Diabetic neuropathy is nerve damage caused by high blood sugar levels, and about half of all diabetes patients have some form of the condition. The most common symptom is simple numbness in the hands or feet, or both, but it can also turn into severe, even excruciating, pain. It has even led to amputation of the affected limb. The first line of treatment is usually the use of over-the-counter pain medications, such as acetaminophen, ibuprofen or a skin patch containing lidocaine, but physicians also use prescription medications like anti-seizure drugs, tricyclic antidepressants and norepinephrine reuptake inhibitors (SNRIs). This new report indicates a promising new way of dealing with the problem.
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The report, which was presented at the recent virtual scientific sessions of the American Diabetes Association, was based on a study known as SENZA-PDN. This study compared Conventional Medical Management (CMM) to HF10 therapy, which is a type of spinal cord stimulation, or SCS. HF10 therapy works by means of a small device implanted under the skin. Connected to thin wires positioned near the spine, the device emits pulses that reduce pain signals to the brain. According to Erika Petersen, MD, one of the trial researchers, “Spinal cord stimulation has been established for chronic back and leg pain, but being able to innovate in this population with diabetic neuropathy is really something that we anticipate will improve quality of life and functional benefit for a large number of patients who currently have been stuck with the options that are currently available.”
The study reported on results from 216 diabetes patients who were randomly assigned to one of two groups: one receiving CMM (103 patients) and one receiving HF10 SCS in addition to CMM (113 patients). The median age of the patients was around 61 and about two out of three were men. To qualify for the study, the patients had to have lower extremity pain of at least 5 out of 10 on the visual analog scale (VAS), which is a standard pain measuring tool patients use to rate their pain on a scale ranging from none to extreme.
After a three-month test period, the reported results were striking. Of the patients who had the SCS implantation, nearly eight out of ten (79%) reported a response of 50% or greater pain relief. Of those who received CMM only, a mere 5% of patients reported similar results. In the SCS group the VAS score went from 7.6 at the beginning of the study to 2.4 after one month and just 1.7 after three months. VAS scores in the CMM-only group went from 7.0 at the start to 6.7 at one month and then 6.5 at three months. The researchers also conducted sensory assessments of the targeted limbs after three months. They found a 72% improvement in the SCS group and just a 7% improvement in the CMM group. Finally, Petersen explained that while neuropathy pain often causes difficulty in falling asleep and awakening caused by pain, the researchers reported improvements in both areas in the SCS group after three months. She summed up the results by saying, “My overall takeaway here is that these initial three-month results are very promising.”
Despite the encouraging findings, a couple of obstacles stand in the way of the common use of SCS for neuropathy patients. First, according to Natalie H. Strand, MD, one of the researchers, “These patients are probably under-referred to interventional pain specialists. The primary care physicians and endocrinologists may not think of neuromodulation as an appropriate treatment and they may not know that it can be so effective.” The other issue has to do with insurance — not all insurance companies will cover SCS therapy for neuropathy because they consider the research data as yet insufficient. As Petersen explained, “I’ve had patients who clearly have every suggestion that they match the characteristics of our research population here, but the insurance will decline the procedure as being experimental.” She does, however, hope that this situation will change as more research is done: “My hope is that randomized, controlled trial results in a research study such as this is something that will improve the access of the therapy to patients who would not be able to afford it without having insurance cover the procedure.”