If you have diabetes, you no doubt already know that as many as 50% of diabetic patients suffer the serious complication of diabetic neuropathy. Those with painful diabetic neuropathy can experience conditions that range from tingling or numbness to a burning, excruciating, stabbing or intractable type of pain.
The first step that your diabetes medical specialist will usually focus on is tight glycemic control to manage this condition – using diet, oral medications, or insulin to control blood sugar levels (glucose). They’ll also regularly screen for associated complications. However, providing relief from the pain is a different issue that can be challenging and complicated.
Several prescription drugs are FDA approved for diabetes-related nerve pain, but they don’t work for everyone. Fortunately for those suffering, the Food and Drug Administration (FDA) has approved the use of non-drug, high-frequency spinal cord stimulation (SCS) as an alternative treatment.
A doctor examines foot nerve response of a diabetic neuropathy patient
Treating Painful Diabetic Neuropathy with Spinal Cord Stimulation
Estimates are that there are 2.3 million individuals in the United States whose diabetic neuropathy pain symptoms aren’t manageable with medications. With the FDA approval of spinal cord stimulation for this condition, this untreatable group now has a new potential alternative.
Treatment involves the minimally invasive epidural implantation of a 10 kHz, high frequency spinal cord stimulator device – which delivers mild electrical impulses to the nerves to interrupt pain signals to the brain.
Spinal Cord Stimulation is a well refined therapy which has been in used since 1967, and has grown exponentially with major developments in the 50+ years since. However, the FDA’s announcement represents the first approval of this treatment specifically for diabetic neuropathy pain.
Reducing Potential Drug Interaction Complications
Diabetic neuropathy pain is notoriously difficult to treat. The Mayo Clinic notes that pain-relieving treatments may include anti-seizure drugs such as pregabalin (Lyrica) and Gabapentin (Gralise, Horizant, Neurontin), or antidepressants (to ease nerve pain, even if you aren’t depressed), including tricyclic antidepressants.
Sometimes these two drug classes can be combined. These drugs can also be used along with over-the-counter medications – of course, but only with your doctor’s involvement and recommendations.
The problem is that this drug approach can require a significant amount of medications daily to achieve a meaningful reduction in pain. Coupled with the spectrum of potential side effects, and the need to manage drug-drug interactions, leads to an understanding of why the potential of spinal cord stimulation as an effective non-drug approach, for some, is so compelling.
A Note of Caution
The FDA’s approval is based in part on successful clinical trials, including a 6-month trial published last April in JAMA Neurology by 37 participating physicians and researchers. While this approach is promising, as in all treatments, it is only appropriate for some candidates.
Almost everyone gets acute back pain from time to time. Maybe you did too much yard work, sat in a long car ride or were a little too enthusiastic in a pickup softball game. The end result – you get a backache or get some back pain.
That acute back pain may linger for a few days or few weeks. The good news is that kind of pain almost always goes away. You generally find things that get you by for that short period of time. It might be over-the-counter pain relievers, home remedies such as heat or ice, or maybe see a physical therapist or chiropractor to help you get through it.
Chronic Back Pain
When you have chronic back pain however, you normally will seek out medical professionals. Chronic back pain is pain that just doesn’t go away. You’ve tried all your home remedies and maybe you’ve seen your family doctor a few times. But the pain continues to linger and persist.
Fortunately, there is an extensive range of treatments available ranging from conservative to more aggressive. Starting at the low end of this spectrum are alternatives such as physical therapy, medications, and injection-based treatments, to name a few. And at the top end of the spectrum is spine surgery.
However, what many back pain sufferers and medical professionals often miss are a growing number of pain relief alternatives that sit in the space between conservative treatments and major surgery. And among those alternatives are three classes of neuromodulation therapies: spinal cord stimulation (SCS), dorsal root ganglion stimulation (DRG), and peripheral nerve stimulation (PNS).
These are options that merit consideration when you want to avoid back surgery, or when back surgery has failed to provide the pain relief you are seeking. They also may be appropriate when you doctors haven’t been able to identify the specific musculoskeletal cause of your pain. We’ll take a brief look at each of them here.
