Spurred by the opioid crisis, a once marginalized therapy that relies on electrical stimulation to treat chronic pain is undergoing a renaissance as device makers race to upgrade their products for a wider population of patients.

The companies believe the therapy, known as neuromodulation, can reduce reliance on opioid painkillers, which laid the foundation for a spike in overdose deaths and led to a fierce debate over how best to treat patients with chronic pain. It is also seen as a significant business opportunity, with one research firm predicting that the market for neuromodulation will grow by 15 percent a year, to more than $16 billion by 2024.

Over the past four years, device makers have introduced products that deliver stimulation at different frequencies and levels of intensity, expanding the number and type of patients that may be candidates for neuromodulation. The therapy involves the surgical implantation of a spinal cord stimulator that, when turned on, delivers mild electric pulses to nerve fibers in the spinal cord. The electricity interrupts the pain signals that are carried to the brain, providing relief to patients.

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In addition to improvements in stimulation techniques, device markers are adding wireless bluetooth technology to spinal cord stimulators to allow doctors and patients to adjust the intensity levels in real time; tablets and smartphones are also making it easier to collect and report data on patient progress and outcomes.

“That’s where the field is turning — there’s been a movement to make sure we have validated outcomes that accurately represent what patients are telling us,” said Dr. Mark Bicket, director of the pain fellowship program at Johns Hopkins University. “We have some active studies going on at Hopkins and other places looking at patient function with devices like Apple Watch and other wrist-based measurements.”

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Medtronic sponsors a grant for pain fellows at Johns Hopkins, but Bicket does not receive direct payments from that program.

It would be impractical and incredibly expensive for every chronic pain patient now taking opioids to get these implants. But pain specialists say neuromodulation is part of the solution to alleviating pain and should be considered earlier in the treatment process, instead of as a last resort. Research is underway to determine which types of patients benefit most from the newer devices on the market.

Neuromodulation was the focus of a session at this year’s Consumer Electronics Show in Las Vegas, where device makers gathered for a discussion titled, “The Solution to the Opioid Crisis No One is Talking About.” The largest players in the market participated, including Boston Scientific, Medtronic, Abbott, and Nevro, which began marketing its products in the U.S. in 2015.

“What we are offering and talking about up here is a therapy that can be considered for patients who have chronic pain before they ever get on opioids,” said Dr. David Caraway, Nevro’s chief medical officer. “Or, if they are on opioids, we can get them off opioids or reduce their dose down to safer levels.”

Neuromodulation has been available since the 1960s, but pain specialists say the technology has advanced rapidly in the last few years, driven in part by the need to find alternatives to opioids. The introduction of painkillers such as OxyContin in the late 1990s made it easier and cheaper for doctors to prescribe a pill rather than a surgical implant or other types of therapy. Pain specialists said the cost of neuromodulation ranges from $15,000 to $30,000, depending on the device, the hospital, and the amount of follow-up care provided. Insurance coverage varies by the diagnosis and clinical circumstances, but most insurers pay for it and some are expanding coverage for the newer devices.

During their discussion in Las Vegas, executives for the the device makers emphasized their push to generate evidence to demonstrate the effectiveness and safety of neuromodulation for different categories of patients. Studies have reported substantial pain relief for patients with persistent pain after failed back surgery, while others have recorded similar benefits for patients with leg and other types of back pain, although the research is ongoing.

Researchers are also examining the usefulness of the therapy in treating nerve pain arising from diabetes. And some recent studies have reported that neuromodulation reduced the use of opioids in most patients who received the treatment. But that doesn’t mean it is a panacea.

“The world has a long history of opioid abuse, and I don’t think we’re going to be able to solve this with spinal cord stimulation alone,” said Dr. Sean Nagel, a neurosurgeon at Cleveland Clinic. “It is an option for the right person with a particular kind of pain.”

Doctors cautioned that the therapy must be used carefully, as it carries the risk of complications, such as the migration or fracturing of the implants in the body, which can require additional surgeries. Patients typically try some combination of physical therapy and medication before they become candidates for neuromodulation.

“We are seeing the devices being more applicable to patients … but patients still need to be informed and I think that discussion still needs to happen with each patient to make sure it’s the right step for them,” said Bicket. “The rates of complication are still not insignificant.”

Executives with the device markers said they are stepping up efforts to keep tabs on patients following implantation, both by reaching out to them directly and by using tablets and apps to collect data on the intensity of their pain and activity levels.

