Funded Projects

Data suggest that members of minority groups are more likely to develop chronic pain and to have greater pain burden. We will identify a set of promising intervention targets for reducing or eliminating racial/ethnic pain disparities. We will interview adult survivors of serious physical injury, comprised of roughly equal proportions of African-Americans (AA), Latinos, and non-Latino Whites (NLW), and examine their medical records for information on injury severity and medication use in-hospital. Our aims are to determine whether: 1) AA and Latino physical injury survivors experience more severe pain relative to NLW; 2) AA and Latino injury survivors experience greater pain burden relative to NLW counterparts; 3) differences in pain severity burden are linked to a set of target candidates for interventions; and (4) pain outcomes in at-risk minority groups can be linked to a set of target candidates for group-tailored interventions to reduce pain severity and pain burden.

There are currently no reliable tools to measure pain objectively, and health care providers must rely on patient’s subjective reports and observations of patient behavior to determine the level of pain a person experiences. This hampers both effective pain management and the development of new pain medications. This project will assess an imaging technology called Radiocaine that in animal studies has been able to identify the origin of pain as well as its intensity. The goal is to use Radiocaine in clinical trials for pain treatments, thereby enhancing treatment effectiveness and facilitating development of new treatments.

A main goal of the NIH HEAL Initiative and the Early Phase Pain Intervention Clinical Network (EPPIC-Net) is to improve non-opioid pain management. This award will leverage the resources at one of EPPIC-Net’s Specialized Clinical Centers by implementing and evaluating strategies to improve the engagement, recruitment, and retention of individuals from underserved racial/ethnic minority populations to participate in EPPIC-Net clinical trials. Since environmental, cultural, and genetic factors may account for observed differences in pain responses between racial and ethnic groups, enrollment of a diverse sample in pain research is crucial to obtain a complete understanding of the effectiveness of any proposed pain therapeutic intervention. The success of these activities will be evaluated, and a toolkit will be created to define best practices that can be by other EPPIC-Net sites and additional trials.

Chronic pancreatitis is a painful condition often caused by long-term alcohol use, and patients often require treatment with strong pain medications, including opioids. Therefore, alternative treatments for chronic pancreatitis are needed. This project will use machine learning approaches to create a prediction tool based on electroencephalography analyses, sensory tests, and psychological questionnaires that can help determine which patients with chronic pancreatitis will benefit most from a specific type of treatment called endoscopic therapy.

A major barrier to developing new pain treatments has been the absence of infrastructure to facilitate well-designed and carefully conducted clinical trials to test the efficacy of promising treatments. The UF Health Specialized Clinical Center Network will include UF Health as “hub” and statewide partners serving as spokes as part of the EPPIC Network. The University of Florida (UF) has the capability to reach more than 50% of the population of Florida, the third most populous state of the United States, and the capacity to successfully enroll patients with varying pain conditions into clinical trial protocols through its hub and spoke infrastructure as part of EPPIC-Net.

Chronic low back pain affects millions of people in the United States, resulting in high medical costs and lost productivity. New opioid-free treatments are needed to help people with chronic low back pain, but not all people respond equally to a given approach. IMPACT aims to use machine learning to analyze data such as physical activity, sleep, emotions, and pain levels and identify markers that can help predict how effective a mindfulness-based treatment approach (Mindfulness-Based Stress Reduction) can be for people with chronic low back pain.

Enhancing the workforce of pain investigators and practitioners is a key goal of the NIH HEAL Initiative. This mentoring award leverages the resources at one of EPPIC-Net’s Specialized Clinical Centers to encourage interest in clinical pain management, in particular through multidisciplinary pain research projects. A selected investigator will train early career clinical researchers on how to develop and validate relevant pain measures and outcomes in chronic pain conditions, including chemotherapy-induced peripheral neuropathy and neuropathic chronic low back pain. Mentoring activities will include formal research and analysis, active inclusion in EPPIC-Net working groups, and collaborative writing experiences.

Improving pain treatment for is a major goal of the NIH HEAL Initiative. This award supports an early career physician toward achieving a future in clinical pain research and in conducting phase II clinical trials focused on pain. Research activities will provide this individual with the skills needed to serve as a primary investigator for future clinical trials in chronic pain and will help to answer a key question that could improve the design of analgesic clinical trials for neurogenic intermittent claudication, a distinct form of chronic low back pain for which no available treatment exists.

Enhancing the workforce of pain investigators and practitioners is a key goal of the NIH HEAL Initiative. This mentoring award will allow a selected investigator to train early career investigators in patient-oriented research focusing on the development of diagnostic and prognostic biomarkers for high-impact chronic pain. Mentoring activities will include training in designing and implementing pain research studies, preparing scientific papers and presentations, writing successful grant applications, the responsible conduct of research, and successful navigation of the academic process to achieve scientific independence. This training will allow mentees to advance their independent careers as pain researchers.

The Icahn School of Medicine at Mount Sinai (ISMMS) will support the mission of the Early Phase Pain Investigation Clinical Network (EPPIC-Net), through the ISMMS Department of Neurology as the core of a hub and spokes structure. The study contains four specific aims: (1) to streamline and optimize rapid implementation of EPPIC-Net studies, exceeding the required minimum of 100 subjects recruited per year to EPPIC-Net studies; (2) to ensure access to patient populations with a wide range of pain disorders, including CLBP, using a hub and spokes model to ensure effective recruitment; (3) to provide the highest-quality protocol implementation, deep clinical phenotyping of pain disorders, and accurate and complete data collection; and (4) to work collaboratively with the EPPIC-Net Coordinating Centers and investigators from the NIH HEAL Partnership to assist with development/design of clinical trials. The study team will also increase training opportunities through EPPIC-Net within ISMMS and the larger pain research community, training junior investigators to become future pain clinical trials leaders and increase and disseminate knowledge about pain research throughout the network.

The Medical University of South Carolina (MUSC) Specialized Clinical Center (Hub) of the Early Phase Pain Investigation Clinical Network (EPPIC-Net) will provide a robust and readily accessible infrastructure for rapid implementation and performance of high-quality comprehensive studies of novel treatments for patients with a wide variety of pain conditions. The MUSC-Hub will harness multidisciplinary clinical, research, statistical, and data management expertise to provide the scientific leadership and infrastructure required to design and conduct multisite Phase II clinical trials, biomarker validation studies, and deep phenotyping of patient populations as part of the EPPIC-Net with the overall goal of accelerating the development of new therapies for patients with acute and/or chronic pain.

Managing persistent pain has long been a difficult challenge, one that is heightened by the recent opioid crisis. Although many potential solutions may exist, demonstrating their efficacy in a multicenter trial is a considerable obstacle. There is broad consensus that a nationwide clinical research network is necessary to promote innovation. A hub-spoke complex of academic medical centers with considerable experience in pain management clinical trials and biomarker validation will leverage existing resources to make clinical trial execution efficient and rapid. Together, spokes will provide maximum flexibility, ready to accommodate studies in any well-characterized pain condition.