Devices & Diagnostics

Can a ‘smart’ pain management system be alternative to opioids for chronic pain?

NeuroMetrix is adding a digital twist to the humble transcutaneous electrical nerve stimulation device to provide pain relief and be a non-drug alternative to chronic pain.

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Quell is a transcutaneous electrical nerve stimulation (TENS) device wraps around the calf to block pain and can also track patient use and sleep pattern

Around 100 million Americans suffer from chronic pain. To complicate matters, millions are also struggling with opioid addiction, driving intensive efforts to find pain management alternatives.

“A lot of people are suffering from lower back pain, sciatica, fibromyalgia, arthritis, diabetic nerve pain. These are people who have been dealing with pain for months or years,” said Frank McGillin, senior vice president and general manager of Consumer Health at NeuroMetrix in a phone interview. “One common thread is they’re not satisfied with their current level of relief, and they’re really looking for something that is drug-free.”

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McGillin believes that Waltham Massachusetts-based NeuroMetrix may have a solution in Quell, the company’s high-frequency transcutaneous electrical nerve stimulation (TENS) device, which has been approved by the FDA for over-the-counter use.

“By stimulating the nerves at the right frequency, over the right period of time, it stimulates a response in the central nervous system, releasing an endogenous opioid, a natural pain blocker,” he said.

NeuroMetrix was founded 20 years ago by Shai Gozani, a product of the Harvard-MIT Division of Health Sciences and Technology. Initially, the company focused on neurodiagnostics – finding better ways to study nerve conduction. They still offer NC-stat, which tests for peripheral neuropathies, but these efforts to understand how the body is wired led them to therapeutics, such as SENSUS, their prescription version of Quell. Now the company is transitioning from digital devices to consumer health.

They are not alone and TENS is not a new approach. The technology was developed in the 1970s, and many companies are embracing it. Axiobionics has been making electrical stimulation devices for two decades, and a quick TENS search on Amazon produces dozens of devices.

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

But McGillin said Quell may offer a better solution for many people. The self-contained device attaches around the calf and can be operated through iOS or Android operating systems. Internal algorithms help customize the electrical dose for each user and monitor safety. Quell also comes with a digital health platform, which can track compliance, as well as sleep patterns.

“There’s a linkage between chronic pain and sleep,” noted McGillin. “If you’re not sleeping, it can exacerbate your pain.”

Using a TENS device while sleeping is a tricky area, as there can be a burn risk. However, Quell has been approved by the FDA for sleep use. In October, NeuroMetrix received a patent for features that help the device monitor skin/electrode impedance – a new technology to enhance safety.

NeuroMetrix continues to study Quell. This year the company published a safety and efficacy study, led by Gozani. The trial found that the therapy was safe and, among 88 participants, more than 80 percent responded to the treatment.

In June, NeuroMetrix announced a new study with Scripps Translational Science Institute to investigate how Quell impacts opioid use in cancer patients. The startup is also working with Brigham and Women’s Pain Management Center to study Quell’s effectiveness for patients with chronic low back pain.

Given the dual epidemics of pain and addiction, non-drug approaches like Quell may carve out a long-term niche.

“More than half of people suffering from chronic pain aren’t satisfied with their current treatments,” said McGillin. “They want alternatives.”

Photo: NeuroMetrix