Spinal Cord Stimulation (SCS)
A spinal cord stimulator is a medical device that delivers a set of mild electrical currents to disrupt pain signals traveling between the spinal cord and the brain. It is like a pacemaker for chronic pain.
It involves implanting a neurostimulator under the skin along with thin wires called leads. Together they provide pain relief by modifying pain messages before they reach your brain.
Before any permanent stimulator is implanted, a trial procedure is always used to help determine the likelihood that this therapy will work for a patient. This takes place over a 3 to 10 day period where an external stimulator mimics the treatment that would be delivered by the permanent implant.
The level of pain relief stimulation can be adjusted. Depending on the specific spinal cord stimulator, that adjustment can be done by the patient themselves according to when they need it throughout the day, or automatically with some newer technologies.
Both the trial and permanent implantation procedures are usually done on an outpatient basis. This device has over a 50-year track record of use, and in skilled hands, the serious complication rates are very low.
Dorsal Root Ganglion (DRG) Stimulation
Dorsal root ganglion stimulation is another outpatient neurostimulation therapy, similar to traditional spinal cord stimulation. However, rather than placing the electrodes over the spinal cord as in spinal cord stimulation, leads are implanted on the dorsal root ganglion, a cluster of neurons that represent the sensory gate of the spinal cord.
As sensory feedback moves to your brain, it first must pass through the dorsal root ganglion before entering the spinal cord. Thus, when those dorsal root ganglion neurons are properly stimulated, they can modify pain messages before they move to the spinal cord and other areas of the central nervous system.
Also, like spinal cord stimulation, dorsal root ganglion stimulation involves an initial trial to ensure the therapy is likely to be effective. Then the system is implanted under the skin during an outpatient procedure.
Dorsal root ganglion stimulation has number of advantages in appropriate situations. First, it can be targeted in a much more refined way than spinal cord stimulation and uses only 10 percent of the energy that spinal cord stimulation uses, leading to far longer battery life.
In addition, the leads are less likely to shift in comparison with spinal cord stimulation (although some surgeons are far better than others in how they anchor spinal cord stimulation leads to minimize slippage). And finally, given anatomical realities, patients receive the same pain relief whether laying down, standing, sitting, or walking – where the level of stimulation varies for spinal cord stimulation patients as they shift their position.
Peripheral Nerve Stimulation (PNS)
Peripheral nerve simulators work much like spinal cord simulators, except that we send the mild electrical currents directly to nerves outside of the spinal cord. Peripheral nerves run from your spinal cord to the limbs or organs in your body. Thus, if you have joint pain, a peripheral nerve stimulator would be localized directly at the joint where pain is being experienced.
Recently, a new generation of peripheral nerve stimulation devices has been developed. These new devices allow external pulse generators to transmit impulses wirelessly to the implanted electrode, and their implantation is significantly less invasive. Some devices and therapies are designed so that there is no permanent implantation necessary.
Chronic Back Pain Relief Alternatives at Main Line Spine
Main Line Spine’s team includes some of the nation’s leading experts in spinal cord stimulation, dorsal root ganglion stimulation and peripheral nerve stimulation medical technologies. These treatments, when combined with our multifaceted and compassionate care, deliver a high level of pain relief for our patients.
Jeffery Rowe, MD, is a physical medicine and rehabilitation physician, also known as a physiatrist, with a subspecialty in pain medicine. He practices at Main Line Spine and specializes in minimally invasive interventional spine surgeries.
In this Q&A, Dr. Rowe shares how he helps patients with new technologies and advanced treatment options to relieve chronic pain of the spine, including the low back and neck.
You practice a unique subspecialty. Could you tell us more about it?
When you have chronic pain, there are two ends of the spectrum where you can seek treatment.
At one end of the spectrum are physiatrists who utilize non-surgical and minimally invasive approaches and procedures to treat your pain. These approaches might range from exercise to physical therapy, medication management, and injections such as epidural steroid injections, facet blocks, and SI joint injections. Anesthesiologists who have had a spine fellowship also traditionally use these approaches.
At the other end of the spectrum are orthopedic and neurologic surgeons. They focus on much more major surgical procedures to address spine pain issues. These procedures include lumbar and cervical fusions and decompressive laminectomies to relieve pressure on the spinal nerve roots.
