Wearable Over-the-Counter TENS Device Treats Pain in Bed and On the Go

Transcutaneous electrical nerve stimulation (TENS) therapy use low-voltage electric currents to treat pain. Electrodes or mediums for electricity to travel to the body are placed on the site of pain, and the currents block pain receptors from being sent from the nerves to the brain. Usually, the patient will receive a small, battery-operated TENS machine to use at home. TENS therapy can be used to treat both chronic and acute pain, and TENS is most commonly used to treat osteoporosis- or fibromyalgia-related joint, bone, or muscle problems, tendinitis, bursitis, and neck, labor, and cancer pain.
 
NeuroMetrix, a Waltham, Mass.-based bioelectrical and digital medicine company driving innovation to address chronic health conditions including chronic pain and diabetes, debuted Quell, a wearable, over-the-counter (OTC) TENS device, at the 2015 Consumer Electronics Show (CES). The device is worn on the leg and sends neural pulses to the brain that trigger a natural pain relief response in the central nervous system. According to the company, since first launching Quell, almost 200,000 individuals living with chronic pain have experienced its patented neurotechnology. Quell 2.0, the next-generation, 50 percent smaller iteration of the wearable TENS device, was launched at this year’s CES, replete with enhanced features.
 
To gain more insight into how technology can help to curb or eliminate opioid use, I recently spoke with Shai Gozani, M.D., Ph.D., NeuroMetrix’s chairman, president, and CEO. Some of his input is included in the pain management-focused cover story for the March/April issue of ODT, entitled “Pain, Pain, Go Away.” The full extent of Dr. Gozani’s comments are featured here.
 
Sam Brusco: Why is it important for medical technology to be part of a pain management regimen?
 
Dr. Shai Gozani: 100 million Americans have chronic pain. Many are prescribed opioids despite side effects and the potential for addiction, which has contributed to the devastating opioid crisis. There’s a desperate need for non-pharmacological pain treatments. Recent research shows people living with chronic pain feel stigmatized by the opioid crisis and are looking for alternative treatments.1 Pain tech such as Quell has an important role to play in helping people reclaim their life from chronic pain. The opioid epidemic has created new challenges for clinicians and chronic pain patients:
 

• 84 percent of patients believe there is a stigma around opioid use¹
• 42 percent admitted it has impacted how they communicate with their doctor about their pain¹
• 90 percent of chronic pain patients are looking for new treatment option¹

 
Brusco: How does Quell itself work? How does the Quell Relief App enhance the therapy?
 
Dr. Gozani: A Class II medical device, Quell 2.0 is an advanced form of transcutaneous electrical nerve stimulation (TENS). The device is worn on the leg and sends neural pulses to the brain that trigger a natural pain relief response in the central nervous system. Since first launching Quell in 2015, almost 200,000 individuals living with chronic pain have experienced its patented neurotechnology.
Quell 2.0 is powered by the Quell Relief app which allows users to calibrate the device, start/stop therapy, adjust intensity, and track sleep, activity, pain, and gait. It allows for customized therapy dosages, sleep modes, and a variety of other settings. It can even adapt to changes in the local weather, providing user alerts and the option to increase dosage if the weather is predicted to change in a way that affects their pain.

 
Brusco: How does Quell differ from other neurostimulation therapies for chronic pain?
 
Dr. Gozani: Quell is 100 percent drug-free and has been shown in multiple studies to relieve chronic pain. Quell uses high-frequency nerve stimulation to block pain signals in the body. The mechanism of action is thought to be activation of central inhibition and a decrease in central excitation. In a study published in the Journal of Pain Research, 81 percent of Quell users reported an improvement in chronic pain.²
Quell is a more advanced way to treat chronic pain. Like TENS units and implantable spinal stimulators, Quell uses electrical nerve stimulation to provide pain relief. Quell 2.0 is up to 10x more powerful than typical over-the-counter (OTC) TENS devices³. Quell is also the only OTC electrical nerve stimulation device FDA cleared for use while sleeping and can be used during the day when active or at night.
Its intuitive app manages and tracks therapy as well as measurable outcomes such as pain, sleep, and activity. It’s designed for people with a wide range of chronic pain conditions. Quell can even adapt to changes in the local weather, providing user alerts and the option to increase dosage if the weather is predicted to change in a way that affects their pain!
 
Brusco: Why is a wearable solution important for chronic pain patients?
 
Dr. Gozani: Chronic pain affects many people 24/7, making it important for a technology solution to seamlessly fit into their life. Wearable technology, through miniaturization, automation, and user-centric design allows a person living with chronic pain to receive treatment and experience relief whenever they need it, even when on the go or sleeping.
 
Brusco: Are you finding that clinicians, patients, and payors are embracing medical technology as a solution to manage pain?
 
Dr. Gozani: Technology has not been widely used in the past to treat pain, but that is changing. A recent survey showed 90 percent of chronic pain patients are looking for alternatives to opioid medications.¹

 
Brusco: If so, what do you believe convinced them to use the technology over traditional pain management methods?
 
Dr. Gozani: Restrictions on physicians prescribing opioids, but also the fact that people are looking to avoid the side effects associated with prescription pain medications. There is still a challenge shifting people’s mindset from popping another pill to using tech to treat pain.
 
Brusco: If not, what do you believe is necessary to change their opinions?
 
Dr. Gozani: It takes a combination of raising awareness that there are clinically proven technologies, and educating patients that technology can be an effective alternative, with no major side effects.
 
Brusco: What plans are in the future for Quell and/or other NeuroMetrix pain management technologies? 
 
Dr. Gozani: We believe technology can empower people to reclaim their lives from chronic diseases. Through our long-standing history and clinical expertise, we understand that by tapping into the power of the nervous system, we can affect disease without the side effects of drugs. Our mission is to improve health through technology – by investing in meaningful innovation and gathering data, we can use these insights to transform medicine.
We are looking to bring even more personalization to Quell and later this year expect to upgrade the firmware on Quell 2.0. This upgrade will enable Quell to deliver on the promise of AI. These algorithms are derived from the application of machine learning to millions of data points from over 70,000 chronic pain suffers in the Quell Health Cloud. The process evaluates demographics, health conditions, pain levels and characteristics, device utilization and objective measures of sleep, activity, and gait from Quell users to power truly personalized treatment. Quell is already smart enough to adjust a user’s therapy based on manual intensity changes, body position, and sleep movements. With this upgrade, setup and use will be even more precise.
 
References
¹ NeuroMetrix. (2018). Flipping the Script: Living with Chronic Pain amid the Opioid Epidemic.
² Journal of Pain Research 2016;(9):469-479. Based on 60 days of product use. Results may vary.
³ Comparison to leading OTC TENS devices, based on IRI data. Max sustained energy when used as directed