“Like monitoring a jet engine over the Atlantic, we can monitor how our devices are performing for the people that are using them,” said Ryan Lakin, vice president of neuromodulation research for Abbott. The company uses Apple products to allow users to adjust their levels of stimulation in response to discomfort.

“When we start to integrate [consumer technologies] in to what we see as these complex medical devices, we can simplify and improve outcomes,” Lakin said.

The ability to follow a patient’s progress not only enables doctors and device makers to adjust stimulation levels, it can also improve the quality of the evidence collected. Assessing the intensity of a patient’s pain has always been hindered by subjectivity. The widespread use of a 1-10 pain score is an imperfect measure, as one person’s 3 might be another person’s 8.

“Unfortunately in chronic pain we have patient-reported outcomes and then a gap” in the measurement system, said Matthew Thomas, vice president of pain stimulation and early interventions at Medtronic. “Creating objective outcome measures, like activity, stress, and sleep, is critical as we go forward and find ways to treat pain.”

  • Try them, neuromodulators. See if they work. It’s likely to be trial and error.
    Like acupuncture. It may work for some people but not likely everyone and will be pretty expensive. I don’t know if insurance or medicare covers it.

    • Hey Steve in MO,

      You sound like a salesman, or you are incredibly naive. Americans will waste millions or possibly billions of dollars “trying them.” That is the point here, profiteering off of misery. The FDA is allowing them to fast track these devices, and we all saw how people died when they fast trqacked the implantable medical devices.
      This country used to have laws about marketing health products, these laws were to protect Americans from fraud in healthcare. To top it all of these sleazy marekters are using the so called opiod epidemic to peddle their wares. It is fact that 80% of opiod overdoses are from heroin or fentanyl, so these devices will have no impact on those deaths. Most communities in the US dont even have basic treament availble for the many who are dying from “opiods.” Actually in many states these deaths are due to a mixture of alcohol, precription drugs that go unamed, and Fentanyl.
      The NIH spends less than 1% of it’s budget on pain research, while refusing to study the impact of psuedo scince, and quackery on American Health. There is zero evidence to support the use of any of these gimmicky devices, just liek there is zero evidence that accupuncture works. Of course there is no research on how industry Gas Lighing is effecting our health either. So people with serious health problems should in your view, just spend a few grand on an experiment, or a device thats sole pupose is to harvest their data, for a skeezy start up. No one is doing any research on how that is negatively effecting healthcare.
      Dont expect the FDA to evaluate any of this to protect Americans, the industry insiders pulling the strings, and the full bore corruption in our administration, view sick americans as a profitable area for exploitation.

      There was a time in America where peddlign this junk would have been a criminal act! Don’t expect the media to fully report the adverse events either. They have been running a long term lie, and information black out on healthcare.

      Maybe salespeple should read up on the infection rates, adn deaths associted with these devices, before putting in their silly two cents!

  • Trust, good that acupuncture works for you. However, it’s cost is prohibitive, requires patient travel excessively and efficacy not proven by any study beyond phase I clinical trials. Furthermore, it’s use has only become a craze by acupuncurrists seeking to “capitalize” off the phony information given to CDC by PROP.

  • i love comments from the peanut gallery. BTW yours trully succeeded in calling for ciring pain in the national pain strategy even though Dr Koh was against curing pain. Medtronic the AMA and big pharma didnt call for curing pain. I succeeded in that regard. Who would like to debate me on curing pain. If you cant take the heat peanut gallery commenters then stay out of the kitchen
    ..

  • Pain care is dead- long live pain care. Deans of medical school are dead and have been dead to people in pain for 200 years. Congress and state govt have been dead too. They suffered from deadening unjustifiable indifferentism and laissez faire. Now they pretend to care by throwing dollars at nih and big pharma and device manufacturers wholl do something about lowering use of opioids- as if the goal of pain care were to lower opioids. So Government has set an atrocious example with their egregious indifferentism towards millions suffering pain. Now bigpharma has also neglected pain and provided underpowered products and complained that govt isnt letting them market products. Device manufacturers also have neglected pain and lack ingenuity, vision and caritas. Who in government, academia or industry- the iron triangle- or should i say three stooges- would like to debate yours truly on pain care. Your vast darkness will be unobscured- as will your lack of sinceritas, caritas, and humilitas. But make my day and debate me in public.

    • edwin . ive enjoyed your critical responsiveness and look forward tobyourcted talk on virtue epistemology and critical literacy. How bout debating me in public. I think my dorsolateral prefrontal cortex and basomedial amygdala is methylated enoughas is my mitochondria cristae density and il6 over il1p But prove me wrong.

