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If you have been treated for pain since the mid-1990s, you’ve probably been asked to rate your pain level according to a chart numbered zero to 10, each number accompanied by a cartoon face that ranges from a comfortable smile to an agonized expression.
Such pain rating scales go back to the 1980s as a tool to help children express their pain level to healthcare providers, but the zero-to-10 happy-sad scale became ubiquitous in the ’90s, as part of a push to make pain a “fifth vital sign.” One of the organizations behind that push was the American Pain Society, which disbanded in 2019 as it faced numerous lawsuits alleging its role in fostering the opioid epidemic.
Dr. Michael Fishman, the co-founder of Wilmington-based Celéri Health and a practicing pain management specialist, says it’s time to move past the cartoon faces.
“When we talk about chronic pain, it affects everybody differently,” he said. That existing scale “is totally inadequate. What we want to do is create the best treatment based on real-world evidence. That evidence does not exist, so we have had to learn how to collect it ourselves from the ground up.”
Using National Institute of Health (NIH) metrics, Fishman, along with co-founder Dr. Jason Pope, a pain specialist based in California, and their team developed the Celéri Health Real World Outcomes Platform in 2018.
The platform, which is used by about 120 healthcare providers in 12 states, has 15 assessments, including an opioid risk screening tool and measurements of seven dimensions of pain. Assessments are taken either on the patient’s smartphone or a tablet provided by the healthcare office.
The challenge of pain measurement is its subjectivity — and, with a crisis like the opioid epidemic, the fact that it works as an honor system of sorts. A physician can’t measure pain in the way they can measure the blood sugar level of a patient with diabetes, for example. If a patient says they are at pain level six, under the zero-to-10 model, the chart stated that the patient should be given medication like oxycodone. Adherence to that has been tied to patient satisfaction, which was tied to hospital bonuses.
Celéri’s method, by contrast, is based on what’s called the biopsychosocial model.
“This is a standard that the NIH and some other commissions have set,” said Jon Brilliant, Celéri Health CEO. “We’re not reinventing the wheel, we’re taking consensus that’s out there and marrying it with clinically validated tools, giving our customers — and drug companies — better insights.”
Especially when it comes to chronic pain, the picture is much bigger than how much it hurts, and where Dr. Fishman said.
“It’s also how you interact with other people, what it prevents you from doing,” he said. “Alongside that is anxiety and depression, which coexist in chronic pain syndrome in the biopsychosocial model.”
Part of Celéri’s work is conducting clinical studies to help better understand pain measurement. Its current study uses the Medtronic Intellis Spinal Cord Stimulation (SCS).
The Medtronic Intellis is an implantable device that uses an accelerometer to track patient function and uses Bluetooth to adjust stimulation waves to relieve pain.”
“Historically, you would have a stimulator implanted and you would come to your doctor’s office every month and they would adjust it,” said Brilliant. “With this, the doctor can see you remotely, everything remote. COVID-19 highlighted the impact of this.”
The first patient, from a registry of patients that use Medtronic SCS therapy, joined the study at the end of January. The study will ultimately have up to up to 1,700 patients enrolled across 20 to 30 pain management centers in the United States.
The goal in their work, which will include an upcoming study measuring brain wave activity, Fishman said, is to make sure no one suffering from chronic pain is left behind.
“People with pain get ostracized,” he said. “Celéri Health started with us saying, ‘The zero-to-10 metrics are broken.'”