FDA Wants More Medical Devices to Treat Pain

By Pat Anson, Editor

The deadline is fast approaching for companies to enter the Food and Drug Administration’s medical device challenge, a contest of sorts aimed at stimulating the development of new technologies to treat pain and prevent opioid abuse.

The FDA announced the innovation program in May and the deadline for applications is September 30.  Medical devices in any state of development – including those already on the market – are eligible for submission.

“Medical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in tackling the opioid crisis,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Better medical devices that can effectively address local pain syndromes can, in some cases, supplant the use of systemic opioids. This can help reduce overall use of opioids.”

Devices that are found to innovative will receive a “breakthrough device” designation from the FDA – similar to the “fast track” designation that the agency gives to promising pharmaceutical drugs. With fewer regulatory hurdles, companies can bring their products to the market sooner.

“I think its great. It’s exactly the kind of thing that’s needed,” said Shai Gozani, MD, President and CEO of NeuroMetrix, the maker of Quell. “It’s a little unclear what exactly they’ll offer to the winners. It looks like they’ll give you intensive help for a period of time to climb the regulatory pathway."

In recent years, the FDA has granted or approved over 200 devices related to the treatment and management of pain. One of them was Quell – a nerve stimulation device worn just below the knee – that relieves pain without drugs in patients suffering from arthritis, neuropathy, fibromyalgia and other chronic conditions. Since its release in 2015, over 150,000 Quell devices have been shipped.

This week NeuroMetrix released Quell 2.0 – an updated version that is half the size and weight. Customers wanted a smaller device to make it easier and more comfortable to wear throughout the day and while sleeping.



“The feedback we got from customers over the past three years is that the single most valuable way to improve the product was to make it smaller,” said Gozani.  “Quell 2.0 is half the size, without any sacrifice in the electric stimulation characteristics. In fact, we increased the power by 20 percent, which allows us to stretch the range of patients that can be treated even further.”    

Gozani told PNN there is no single disorder or medical condition that Quell works best on -– it depends more on the individual, who may live with a variety of different conditions.

“Most people who use our product typically have five sites of pain and three or four medical conditions. It’s not like you can say that person has diabetes or that person has lower back pain or knee osteoarthritis. It all overlaps,” he said. “Surprisingly, we’ve seen that it works better in older adults than in younger.”

PNN columnist Jennifer Kilgore, who lives with chronic back pain, has used Quell every day for three years. She appears below in this promotional video for Quell.

A major difference between Quell 2.0 and the older “classic” Quell is that the new version is operated entirely by an app. It adjusts therapy automatically based on body position and doesn’t need to be turned on and off.

Quell is sold over-the-counter, does not require a prescription and is not usually covered by insurance. Quell 2.0 sells for $299, while the classic Quell is still available at $249. There’s a 60-day money back guarantee for both.

For more information, click here.

A Third of Pain Patients Have Stopped Using Rx Opioids

By Pat Anson, Editor

Over a third of pain patients (34%) have stopped taking opioid medications because their doctor is no longer willing to prescribe them, according to a large new survey of American adults living with chronic pain.

Eight out of ten patients (84%) say there is an unfair stigma associated with chronic pain, and half said they have lied about or hidden their use of opioid painkillers from others.

“The rise of the opioid epidemic has had a significant impact on those living with chronic pain, and oftentimes the voice of this population has gotten lost. We wanted to shine some light on the experiences of chronic pain sufferers with this research,” said Shai Gozani, PhD, president and CEO of NeuroMetrix, which commissioned the survey.

NeuroMetrix is the creator of Quell, a wearable medical device that uses neurostimulation to relieve chronic pain. The company hired the market research firm of Vanson Bourne to interview 1,500 Americans aged 25 and older, who were suffering from chronic pain for at least three months. An equal number of men and women participated.

The interviews were conducted online in early 2018 -- two years after the Centers for Disease Control and Prevention released new guidelines that discourage the prescribing of opioids for chronic pain. Although voluntary and only intended for primary care physicians, the guidelines have been widely adopted by insurers, regulators and providers throughout  the U.S. healthcare system.

