Have pain? For many years, the answer has been to take a pill. But the opioid epidemic has shown the limitations — dangers — of sticking to just pharmacological approaches to one of the most common, fearsome health problems that people have, especially when the pain settles in as a chronic problem. Clinicians and entrepreneurs — and some patients — have a growing interest in nonpill approaches to pain treatment that use device technologies.
Multiple virtual reality (VR) solutions now available have been effective in helping patients cope with acute pain. VR can be so absorbing that it takes people’s minds off their pain. For instance, VR applications can help women manage labor pains and even help with the sharp pain caused by removing a bandage. But chronic pain is complex and VR applications to help with it are still very much under development.
“Acute pain has been proved many times over to be treated very well through VR via distraction therapy,” says Sandra Marshall, a senior associate at the consulting firm Booz Allen Hamilton, who focuses on VR and other augmented reality technologies. “I’ll be curious to see where chronic pain goes in the VR space. It’s a newer application for VR technology, and, as chronic pain manifests itself differently in everyone, what might work for one individual might not work for the next,” she says.
Marshall says at-home mindfulness, meditation and breathing treatments coupled with VR in the office could help patients with pain. “There is a difference between a wellness app and a clinically prescribed pain management application. If people want to get a wellness app, they can easily get one and use that in the comfort of their home,” she says. “But if they want to use a clinical app specific to treating chronic pain, then it has to be prescribed and monitored by their doctor. Chronic pain therapy can be used both in a clinical setting and at home through a prescription service. That being said, acute pain management is more often used in just a clinical setting.”
For now, Marshall says, practitioners should implement VR in a pain management plan on a case-by-case basis. The devices are getting smaller, although most models are still about the size of a snorkeling mask, and they’re becoming more affordable. VR headsets on Amazon are priced as low as $35. Treating pain with VR “really has to be tailored to the patient, and we are still exploring what types of therapies we can offer in the form of VR treatment that will best help individuals suffering from chronic pain,” says Marshall. She also notes that gathering and analyzing data about chronic pain will help with the development of VR techniques.
Spinal cord stimulators are devices that involve placing electrodes between the spinal cord and the vertebrae in the epidural space. Why they relieve pain isn’t completely understood, but researchers believe that the electrical impulses modulate dysregulated pain pathways. The impulses may also dilate blood vessels, thereby relieving ischemic pain. In this country, the most common indication is for chronic pain after failed back surgery. In Europe, practitioners use spinal stimulators to treat peripheral vascular disease. Yet studies of the efficacy of spinal cord stimulators have produced mixed results. Calculations of how many patients suffer complications vary greatly, from small minority to as many as 40%. Lead migration, when the electrodes move out of place, is one of the most common complications.
Medtronic, Boston Scientific and other large medical device companies offer spinal stimulators. One of the newest is Abbott’s Proclaim XR recharge-free device, which the FDA approved in September 2019. A key selling point is that it works at low doses, so the battery can go without recharging for 10 years, according to Abbott.
“Our device has a lot of unique aspects to it that are very patient centric,” notes Allen Burton, M.D., medical director for neuromodulation at Abbott. The stimulator works with Bluetooth and Apple iOS, allowing patients to fine-tune the settings within limits set by the physician. “The device controls patients’ pain and brings their symptoms down to a very tolerable level. The patient goes on about their life, and they don’t have to spend a lot of time making those subtle adjustments with the device,” he says.
Burton says the Proclaim XR is for patients with chronic pain who are stuck in a “chronic care cycle where they’re having a terrible quality of life and consuming lots of healthcare resources.” He adds, “We have studied and found that psychologically, it is very advantageous for chronically ill patients to get control of their chronic symptoms but not have constant reminders that they have a chronic illness. We’ve really taken time to engineer this in a very patient-centered way to achieve those goals.”
Auricular vagus nerve stimulator
The vagus nerve, the longest cranial nerve, travels down the body from the brainstem to the pharynx, larynx, trachea, heart and the entire gastrointestinal tract. But it also has two branches that go out to the auricle, or the external part of the ear.
Transcutaneous auricular vagus nerve stimulators take advantage of this structure and the access it provides to the vagus nerve. They work by stimulating the vagus nerve with electrodes placed on the auricle. The first auricular nerve stimulator to get the go ahead from the FDA was approved for acupuncture-like treatment in 2014.
The IB-Stim device is a version of a transcutaneous auricular vagus nerve stimulator for the treatment of pain from irritable bowel syndrome. The FDA approved it last year for use in patients 11 to 18 years old. Innovative Health Solutions, a device company headquartered in Versailles, Indiana, markets IB-Stim and a similar device, sold as NSS-2 Bridge, for treating the symptoms of opioid withdrawal.
Katja K. Kovacic, M.D., a pediatric gastroenterologist at Children’s Hospital of Wisconsin in Milwaukee, says patients wear the IB-Stim device for five days straight, day and night, and then take it off for two days before seeing their doctor the following week for evaluation. She adds that depending on individual needs, a patient can use the device on this schedule for several months. Transcutaneous auricular vagus nerve stimulators are an attractive choice for younger people because many parents, as well as the patients themselves, don’t want to involve strong pain medications, observes Kovacic. Practitioners have so far treated more than 500 patients with the device, according to Kovacic.
Donna Marbury is a writer in Columbus, Ohio.