Wouldn’t it be great if neurostimulator companies would develop a device to provide pain relief for the extremities…without large battery packs and with an ergonomic-friendly design?
If this is the type of nerve stimulator you’ve been waiting for, the wait is over.
Historically, neurostimulation has involved the spinal cord. Few companies have developed peripheral nerve stimulators, or ones that work outside the spinal cord. The need for stimulators for focal neuropathic pain in the extremity has always been around – with needs varying from post-surgical to post-trauma to resulting from injury or limb amputation.
Peripheral stimulators have previously involved placing wires on or close to nerve in the extremities or elsewhere in the trunk of the body. Often, physicians have had to take equipment designed for use in the spine and offer this solution for patients with pain in other areas with less than ideal results and comfort.
Within the last five to six years, there has been a big push to develop specific stimulator devices for the periphery or extremities of the body. Three device manufacturers, in particular, have worked on these type of nerve stimulators. The good news is that they are in or just past the clinical trial stage for device use with a variety of audiences and/or conditions.
Dr. Chris Gilmore and his work with SPR Therapeutics
As a physician with the Carolina Pain Institute and Center for Clinical Research, Dr. Gilmore has seen the struggle to use nerve stimulators for focal neuropathic pain for many years. He has seen first-hand his patients’ desire for pain treatment that didn’t involve medication and treatment that would be successful enough to allow patients to be more physically active.
Recently, Dr. Gilmore connected with one device manufacturer, SPR Therapeutics, to assist them with clinical trials and serve as a consultant. SPR, like all sponsors of trials, dictated the audience for the trial, and they chose to focus on amputee patients. SPR and another provider of nerve stimulation devices have conducted trials with difference audiences. A third provider is moving forward with a peripheral-use neurostimulator as well.
“Our role is to recruit patients into the study, and in this case, it was amputee patients,“ shared Dr. Gilmore.
“We were also tasked with implanting the devices, recording the data results and then publishing the data once the trial was completed. The sponsor company – in this case, SPR, sent the data to the FDA and then worked to get FDA clearance.”
Dr. Gilmore has conducted four clinical trials with SPR, who got their FDA clearance for their device a year ago. Other trials are ongoing. They are targeting low back pain, post-knee replacement surgery pain and more. There is a post-traumatic headache study just starting in conjunction with Wounded Warriors. The Department of Defense funded a grant for the trial that will work to help vets with severe headaches as a result of IED blasts and other traumatic events that lead to chronic headaches.
An alternative pain management approach
Patients are seeking alternatives to the conventional medical approach to pain management – nerve blocks, radical frequency ablation procedures and medication. Providers are under pressure to limit opiate exposure and dosing. As a result, Dr. Gilmore expects the new stimulators to make a larger impact, especially earlier in the pain treatment process. And many of these stimulators can be implanted in the office with a needle, requiring no surgery or hospital time.
The devices themselves are quite small. Some have no battery that needs to be implanted. The wire is placed in close proximity to the nerve and induces the current through the skin and subsequently to the targeted nerve. Others have a portion of the wire implanted just beneath the skin that exit and connect directly to an external power source. The stimulator can be left in place for a couple of months rather than being permanently implanted.
“What’s great is that we’ve seen patients get carryover pain relief for several months after the device is no longer there,” says Dr. Gilmore.
“Patients are coming off their medications, able to be more active, no longer feel held hostage by their pain. They say they are able to pick up their grandchildren, go to the beach and really, just do things that they used to do but had not in a long time. The stories are really rewarding.”
One patient of Dr. Gilmore’s had a janitorial work-related injury to his extremity. The pain kept him from being able to paint. After the neurostimulator, he could get back to painting again.
How to get access to this new neurostimulator
While all three manufacturers are attempting to get approval for broad-based use, one way to get access to the smaller devices is through a clinical trial. All three companies are doing trials at specific sites around the country. Patients can do a key word search at clinicaltrials.gov to see if there are trials near them that they qualify for.
Another approach is for a patient to speak to his/her primary physician or surgeon to get referred to a pain management provider who does peripheral nerve stimulation. These providers may also get access to the newer, smaller devices.
Dr. Chris Gilmore is a pain physician at the Carolinas Pain Institute and Center for Clinical Research and a Consultant for SPR.