Many new treatments fall in the gap between these two extremes. These are minimally invasive surgical procedures to relieve pain, appropriate when conservative treatment options haven’t provided long-term benefits. These procedures offer patients options that are far less severe surgically than those where orthopedists and neurosurgeons traditionally focus.
My surgical subspecialty is providing patients with pain relief options in this treatment gap.
What kind of treatments and procedures are we talking about in this gap?
Neuromodulation technologies have improved by leaps and bounds over the past five years, and they now incorporate improved batteries and Bluetooth technologies for programming.
Another minimally invasive treatment option is an interspinous spacer device, which can provide relief from lumbar spinal stenosis. This procedure can be an alternative to surgical decompression, such as a laminectomy.
I began to adopt these procedures four years ago when they officially became commercially available. Given that I was one of the early adopters of this treatment option, I now regularly teach other physicians and surgeons on the proper usage of this decompressive technology.
I also perform a minimally invasive SI joint fusion procedure. This procedure is often appropriate when SI joint injections fail to provide long term improvement.
In the past, SI joint fusion surgery involved a lateral approach with significant muscle disruption, requiring a lengthy recovery period. Now we use a posterior approach with a small incision to provide SI joint stabilization and fusion. This new alternative causes minimal tissue disruption and has a very short recovery period.
Beyond those, there are several other procedures that I’m currently using to provide additional minimally invasive treatment options, as well as others emerging on the horizon.
How did you end up with this specialty focus?
I have a surgical background from the start of my medical career. I completed two years of general surgery and then worked at a burn surgery center for eight years. These experiences provided me with an extensive foundation in handling complex surgical conditions.
I also completed a physical medicine and rehabilitation residency at the University of Pennsylvania Hospital and a spine fellowship. From that point, I began specializing in providing patients with access to technologies and treatments in the gap that weren’t previously available.
The sum of this training and experience enables me to consider, with a surgical perspective, how best to use these advanced procedures.
Dr. Jeffery Rowe teaching the spinal cord stimulation procedure.
What kind of patients do you see? When is it appropriate for a patient to consult with you?
I see a broad range of patients. Some have only recently experienced an onset of pain, and others have been suffering from pain for years.
I pride myself in offering patients treatments when they have been told they exhausted all available pain treatment options. These previous failed attempts may have included epidural steroid injections, facet blocks, SI joint injections, rhizotomies, and radiofrequency nerve ablations.
For example, let’s say a patient has multi-level degenerative disc disease and they’ve had multiple injections but still have ongoing symptoms. The injections may have worked well, but the effectiveness wore off over time.
This hypothetical patient is now at a point where they need a longer-term solution with a more permanent treatment option. Neurostimulation or an interspinous spacer device may be an appropriate option for them.
My initial consultation is extensive as I tease through the issues each patient has been dealing with. I need to hear their full backstory, including how long they have been managing their condition and what they’ve done previously to attempt to alleviate their pain. I also review their diagnostic studies, including any MRIs or CT scans.
This thorough evaluation allows the patient and me to review the treatment options which are best suited for their condition. It also enables me to recommend a long-term treatment plan using one or more of the new technologies that sit in the gap.
Nationally, neuromodulation therapies don’t always work effectively for some patients. Why is it that you seem to get successful results with your patients?
Our ongoing successes build from a variety of factors. Patient selection is key to having a successful outcome. I take great care where I place the leads and reinforce that with strict testing protocols to make sure I’ve optimized lead placement correctly. I also use an advanced lead anchoring technique, so the leads don’t move out of position.
I additionally attribute my success to performing hundreds of neuromodulation trials and implants each year for patients across the country and teaching these procedures nationally.
What is your life like outside of the Main Line Spine medical practice?
It is very important to me that I balance my medical practice with my family life. When you work as hard as I do, it’s crucial to have a great family support system.
My family includes my wife, two daughters, a Savannah cat, and a Belgian Malinois dog. We enjoy outdoor activities including hiking and riding dirt bikes. For me, at the end of the day, it doesn’t get better than that.