The survey found that most pain patients are cautious about their use of opioids. Sixty-one percent are worried about addiction, a little over half (51%) said they only take opioids when necessary, and 42% don't like their side effects.

The stigma associated with opioids impacts how some patients communicate with their doctors. One out of five (20%) downplay the level of their pain and 13% said they are more cautious when speaking with their doctor. Only 9% of patients said they emphasize their pain level.

Most patients want to try pain therapies besides opioids. Nine out of ten said they are actively looking for new treatment options and most had tried at least one alternative, non-pharmacological therapy.  


Most Widely Used Alternative Therapies

  • 65% Physical therapy
  • 65% Lotions, rubs and patches
  • 44% Over-the-counter TENS
  • 33% Doctor prescribed TENS
  • 28% Yoga, pilates, meditation
  • 21% Acupuncture
  • 16% Medical marijuana
  • 16% Cognitive behavioral therapy
  • 15% Surgery, implantable devices

The two most common reasons for pain patients to seek alternative treatments is because they don't like the side effects of prescription drugs (43%) and they prefer to treat pain without medication (39%). A majority (59%) don't believe their doctor is completely informed of treatment options outside of prescription drugs.

“These results underscore the need for more research and treatment modalities to support those living with chronic pain, as well as a joint effort among care providers, innovators, government stakeholders and patients to expand the goals of pain treatment," said Gozani.

"If we shift focus to making the end goal of pain treatment about decreasing suffering and disability rather than exclusively pain intensity, we may open ourselves to new possibilities and treatments that will empower those with chronic pain to find relief and gain greater control over their lives.”

You can read the full report, “Flipping the Script: Living with Chronic Pain amid the Opioid Crisis” by clicking here.

4 Alternative Therapies That Help Lower Pain Levels

By Barby Ingle, Columnist

This is the 11th month of my series on alternative therapies for chronic pain management. As I have stressed month after month, each of us is different, even if we are living with the same diseases. No one treatment works for everyone. We must find creative and effective ways to get our pain levels lower.

This month I am shining a spotlight on four treatments that may help you or your loved one in chronic pain: Quell, radiofrequency ablations, reflexology and sonopuncture, also known as sound therapy. I have tried all four of these treatments with varying degrees of success.


Quell is a wearable medical device that uses electric nerve stimulation to deliver relief from chronic pain. I have tried this device and passed it on to some of my friends with back, arthritis, nerve, leg and foot pain. For me, the relief was not as significant as I had hoped, but I have a friend who has used it daily for a year and swears that it helps her leg pain.

NeuroMetrix, the maker of Quell, designed the device to be worn on the upper calf muscle. It was small enough to wear under my sweatpants and not too big or bulky to get in the way. The device sends neural pulses through the central nervous system to the brain to trigger the body’s own pain blockers. It has a variety of stimulation patterns and sleep modes, and the intensity of therapy can be adjusted through an app.

If you have tried a TENS unit or Calmare and gotten some relief, this might be a successful tool to help you manage your pain. A Quell starter kit costs $249. Each unit comes with the device, leg band, two electrodes and charging cords. You have to replace the electrodes about every two weeks with normal use, but the battery is rechargeable.

I believe Quell is an option that is worth looking into and they have a 60-day moneyback guarantee if it doesn’t help you.

image courtesy neurometrix

image courtesy neurometrix

Radiofrequency Ablation

Radiofrequency ablation (RFA) uses heat to stop the transmission of pain. Radiofrequency waves “ablate” or burn the nerve that is causing the pain. The nerve stops sending pain signals until it regrows and heals from the ablation. RFA is most commonly used to treat chronic pain caused by arthritis and peripheral nerve pain.

I had RFA procedures 36 times from 2005 to 2008. It never took my pain away but did lower my pain levels and helped take the edge off. The doctor performed them on the ganglion nerve bundle in my neck. My insurance covered the procedures and it was helpful in keeping the need for high dose pain medications down.

