the University of Minnesota; Anthony Delitto, Mike Schneider, Carol Greco, Natalia Morone and Joel Stevans, from the University of Pittsburgh; Roger Chou, from Oregon Health and Sciences University; Steven George, from Duke University; and John Licciardone, from the University of North Texas.