In 2014 radio producer Coy Dean was at a promotional event in Greenville, North Carolina, when he had a stroke. The 48-year-old couldn't move the left side of his body, and even as he started to recover, his joints were painful, especially his shoulder.
"I play ball, so I was used to pain, but this was a whole other type of pain," Dean said. He couldn't lift his left arm, and he was sleeping poorly because the pain would wake him every time he moved. His doctor prescribed painkillers, to which Dean says he became addicted, popping pills every 45 minutes. He once even broke the top of the bottle to get to the pills faster, he said.
Then Dean heard about a clinical trial for a device called the SPRINT Peripheral Nerve Stimulation (PNS) System, intended to reduce his shoulder pain without drugs. It took his new doctor only a few minutes to slip the thin wire into his arm and another few seconds to calibrate the small patch that controls it. When the device was on, it felt like a massage to his muscles, he said. After a few months Dean's shoulder pain evaporated. He said he still has morning stiffness in his shoulder and he still takes aspirin for the pain from his other joints, but he can now drink a cup of coffee with his left hand with ease.
The SPRINT PNS device is one of a growing class of FDA-approved devices that relieve chronic pain. They have fewer side effects than drugs and, if used in conjunction with other treatments, such as over-the-counter pain treatments and physical therapy, can eliminate patients' pain altogether. If their popularity continues among doctors and patients, the devices may soon become the standard of care to treat chronic pain.
An estimated 100 million Americans are suffering from chronic pain — pain that lasts more than three months and is caused by diseases such as arthritis or fibromyalgia, a remnant of an injury from an accident or surgery or from an unknown source.
In the past, doctors could only suggest that patients undergo physical therapy or cognitive-behavioral therapy to help them deal with their pain. For some patients, those techniques don't provide sufficient relief, so doctors often turn to opiate painkillers, which can cause addiction and long-term health problems, such as insomnia, digestive issues and even increased sensitivity to pain.
Scientists and entrepreneurs saw an opportunity in the $635 billion pain market to create an alternative in the form of devices. "Pain specialists are looking for new solutions to treat pain, for alternatives to opioids and to more invasive and expensive surgeries," said Maria Bennett, president, CEO and founder of SPR Therapeutics, the company that makes the SPRINT device that helped relieve Dean's shoulder pain.
The devices are coming to market now because the science and engineering are only recently advanced enough for this to be possible: "The technology wasn't available in the past, because the electronics weren't able to be made small enough," said Laura Perryman, the chairman and CEO of Stimwave, a company that manufactures a tiny implantable device to treat chronic pain, which was approved by the FDA in March. Thanks to technological advances in the cellphone industry, electronics in general are smaller and more sophisticated, she added, and more affordable.
Many of these devices are designed to specifically treat peripheral pain — pain in nerves that flow from every part of the body up through the spinal cord and into the brain. Some, such as the SPRINT PNS system, approved by the FDA in July to treat chronic pain in the back and extremities, have threadlike wires that need to be inside the body; the Stimwave device is implanted with a small needle. Others, such as Quell(approved in 2014 for all types of peripheral pain) or Cefaly (approved the same year to prevent migraines), treat pain from outside the body.
Fundamentally, each of these devices works by disrupting the pain signal as they move from nerves throughout the body to the brain. And there are advantages to treating pain this way. The devices are not permanent and often relieve pain after just a few weeks or months of use, with many fewer side effects than opiate painkillers; once the pain subsides, the device is removed.
The devices also don't interfere with most other health issues, which means that few patients are excluded from using them (though there are exceptions — people with pacemakers shouldn't use the SPRINT PNS system, for example). And clinical trials indicate that the devices are quite effective if placed properly, though sometimes patients will use the devices for multiple sessions if the pain comes back after the first round.
Risk and reward
The devices aren't completely without downsides. Since most devices are approved by the FDA, their cost is typically covered by most types of insurance and Medicare, but if someone should have to pay for one out of pocket, they could run tens of thousands of dollars.
The implantable devices run a small risk of infection and usually require that a patient carry a pagerlike gadget around with them; the Stimwave device, for example, is wireless but has an accompanying component that is battery-powered, so patients have to make sure they remember to charge and replace those. Some patients, such as those with pacemakers, are not eligible to use some of the devices, because the electricity involved may cause interference.
But to most patients and practitioners, the benefits of the devices outweigh their detriments. Since it was first available in June, the Stimwave device has been implanted in 500 patients, and demand is growing. "We can't make enough. We're sold out for months at a time. We just added three more manufacturing plants," Perryman said.
As more devices become commercially available, their manufacturers hope that devices will take over a larger part of the market to treat pain. "Our ultimate goal is to become treatment of choice," Bennett said. SPR Therapeutics will make its SPRINT device, the one Dean tried, available early this year. She adds that she hopes devices such as this one will improve the lives of many patients.
— By Alexandra Ossola, special to CNBC.com