    • Dan. Shucks if only i was as wise an inerrant as someone who uses big words like troll. im gonna have to work on my self adaptive evolutionary extrwme learning machine and dynamic system development model to keep up qith your blinkered bliks.

  • Patient selection is critical with regards to neuromodulation devices and medication management for chronic pain. We are still just scratching the surface with regards to comprehensive pain management. The best outcomes in my opinion come about when treatment identifies the truth with regards to diagnosis, and pain impact on mobility, daily activities, emotions, and quality of life. Recommendations for future studies should include treatment/monitoring of these factors as well as co-morbidities and social determinants of health. The opioid crisis is the result of all stakeholders taking a myopic view to pain management, so let’s continue to explore all potential alternatives with more research, imagination and prudence. That would be truly a crusade of genius.

    • Still scratching the surface. One of the first known treatments- trepination- was believed to be used for pain. That was over 8000 years ago. What doesnt medicine get with its cruel unjustifiable medical gaze- that pain doesnt matter because they cant measure it or trust the testimony of people in pain?
      We dont need better selection or monitoring- we dont need more of the failed medical gaze. We need a govt that cares and providers that care. But clearly thru learned incapacity providers are insincere in their care efforts. They have failed to develop comparative relative contribution analysis and adaptive curative treatments for pain. Face the acts poor pain care isnt the natural order of things- it didnt fall from a meteor one day. The failure is in the hearts of govt and providers- fix their hearts and youll fix pain care

    • Mr Fox,
      The only reason an Accupuncture peddler would weigh in on this topic is to do a little advertising and promotion for themselves. Your comment is a bunch of nonsense.

      https://edzardernst.com/2019/01/acupuncture-is-effective-for-chronic-back-pain-if-you-disagree-tell-the-cms/#comment-109269

      CMS is going to try to foist accupuncture on low income patients, even though it is innefective and a waste of time. They chose low back pain because it is subjective, and they can weed out the people with serious spinal injuries, that they misrepresent as low back pain.

    • Dr. Fox,

      I’ve been advocating for Acupuncture for a long time. It works. The MRI allows physicians to understand where Acu is transmitted in the brain. We need to be open-minded and utilizing the MRI for a clear outlook of evidence-based acupuncture.

    • Mr Fox and T Trust!

      There is still no Evidence Based anything for accupuncture. They tried to correlate some nonsese with MRIs but came up with nothing. The NIH allowed them to post accupuncture “studies’ and none of them were conclusive or even done scientifically. Accupuncturists used these unfounded unscientific studies as advertisments for their business. These quacks were peddling “Battlefield Accupuncture” a few years ago, and that was treated as a joke. Needless to say there have been zero “Battlefield Accupuncture” Studies.

  • My wife had a Boston scientific Stimulator implanted about 1 1/2 years ago. She has gotten major relief from her back pain good relief from her acoustics. But her extreme but Doris continues to make her life a struggle. My fear is yes it’s blocking the pain signals to her brain, but over time. If degeneration of discs etc continues and get worse she will. Be unaware of how bad things are getting??????

  • I’m so glad stimulator trial had to be taken out did not work for me, did not take pain away at all . Who knows what could have happened to me if the permanent one would have been installed. Bottom line is even if all of these horrible decisions are reversed, our doctors are not gonna give us back our pain medicine they took away. we are stuck here trying to continue living our lives. NOBODY is going to take the blame!!!! All we can pray for is the future pain patients will not suffer as we do, we can help fight to open the doors and they will someday right the wrong !!

  • I’ve lived in the chronic pain community for 30 years and have heard almost no success stories regarding these devices. They benefit the companies making, selling and marketing them and the doctors, often anesthesiologists, who have pain clinics where they are implanted and where other invasive procedures are done. Touting them as an alternative to opioids is ,wishful thinking since they will never be a treatment for many types of chronic pain such as RA, Fibromyalgia, EDS, Malignant Migraine. And as others have pointed out, prescribed opioid rates have dropped since 2015 and overdose deaths are almost all due to heroin, street fentanyl, benzodiazapines and/or a combination of these. Blaming and targeting compliant pain patients is unacceptable but has been convenient low hanging fruit for the CDC to say they are doing something.

  • I was put on a stimulator a little over a year ago. It’s never worked properly. The rep has tweeked it a few times. Now it only works when I lay down. I agree that the opioid crisis has nothing to do with those with chronic pain. I’m very particular with my meds and take them by the letter. I feel like I was used as a guinea pig for this device that I now have that doesn’t work inserted into my butt/hip.

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