For Jennifer, Quell offered an easy, effective path away from a reliance on opioids. And Quell joins an ever-growing list of tech-based alternatives to prescription painkillers.
Finding other options can be hard in a market saturated with opioids. A 2011 report from the Institute of Medicine of the National Academies Press found that 100 million adults in the US suffer from chronic pain, with the national costs tied to the condition hitting up to $630 billion annually. Of course, these kinds of numbers are attractive to pharmaceutical companies making millions of pain pills.
Some groups have been fighting against the emphasis on opioids. For instance, states like Illinois, Mississippi and Ohio have each filed lawsuits against companies that produce the most prevalent opioid out there: oxycodone. That being said, opioids aren't going away anytime soon.
Companies like NeuroMetrix can't exactly make a huge dent in the painkiller market, but they can be part of a larger trend, moving the conversation away from drugs and toward tech-based treatments.
Devices that rely on electrical stimulation to treat pain are not new. The first transcutaneous electrical nerve stimulation (TENS) device was patented in 1974. Using electrical currents to excite parts of the nervous system, TENS devices usually connect to the wearer through electrodes that suction onto the skin. The electrodes are wired to a portable battery pack that is used to modulate the frequency of the electrical currents.
One problem with these devices -- which can be bought at common drug stores like CVS -- is that they only work for about 20 to 30 minutes per day. These are great for short-term, localized pain relief but are not necessarily helpful for long-term treatment.
NeuroMetrix President and CEO Shai N. Gozani said that his device is most effective because it provides a noninvasive, long-lasting solution for those with chronic pain.
"The electrical stimulation activates your body's endogenous opioids. You know, we actually have these opioids in our nervous system that naturally block pain. The electrical stimulation over the long term induces your body to produce these endogenous pain modulators, which creates pain relief in a very safe and nonaddictive way," Gozani said. "That is the concept that is central to our Quell platform: safe and nonaddictive."
Gozani's work started as postdoctoral research in 1996 -- he holds an MD from Harvard and a PhD in Neurobiology from University of California, Berkeley -- and it wasn't until 2011 when development started on the actual wearable. The first iteration officially launched in the form of an FDA-regulated device prescribed by a physician. While this version of the device proved successful, Gozani's real vision was for an accessible, over-the-counter product. Hence, Quell was born, hitting the market in June 2015.
"There's a lot of snake and oil to a lot of products out there, but I'm a physician. I'm trained."
"There was a lot of optimism and a lot of appropriate, healthy skepticism surrounding our device. I mean, there is a lot of desperation out there around chronic pain, both from people suffering and people in the medical community. There's a lot of snake and oil to a lot of products out there, but I'm a physician. I'm trained. So I could provide the balance of 'Gosh, we really want this to work, but we need to see results and we need to have the clinical data to back it up,'" said Gozani.
After much trial and error, the Quell was completed, but Gozani said that his company will continue to fine-tune and revise the wearable. He said the the device could be smaller and lighter and could evolve to offer more-personalized chronic-pain solutions. Gozani envisions a time when cloud-stored health data collected by the device could be used to offer more-targeted pain management to the wearer.
"I'm a big advocate to describe chronic-pain management as a toolbox. You have different tools available to you. Clearly medication for many people -- could be anti-inflammatories, could be prescription opioids -- is a useful tool. There are non-technology solutions like yoga and cognitive behavior therapy. But technology has not been a significant player in chronic pain," Gozani explained. "You have TENS devices that I wouldn't call sophisticated technology. With wearable tech and IoT devices you have tremendous potential for tech being a big part of the toolbox. There are a lot of chronic pain apps out there -- some are pretty useless, some are pretty interesting. Tech's place in the toolbox really is a wide open space, and that's where we see a lot of opportunity."
Since the Quell is relatively new, there is little information out there -- beyond NeuroMetrix's own studies -- to verify how effective the device really is. Customer reviews on Amazon for the Quell Wearable Pain Starter Kit are generally positive: 3.3 out of 5 stars from 247 reviews. Mixed with positive experiences like Jennifer's are some complaints about skin rashes from the wearable itself to the electrodes affixed to the band running out too soon and needing to be replaced too often. Some people complain that the pain still hasn't gone away. The problem with devices like the Quell is that chronic pain does not possess a one-size-fits-all solution.
There are many different kinds of pain. A device that helps with arthritis might not necessarily dull another's sciatica. Traditional TENS devices are more tried and tested. A 2015 study published in Pain Management looked at the current state of scholarly evidence of the efficacy of TENS devices. The study discovered that increasingly, researchers are finding TENS devices to be effective for fibromyalgia and spinal cord injury while others have found that users develop a resistance to regular use of the devices, counteracting their effectiveness. Overall, the authors write that these devices have been helpful for treating chronic pain, and high-intensity TENS use has been shown to decrease "post-operative opioid requirements and negative opioid-side effects."
"'FDA cleared' ... does not mean there are any studies supporting effectiveness."
"Many of these devices are marketed as 'FDA cleared,' which means the FDA considers the device to be harmless, but this does not mean there are any studies supporting effectiveness," Edward V. Nunes, MD, professor of psychiatry at Columbia University Medical Center, wrote in an email. "Other common recommendations include physical therapy and physical activity, as well as cognitive behavioral therapy, which do have evidence of being helpful."
Nunes stressed that despite the fact that there is "very little data with respect to these kinds of devices" that aim to help people with opioid-use disorder, it's key to remain open minded to the possibility that they can help.
"I would be open to any device that claimed to help manage pain without medication, since this is an important goal," he added. "But I would want to see the data."