RFA procedures are typically done in an outpatient setting under local anesthetics or conscious sedation anesthesia. The procedure is done under guidance imaging, like a CT scan or by ultrasound machine, by an interventional pain specialist.

RFA is said to help in treating the desired nerve without causing significant collateral damage to the tissue around where the ablation is performed. Still, a patient should take precautions and understand that the ablation can cause trauma or injury to the body, and conditions such as CRPS or arachnoiditis can be exacerbated long-term with this treatment.

When I was having RFA, it was one of the only options I had access to. Once less invasive options became available to me, I opted to stop these and nerve blocks all together.


Reflexology involves the application of pressure to the feet and hands with thumb, finger, and hand techniques. Reflexology is very relaxing and calming for me but there is no consensus among reflexologists about how it works, and some technicians are better at it than others.

Practitioners believe that there are specific areas in the hands and feet that correspond with organs in the “zones” of the body. There are five zones on each half of the body that reflexologists work on. In theory, they help stimulate blood flow and better blood flow leads to better working organs and muscles

The research on reflexology is skimpy and it has not been proven as an effective treatment for any medical condition.  It’s more of an approach to health lifestyle living, which can be of benefit to pain patients. This can help lower blood pressure and relax a pained body by taking the edge off.

I can say reflexology did seem to help with my constipation issues, but I was doing it while taking OTC and prescription strength medications, as well as stretching and stomach massages.



Sonopuncture is also known as vibrational or sound therapy. The idea behind it is similar to that of acupuncture, although instead of needles they use sound waves. Sonopuncture practitioners believe that sound waves stimulate the body into healing.

Sonopuncture was recently highlighted on an episode of “Keeping Up with the Kardashians” when Kendall Jenner was going through some anxiety challenges. I have used sound therapy myself to help with the stress of living with chronic pain and find it relaxing and mentally therapeutic.

Typically, the patient lays down in a comfortable position on the floor or a massage table. The practitioner will used tools like a tuning fork, glass bowls, chimes, metal or electronic devices that emit harmonic sounds or vibrations on acupressure points for about a minute each.

This is a noninvasive therapy and is suitable for all ages. Since no needles are involved, it could be seen as an alternative to acupuncture. With one in four patients afraid of needles, this could be a great way to calm your nerves and mind to help manage the challenges of living with chronic pain.

If you are considering any of these alternative treatments, I encourage you to first talk with a medical professional who is familiar with your past and present care and can help you discover what would be appropriate for you.

Barby Ingle.jpg

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Quell Relieves Back Pain Without Medication

By Pat Anson, Editor

Like many people who suffer from chronic back pain, Greg Watson has tried a lot of different treatments, including physical therapy, soft tissue manipulation, chiropractic adjustments, trigger point injections and dry needling.

“I did trigger point injections with really big needles,” says Watson, whose back was broken in four places when his bike was hit by a car in 2011. “A lot of interesting ways of relieving pain by triggering an even bigger pain. Some of those things would work temporarily.”

Watson spent five days in the hospital after the accident, where he was “pumped full of morphine.” When he was finally released and sent home, the 45-year old Watson was determined to avoid taking more pain medication. That meant trying all of those alternative therapies, with little success, and living for years with intermittent pain that sometimes reached a 6 or 7 on the pain scale.

A friend recommended that Watson try Quell, a battery powered medical device worn below the knee that uses electric nerve stimulation to relieve pain throughout the body -- a therapy known as neuromodulation.

“I felt it and noticed something right away,” says Watson. “It feels a little bit like pins and needles, and it kind of comes in little waves or pulses. Very low amounts of electricity coming into you.”

It took a couple of days for Watson to feel some pain relief. The biggest improvement he noticed was that he slept better.  

“I would go home and put it on for a few hours and then be able to get a full night’s sleep without having to wake up with leg discomfort in the middle of the night,” said Watson, a city planner in Boston who is an avid runner and bicyclist.

neurometrix image

neurometrix image

On bad pain days, Watson will wear the Quell device while sleeping or at work. But mostly he just wears it for a few hours at a time. Watson has found that he’s often able the get through an entire day without even thinking about his pain. 

