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In collaboration with Children’s National Hospital and Johns Hopkins University, MedStar Health Research Institute will undertake a series of studies of a new device that could revolutionize our understanding of pain.
If you have ever been asked to describe your pain by pointing to a scale of grimacing faces, you know our understanding of pain is somewhat limited. A new collaborative project funded by the Advanced Research Projects Agency for Health (ARPA-H) could fundamentally change how we think about pain—from a feeling patients are asked to describe to a physiological response we can objectively measure.
The project led by principal investigator Julia Finkel, M.D. is a collaboration between Children’s National Hospital, Johns Hopkins University, and MedStar Health Research Institute, specifically the Center for Biostatistics, Informatics, and Data Science (CBIDS) MedStar-Georgetown Collaborative Center for Artificial Intelligence in Healthcare Research and Education (AI CoLab). We’re working together to advance the AlgometRx Nociometer, a device that could help providers more precisely, objectively measure and understand patients’ pain.
Statistics from the Centers for Disease Control and Prevention reveal that about 1 in 5 adults in the U.S. lives with chronic pain. Pain is subjective, and asking patients to assess their pain can lead to poor outcomes—it oversimplifies the many different types of pain people can experience. It reduces our inability to provide high-quality care and lowers the quality of life for many people. Pain is acknowledged as a primary driver of the opioid crisis, which claimed more than 80,000 lives from overdose in 2023.
Pain is a crisis, with healthcare costs estimated to range from $261 billion to $300 billion. If you include lost work and wages, the total cost to society jumps from $560 billion to $635 billion—more than the cost of cancer and diabetes combined.
This exciting collaboration, Sprint for Women’s Health, is funded by the Advanced Research Projects Agency for Health (ARPA-H), a research funding agency supporting significant healthcare advances. Our work could lead to a transformative medical breakthrough that could revolutionize how we think about and respond to pain.
Designing studies and interpreting real-world data.
Exploring this breakthrough technology encompasses a five-year series of studies and activities to explore, understand, and prepare the sociometer for approval by the Food and Drug Administration.
Women and girls are more likely to have chronic pain conditions than men or boys and often report more severe pain and more skepticism from providers. One of the project’s goals is to enhance our understanding of how gender affects pain, allowing for improved care for everyone.
CIBDS is playing an essential role in this collaborative project. Our team has specialized expertise in working with electronic health records and extensive experience with large sets of real-world data. We are committed to designing studies and validating the resulting data to ensure that this important technology can be studied rigorously and efficiently.
More specifically, our team will:
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Support study design for several pilot and pivotal studies.
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Lead the analysis and interpretation of the results for all the pilot studies and clinical studies
Understanding types of pain.
Pain involves several processes in the body, which can be different for everyone. It comes in three main types:
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Normal nociceptive pain: Pain that follows an injury or surgery
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Neuropathic pain: When nerves are the source of pain, such as in diabetic neuropathy
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Inflammatory pain: Pain associated with inflammation, such as in lupus or inflammatory bowel disease
Chronic pain can also lead to a fourth type—nociplastic pain. Fibromyalgia is one example of this type of pain, in which changes to the central nervous system lead to abnormal sensory processing.
A non-invasive, objective measure of pain.
It can be challenging to communicate how pain feels, especially for patients who may not have speech or enough vocabulary, such as young children or adults with dementia. Communication barriers can be a source of diagnostic and care modification errors that could significantly impact treatment.
Our collaborators have identified a non-invasive way to assess pain by measuring how a patient’s pupils dilate in response to mild stimulation. The device can illuminate, like never before, which type of pain a patient has and its severity.
This project and this device are inspiring. Early pilot studies have demonstrated its effectiveness, and we are now finalizing the study design for more robust explorations of its ability to measure the different types of pain so patients can get precise treatment.
Expertise in high-quality research benefits patients.
At CBIDS, our expertise in high-quality statistical methods, clinical informatics, data science, and the development of health information technology applications makes us in-demand collaborators. Our work is to engineer (or reengineer) the best biomedical research, no matter which discipline or disease area it addresses.
We are pleased to be a part of this vital project, and our teams are working to ensure top-of-the-line research and data analysis help make the AlgometRx Nociometer a reality for patients and providers everywhere. Meaningful collaborations like this, with funding that recognizes the transformational nature of this project, can make a significant difference in patients’ lives.