Spinal cord stimulation advances therapy for painful diabetic peripheral neuropathy
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Diabetic peripheral neuropathy is a debilitating, progressive neurologic disorder that affects about 30% of adults with diabetes. Spinal cord stimulation is a newer option for addressing moderate to severe pain related to the condition.
High serum glucose levels damage nerves, leading to numbness and burning or stabbing pain. Diabetic peripheral neuropathy can occur throughout the body, but it most often affects the legs and feet. The condition has a significant and negative impact on patients’ quality of life and functional ability, including mood, social relationships and sleep.
For some patients, the pain can become progressively worse and excruciating. In a recent poll of people living with diabetes, 65% of respondents said pain affects their daily life, 72% said pain has had a major or moderate impact on their daily life, and 65% said they have been referred to a pain specialist.
The patients I see with diabetic peripheral neuropathy, who typically have advanced disease and have been living with it for years, struggle not only with pain, but also with challenges in balance that limit mobility. This lack of balance occurs when pain in the foot interferes with sensation signaling that the brain uses to determine the patient’s position in space or proprioception. Pain and reduced ambulation can significantly reduce quality of life for these patients.
Concerns with available medications
There is no cure for diabetic peripheral neuropathy, and treatment is directed at slowing progression, relieving pain and managing complications. Mild and moderate diabetic peripheral neuropathy may initially be treated with topical therapies, including capsaicin cream, which is available in prescription and over-the-counter formulations, and prescription lidocaine patches.
Moderate and severe diabetic peripheral neuropathy may be treated with a variety of oral medications. Two medications, pregabalin and duloxetine, are FDA approved for the treatment of diabetic peripheral neuropathy and are recommended as first-line therapy for the treatment of painful diabetic peripheral neuropathy. Gabapentin, an antiseizure medication, and amitriptyline, a tricyclic antidepressant, are often recommended by various guidelines as first-line therapy in this indication. Second-line therapy includes opioid-like medications, such as tramadol and tapentadol (Nucynta, Collegium), as well as additional antidepressants, such as venlafaxine and desvenlafaxine. Third-line recommendations from international and professional society guidelines have included opioids, which should be used with caution given their potential for addiction and abuse, and selective serotonin reuptake inhibitors.
It is important to note that none of these medications address the underlying biology of this painful condition. Additionally, these therapies often are only partially effective and can result in serious side effects. Consequently, there remains significant unmet need in treating moderate to severe pain related to diabetic peripheral neuropathy.
Effectiveness of spinal cord stimulation
Spinal cord stimulation is a newer option for addressing this unmet need. Spinal cord stimulation is a medical device-based approach that has been used for decades to treat chronic back and leg pain and has more recently been approved for the treatment of painful diabetic peripheral neuropathy, offering patients a new and potentially more effective treatment option.
The approach utilizes a small neurostimulator device that is implanted under the skin, similar to a pacemaker. Electrical impulses travel from the neurostimulator to the spine, interrupting pain signals between the spinal cord and the brain.
Data from several studies show that patients with diabetic peripheral neuropathy are 17 times more likely to experience significant pain relief if treated with spinal cord stimulation compared with conventional treatments alone. Overall, 86% of patients treated with spinal cord stimulation experienced treatment success after therapy for 1 year. Success in these studies included 50% reduction in pain or a significant improvement in Patient Global Impression of Change score; outcomes in a group of patients were tracked for 5 years.
Importantly, the majority of patients reported meaningful pain relief during 5 years of treatment with spinal cord stimulation, providing compelling evidence that this is an effective long-term therapy for managing chronic pain in patients with diabetic peripheral neuropathy.
It is also important to note that the higher the severity of neuropathy, the greater the likelihood of long-term treatment failure during the 5-year follow-up, affirming the urgency for earlier diagnosis and treatment and offering some insight regarding outcome expectations in the presence of more severe neuropathy.
Considerations when choosing a device
There are several spinal cord stimulation systems that are FDA approved for the treatment of painful diabetic peripheral neuropathy, including rechargeable and recharge-free platforms.
When considering spinal cord stimulation therapy with eligible patients, there are numerous factors that should be discussed. Some patients may prefer the longevity of a rechargeable device, whereas others may prefer the day-to-day convenience of a recharge-free device. For patients who prefer a recharge-free device, it is important to consider device longevity.
Another consideration is whether, and to what extent, the device is compatible with MRI. This may be especially important to discuss with patients who have additional comorbidities or health issues that may require MRI.
The importance and potential value of customized spinal cord stimulation treatment should also be discussed. Changes in patients’ body position can change the distance between the end of the lead and the patient’s spine, which can impact spinal cord stimulation efficacy. One study showed that 88.7% of patients treated with spinal cord stimulation for chronic neuropathic pain — not pain related to diabetic peripheral per se — reported better pain relief when using a technology that adapted neurostimulation based on seven different body positions.
Potential risks associated with spinal cord stimulation include infection, lead movement, pain at the implant site and loss of treatment effectiveness. Not everyone responds to therapy in the same way, and individual patients’ experiences may vary. Additionally, the risk for infection and severity of complications may be greater for patients with diabetes.
When selecting spinal cord stimulation device, providers and patients should consider the potential benefits of options designed with materials that potentially reduce the risk for infection and other potential surgical complications.
Finally, it is important to let patients know what to expect if they opt to undergo an implantation procedure. Typically, the procedure is performed in a hospital or surgery center on an outpatient basis and takes about 1 to 3 hours. Immediately after device implantation, patients will have several follow-up appointments during which the neurostimulation settings are adjusted. This includes whether or not patients feel a tingling or vibration sensation during stimulation, which some patients find pleasing and others prefer to avoid. Once the settings have been optimized, patients are typically seen for follow-up every 6 months.
With continued innovation of new technologies and therapeutic approaches, the treatment landscape for pain related to diabetic peripheral neuropathy is evolving and improving.
Patients now have choices about how to manage this pain, and it is important to help them understand the risks and benefits of each option in the context of their individual needs and priorities. Spinal cord stimulation has been shown to have an excellent risk-benefit profile in the treatment of pain related to diabetic peripheral neuropathy, and patients interested in pursuing the therapy have options with respect to features of different systems.
Clinicians who see patients with painful diabetic peripheral neuropathy, including endocrinologists, diabetologists, pain specialists and primary care providers, have an important role to play in helping these patients select a treatment option that best meets their health needs and daily living goals.
References:
- de Vos CC, et al. Pain. 2014;doi:10.1016/j.pain.2014.08.031.
- Schultz DM, et al. Pain Physician. 2012;15(1):1-12.
- Slangen R, et al. Diabetes Care. 2014;doi:10.2337/dc14-0684.
- Sloan G, et al. Curr Diabetes Rev. 2022; doi:10.2174/1573399817666210707112413.
- Snyder MJ, et al. Am Fam Physician. 2016;94(3):227-34.
- van Beek M, et al. Diabetes Care. 2018;doi:10.2337/dc17-0983.
For more information:
Eric Grigsby, MD, is a board-certified pain physician in Napa, California. He can be reached at erich.sandoval@finnpartners.com.
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