“There are some days I get a bigger uptick in the amount of pain that comes from that old injury site. But when that’s the case, I just up-ramp the use of it a little more.”

Quell is made by NeuroMetrix (NASDAQ: NURO), which recently won approval for the device to be sold in the Europe Union.

It’s been available in the U.S. since the summer of 2015 and is FDA approved for the treatment of chronic pain.

Quell can be purchased without a prescription, but is not covered by insurance and costs $249 through the company’s website or on Amazon. 

PNN columnist Jennifer Kain Kilgore says Quell “worked brilliantly” in relieving her chronic neck and back pain.

But readers have had mixed results with the device.

“Very expensive, wasn't covered under my Medicare insurance. I tried it for a couple of weeks and simply didn't receive ANY pain relief for my low back and neck. None. I am very disappointed,” wrote one woman.

“I have been using Quell for a month now. I use it mainly at night for the pain that I experience in my hips and legs that keeps me from sleeping,” wrote Pam. “It actually has helped me to ditch the sleeping pills. It helps me fall asleep. I am elated.”

“I am on day 18 of my Quell device. It has eliminated the pain in my knees. No more Bengay, Australian Dream or Blue Emu Cream needed. The pain in my feet and hips has diminished greatly,” said Beth Flood. “It is not perfect, it is not a complete answer, but for what it does and the relief it has offered, it is well worth buying.”

NeuroMetrix recently announced that it was conducting a small clinical study of Quell in 60 adults with chronic low back pain at the Brigham and Women’s Hospital Pain Management Center. The three month study will compare a group of patients using Quell to patients using their “treatment-as-usual.” Participants in both groups will use a smartphone app developed by the Pain Management Center to help them document and manage their pain.

“This study will analyze the potential for Quell to reduce pain and improve quality of life in people suffering from chronic low back pain. We look forward to learning a great deal from this study,” said Shai Gozani, MD, President and CEO of NeuroMetrix in a news release.

In previous small studies of Quell in patients with arthritis, diabetic neuropathy, sciatica or fibromyalgia, over 80 percent said the device relieved their chronic pain and improved their overall health. The largest measured changes were in pain relief, along with improved sleep, general activity and walking ability.

Over two-thirds of the patients said Quell also reduced the amount of pain medication they were taking. That’s an important consideration for Greg Watson.

“Especially if you’re looking to avoid medication. That’s the absolutely most appealing thing about it to me,” he says.

Chronic Pain? There’s an App for That

By Pat Anson, Editor

Smartphones have revolutionized the way we communicate. And they are fast becoming a tool in the treatment of chronic pain.

Wearable medical devices linked to smartphones can not only do simple things like track your pulse and blood pressure, they can help relieve some types of chronic pain without the use of drugs. Several of these new medical devices are being showcased next month at the 2016 International Consumer Electronics Show (CES) January 6-9 in Las Vegas.

One device making its debut at the trade show is the iTens, the first FDA-cleared wireless TENS device that works via an iPhone or Android based app.

Transcutaneous Electrical Nerve Stimulation (TENS) has been used for decades to relieve pain by using electrical stimulation to block or mask pain signals. But the old TENS units typically come with many wires, are anything but portable, and could only be used for limited 30-minute periods.

images courtesy of itens

images courtesy of itens

“The iTENS device was created for people who are in need of a portable, convenient method of pain management that doesn't involve taking prescription medication,” says iTENS CEO Joshua Lefkovitz. “We designed the iTENS to be thin, flexible, discreet, and easy to operate with the push of a button from the iTENS app.”

The iTens uses peel ‘n’ stick gel pads that can be directly applied to painful areas. The pads are powered by a lithium-ion rechargeable battery that can provides relief for up to 24 hours.  During that time, the iTENS app measures a user’s pain scale, tracks their results, and charts their progress.

“We’ve got the first clearance from the FDA that has a Bluetooth enabled app,” Lefkowitz told Pain News Network. “There are other wireless TENS devices out there, but none of them are app-enabled.

