The National Institutes of Health (NIH) estimates that in 2018, over 10 million teens and adults misused opioids. The prescription of opioids to treat patient pain is one of many factors contributing to this epidemic; to solve it, a multipronged approach is needed.

Two new Mayo Clinic studies — one in clinical practice and one in the laboratory — could offer new solutions to help patients manage pain without the use of opioids. These projects have been singled out for federal funding under the NIH’s Helping to End Addiction Long-Term (HEAL) Initiative, a multimillion dollar, multiorganizational approach to providing pain-treatment alternatives and turning the tide on the opioid crisis.

“Opioids remain one part of the continuum of pain treatment,” says Andrea Cheville, M.D., a rehabilitation physician at Mayo and member of the National Academy of Medicine. “There are other options that work as well, or better in some cases, with fewer risks. Our new research mirrors a broad Mayo priority — finding the safest, most effective way to help our patients manage acute or chronic pain.”

First, do NOHARM

Dr. Cheville and Jon Tilburt, M.D., a general internal medicine physician and biomedical ethics researcher at Mayo, are leading an enterprise-wide research team that will assess nonopioid pain management tools in everyday clinical practice.

The project, NOHARM (Non-pharmacological Options in postoperative Hospital-based And Rehabilitation pain Management), will test a set of decision-making tools aimed at helping doctors and patients decide together whether a nonopioid option is the best, safest option for pain after surgery.

While opioids are still often prescribed for postsurgical pain, alternatives such as over-the-counter medication like ibuprofen or simply better management of patient expectations can be a safer first option. Researchers know that when decision-making conversations about pain treatment occur between doctor and patient, the results are typically in line with guidelines aimed at reducing opioid overuse.

To ensure the new decision-making tools work well for patients and physicians alike, NOHARM researchers will work alongside clinicians across 18 areas, such as colorectal, gynecological and orthopedic surgery. The tools will be embedded within electronic health records, making their use as seamless as possible.

“This research will address some of the burning questions of our day: Can we minimize unintended prolonged opioid use after surgery by empowering patients with better, safer symptom management options? And can we make that approach the new normal across our whole organization and beyond? This strikes at the heart of medicine’s ‘first do no harm’ ethic,” says Dr. Tilburt.

NOHARM is known as a pragmatic clinical trial, a method of testing strategies in everyday clinical practice, typically with broad inclusion criteria, flexible implementation and a mix of interventions that work with how the practice already functions. Pragmatic trials allow researchers to see how an intervention works in real-world practice and discern its impact in different care environments.

An individualized approach to predicting pain

At the other end of Mayo’s research continuum is a NIH R33/61 study by Catherine Chong, Ph.D., and her team, entitled “Biomarker Signature to Predict the Persistence of Post-traumatic Headache.”  Post-traumatic headache can be a debilitating condition after concussion. Currently, there are no adequate methods to predict whether a person with post-traumatic headache will recover or will have persistence of post-traumatic headache. Clinical experience suggests that early treatment is most effective, before headache patterns become persistent. However, treating all patients with post-traumatic headache means that some individuals could receive potentially addictive medication that they do not need. In addition, overtreating post-traumatic headache can lead to medication overuse, which in turn can worsen headache symptoms.

The goal of Dr. Chong’s  study is to identify a prognostic biomarker signature that will accurately predict the persistence of post-traumatic headache using clinical data and structural and functional brain neuroimaging data collected in the semi-acute post-concussion phase. The ability to predict who will develop persistent post-traumatic headache would help clinicians to identify those individuals likely to progress to persistent headaches, and thus more precisely tailor interventions.

“Clinicians lack the information needed to make informed treatment decisions for these patients. We hope that we will be able to identify a biomarker that will identify those at high risk for persistent post-traumatic headache,” says Dr. Chong. “Should we be successful, a biomarker signature would help clinicians determine how aggressively to manage patients with post-traumatic headache during the acute phase of concussion and enable clinicians to better personalize treatments for each patient.”

Mayo’s commitment to addressing the opioid epidemic

“Mayo has long been a hub for foundational research on addiction, rehabilitation, surgical care, data analytics, medical records and quality of life,” says Dr. Tilburt. “These new projects represent the kind of organizational responses needed to address the opioid crisis. We want to make sure our efforts to help and heal don’t create paradoxical effects for those at high risk for prolonged opioid use.”

“It’s clear this is a priority for our institution, and we’re excited to get to work,” he says.

For more information on addiction research and other biomedical research at Mayo Clinic, visit www.mayo.edu.

- Elizabeth Zimmermann, October 2019

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