TCOM’s Dr. John Licciardone co-authors JAMA article on the PACBACK Trial
John Licciardone, DO, MS, MBA, regents professor in the Texas College of Osteopathic Medicine at UNT Health Fort Worth, collaborated with colleagues at leading pain research centers to publish initial results of the PACBACK Trial in JAMA.
The landmark study funded by the National Institutes of Health measured the effectiveness
of spinal manipulation and clinician-supported self-management compared with guideline-based
medical care for patients with acute or subacute low back pain at increased risk of
chronic disabling pain. It included 1,000 patients at three research clinics in Minnesota
and Pennsylvania from November 2018 to June 2024.
Patients were randomly assigned to one of four groups that received either spinal
manipulation, clinician-supported self-management, both treatments combined, or medical
care. The trial protocol was temporarily modified during the COVID-19 pandemic by
remotely delivering clinician-supported self-management and medical care and not assigning
patients to the treatment groups receiving spinal manipulation.
The treatments lasted 8 weeks and outcomes were measured over 12 months. A visual
summary of the primary outcomes shows that the clinician-supported self-management
and combined treatment groups reported significantly less disability than the medical
care group, but that spinal manipulation alone did reduce disability compared with
medical care. The differences between groups in pain intensity were not considered
significant.
“It's gratifying to see the conception, design, and implementation of this study come
to fruition with its completion and publication in JAMA,” said Licciardone, who is
also executive director of the Osteopathic Research Center at UNT Health. “This new
evidence on biopsychosocial self-management should be helpful in updating clinical
guidelines for treating acute and subacute low back pain.”
The ORC previously conducted several clinical trials that focused on osteopathic manipulative
treatment as an intervention for chronic low back pain. The OSTEOPATHIC Trial, which
was funded by the National Institutes of Health to study 455 patients, found that
OMT delivered over 3 months substantially reduced low back pain intensity while also
decreasing the need for prescription pain medication and improving patient satisfaction.
“Upon completing the OSTEOPATHIC Trial, I wanted to conduct a long-term study to extend
its OMT findings,” Licciardone said. “After applying for another grant and conferring
with the director and program officer at the National Center for Complementary and
Integrative Health, I learned that they were interested in funding a larger trial
that would also include physical therapists and chiropractors and would be considered
a ‘game changer.’”
The ORC subsequently convened a series of teleconferences that included Dr. Gert Bronfort
and researchers who now comprise the PACBACK Leadership Team at the University of
Minnesota, University of Pittsburgh, Duke University, Oregon Health Sciences University,
and University of Washington, along with UNT Health.
“It was both challenging and rewarding to work with leaders in pain research to develop
a clinical trial protocol that could include spinal manipulation provided by physical
therapists, chiropractors, and osteopathic physicians,” said Licciardone. “There was
a precedent with the UK BEAM Trial, wherein physiotherapists, chiropractors, and osteopaths
agreed to a common treatment protocol for low back pain.”
However, unlike osteopaths in the United Kingdom who focus primarily on manual therapies,
osteopathic physicians in the United States take a whole-person approach to patient
care. In addition to empathic communication with patients, this may involve OMT as
well as prescription medication, invasive procedures, or lumbar spine surgery when
indicated for low back pain.
The ORC expanded its research agenda in 2015 to study the overall impact of osteopathic
medical care rather than focusing only on OMT. It also established new research priorities
involving the patient-physician relationship, benefits and harms of opioid therapy,
and racial health disparities in pain medicine.
The Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation
(PRECISION) was established in 2016 to serve as the vehicle for addressing the ORC’s
new research priorities. The registry now uses a digital research platform and electronic
data capture to study thousands of patients nationwide, including many with chronic
low back pain.
“The use of registries, such as PRECISION, was hailed as potentially the next disruptive
technology in clinical research at the time,” Licciardone said. “PRECISION can now
enroll and follow large numbers of patients at low cost. It may also provide better
clinical insight by including more representative patient samples in our research.”
Although Dr. Licciardone serves on the PACBACK Leadership Team, the ORC eventually opted not to participate as a recruitment and treatment site because of its other research priorities at the time.
“Nevertheless, the study results corroborate what we observed in our prior osteopathic research,” Licciardone said. “Patients treated by osteopathic physicians who advise them on the biopsychosocial aspects of their pain generally achieve better outcomes.”