“It’s really cool, because with an app you can roll in new settings. We’ve got body part settings, condition-specific settings, and you’ve got manual settings so you can pre-program whatever settings you want.”

The iTens device will become commercially available in March for $89.95. No prescription is needed and the device is “FDA-cleared” – meaning the Food and Drug Administration has approved iTens’ safety, but not necessarily its efficacy.

Device makers have a huge advantage over pharmaceutical companies because they are held to a lower regulatory standard and often can get fast track approval from the FDA without any clinical studies – as long as the new device is substantially the same as an old device already on the market.

One disadvantage to that approach is that without full FDA approval, few insurance companies are likely to offer reimbursement for a wearable medical device and physicians are less likely to recommend them.

That conundrum will be addressed at the CES trade show in a panel discussion titled “Roadmap to FDA Approval.” One of the speakers is Shai Gozani, President and CEO of NeuroMetrix Inc., maker of the Quell pain relief device, a neurostimulator worn below the knee

“If wearable technology is going to achieve its tremendous potential it must move beyond wellness to tackling fundamental health problems such as chronic pain, diabetes, and heart disease. This necessarily implies regulation by the FDA,” said Gozani. “I hope this panel will start to demystify the regulatory process and encourage technology companies to embrace the opportunity of consumer medical technology.”

The FDA issued guidance earlier this year on the types of apps that would be subject to regulatory review. The agency said it was not trying to stifle innovation and the regulations would only apply to a  “small subset of mobile apps that are medical devices and present a greater risk to patients if they do not work as intended."

The goal is not to regulate “wellness” apps that keep track of things like fitness and nutrition, but apps that make specific claims about diseases and conditions.

According to industry estimates, by 2018 over half of the world’s 3.4 billion smartphone and tablet users will have downloaded mobile health applications

New Wearable Devices for Chronic Pain

By Pat Anson, Editor

With opioid pain medications becoming harder to get and many patients looking for safer alternatives with fewer side effects, a growing number of companies are offering wearable “electrotherapy” devices for pain relief.

There’s the Cefaly headband for migraines, ActiPatch for sore muscles, AcuKnee for osteoarthritis, and the Quell nerve stimulator, which is designed to treat a range of chronic pain conditions. All are part of a fast growing $2.8 billion market for wearable medical devices.

“There’s a big problem brewing on the horizon. And that is the pain medications are being removed from the market, slowly but surely,” says Phillip Muccio, President and founder of Axiobionics, which has been making customized electrotherapy devices for 20 years.

“Electrical stimulation has a way of reaching into the body and interacting and coordinating what happens to the body. That’s why it a fascinating area of medicine because not a lot of things will do that, especially non-invasively and non-pharmacologically.”

Most of the new devices use a form of electrical stimulation to block or mask pain signals – a technique developed decades ago known as Transcutaneous Electric Nerve Stimulation (TENS).

Unlike the old TENS units, which are typically used for about 30 minutes, wearable devices are designed to be worn for several hours at a time or even while sleeping.

image courtesy of axiobionics

image courtesy of axiobionics

“TENS is like a short acting opioid. It’s basically only effective when it’s on,” said Shai Gozani, MD, President and CEO of Neurometrix. “If you’re going to deal with chronic pain, you have to have a wearable, chronically usable device, because pain can be two hours a day or it could be 24 hours a day. TENS devices historically haven’t been designed at all for wear-ability or continuous use.”

Neurometrix recently introduced Quell, an electrotherapy device that Gozani compares to a spinal cord stimulator. But instead of being surgically implanted near the spine like a stimulator, Quell is worn externally on the upper calf below the knee.

image courtesy of neurometrix

image courtesy of neurometrix

“We really look at spinal cord stimulation as the model. We’re trying to make that available but in a non-invasive, wearable way -- versus TENS devices which are really intended for local muscle stimulation. We don’t stimulate the muscles, we stimulate the nerve alone,” Gozani told Pain News Network.

“The upper calf has a lot of nerves. It’s comfortable. It’s discrete. So it meets the requirement to have a large segment of nerves to stimulate, but it’s also highly usable from a wear-ability perspective.”

