National pain research registry study finds long-term opioid therapy ineffective

Dr. Licciardone
Dr. Licciardone

The Journal of the American Board of Family Medicine has published an article on long-term opioid therapy based on national data from the Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation, which is headquartered at The University of North Texas Health Science Center at Fort Worth.

The study findings revealed that LTOT, commonly defined as opioid use for more than 90 days, did not improve outcomes among patients with chronic low back pain who were monitored for up to 12 months. Opioid dosage, measured in daily morphine milligram equivalents, did not affect outcomes. Analyses involving patients who used opioids continuously for 12 months showed they had greater pain and disability than control patients who did not use opioids.

The research team was led by John C. Licciardone, DO, MS, MBA, who serves as director of the registry, known as PRECISION. Other investigators included Subhash Aryal, PhD, a registry biostatistician affiliated with the University of Pennsylvania, and Kush Rama, BS, Antoine Nguyen, BS, Cynthia Ramirez Prado, MS, and Chandler Stanteen, MS.

“To our knowledge, this is the first study within the general population to follow patients on LTOT for up to one year,” Licciardone said. “It is very difficult to conduct randomized controlled trials of LTOT for logistical reasons and because of ethical concerns with assigning patients to receive LTOT, given its potential risks.”

Kush Rama
Kush Rama

The study’s retrospective cohort design enabled the researchers to collect longitudinal data on patients who joined the registry between 2016 and 2022 and then provided quarterly updates on opioid use and clinical outcomes. Patients who were on LTOT and control patients were initially matched using propensity scores based on comprehensive sociodemographic and clinical characteristics to simulate the results that would have been observed in a randomized controlled trial.

“Randomized controlled trials remain the gold standard in assessing the efficacy of clinical interventions, such as opioid therapy,” Licciardone said. “However, in contrast to their implementation challenges, high costs and potential ethical concerns, PRECISION’s digital research platform offers a new paradigm to efficiently conduct opioid research in real-world settings.”

Several authors, including Rama, were medical students who completed additional training in clinical research.

“The opioid crisis has been a long-standing issue in America, and the research that we conducted reveals important information for clinicians,” Rama said. “I hope our research encourages clinicians to consider alternatives to opioids or, if opioids are used, tapering down the dose early in accordance with clinical guidelines.”

In addition to opioids, researchers at PRECISION are conducting studies that involve other emerging areas of interest in chronic pain epidemiology and treatment, including such aspects of the patient-physician relationship as empathy and communication, and racial health disparities.

The full text of the article can be found here ahead of print. To learn more about PRECISION, contact Samantha Johnson at samantha.johnson@unthsc.edu or 817-735-0532.

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