A small study recently conducted by Neurometrix found that over 80% of Quell users had a significant reduction in pain and two-thirds were able to reduce the amount of pain medication they were taking.  Participants in the study had several different types of of chronic pain, including fibromyalgia, sciatica, neuropathy and arthritis.

When it comes to clinical studies, medical device makers have a clear advantage over pharmaceutical companies, which often have to spend years and tens of millions of dollars proving the safety and effectiveness of their drugs before they’re approved by the Food and Drug Administration. Device makers are held to a lower regulatory standard.

“Devices are approved by FDA basically for safety and not necessarily for efficacy. It’s a lot easier to demonstrate that with a device than if you have to demonstrate a new drug. You basically run one study or two and show that nobody got electrocuted by a TENS unit and you’re good to go,” said Bob Twillman, PhD, Executive Director of the American Academy of Pain Management.

Device makers can even get fast track approval from the FDA without any clinical studies -- if they say a new device is substantially equivalent to an older device already on the market.  Quell, for example, was given clearance by the FDA because of its similarity to Sensus, another Neurometrix device that's worn below the knee for pain relief.

A significant disadvantage for device makers is that most are not covered by public or private health insurers – meaning patients have to pay for them out of pocket. Three years ago, Medicare stopped covering TENS for low back pain, saying the technology was “not reasonable and necessary.”

The lack of reimbursement also makes many doctors unwilling to prescribe wearable devices and unfamiliar with the technology behind them, which stifles innovation.  For that reason, Neurometrix took an unconventional path and made Quell available without a prescription – bypassing insurers and doctors so it could market directly to consumers for $249 a unit.

“We thought it was imperative to get it over the counter. We wanted to make sure it was accessible to patients," said Gozani. "Wear-ability changes everything. Wear-ability is the game changer in terms of optimizing pain relief. I think it's huge."

Quell Device Relieves Variety of Pain Conditions

By Pat Anson, Editor

A new medical device that uses electrical nerve stimulation was effective in managing chronic pain in patients suffering from arthritis, neuropathy, fibromyalgia and other conditions, according to a small clinical study conducted by NeuroMetrix (NASDAQ: NURO), the device’s manufacturer.

Pain News Network recently featured the Quell Wearable Pain Relief device in a column by J.W. Kain, who reported that Quell “worked brilliantly” in relieving her chronic neck and back pain.

Eighty eight people were enrolled in a 60-day trial of Quell. All had chronic pain for at least year and nearly a quarter had more than 15 years of pain. Participants had “complex medical histories” with arthritis (61%), diabetic nerve pain (40%), sciatica (27%), and fibromyalgia (26%) as the most common conditions.

Over 80 percent of the participants said Quell relieved their chronic pain and improved their overall health. The largest measured changes were in pain relief, along with improved sleep, general activity, and walking ability.

Over two-thirds of the patients said Quell also reduced the amount of pain medication they were taking

image courtesy of neurometrix

image courtesy of neurometrix

"We are pleased with these results. They represent the first formal evaluation of self-administered wearable intensive nerve stimulation. Quell provided substantial pain relief and improvement in quality of life measures,” said Shai N. Gozani, MD, President and CEO of NeuroMetrix.

“We were not surprised that two-thirds of the subjects reduced their use of pain medications, as we have consistently received this anecdotal feedback from Quell users over the past several months.”

Quell is available over-the-counter and does not require a prescription. It relieves pain by using electric stimulation to “mask” pain signals before they reach brain, much like a TENS unit.  The device, which costs $249, is lightweight and designed to be worn over the upper calf during the day or night.

The marketing of Quell for the treatment of chronic pain was approved by the Food and Drug Administration in 2014, but NeuroMatrix did not begin shipping the device to healthcare providers until this summer. It is also available through the company’s website.

A study abstract, “Treatment of Chronic Pain with a Novel Wearable Transcutaneous Electrical Nerve Stimulator,” has been accepted for poster presentation at the annual PAINWeek conference next month in Las Vegas.