Patients with diabetic neuropathy had both pain relief and neurological improvements 2-_ years after the start of spinal cord stimulation with 10-kHz. This is according to research published prior to its presentation at the annual meeting of the American Academy of Neurology.
The results are based on the longest available follow-up to spinal cord stimulation with a higher frequency than the 60-_nbsp originally approved by the FDA for diabetic neuropathy; Hz, according to the main author Erika A.Petersen, M.D., Professor of Neurosurgery at the University of Arkansas for Medical Sciences, Little Rock.
University of Arkansas
«One would expect someone who is 24 Suffering from diabetes and neuropathy for months, according to 2-_ years of age, there is a progression of neuropathy. We see that in terms of their nerve function, people are looking for 2-_ years have been stable or have shown improvements,» said Dr. Petersen in an interview. «So this is really revolutionary.»
Preliminary results are «promising,» said John D. Markman, M.D., Professor of Neurology and Neurosurgery, Vice Chair of Clinical Research, and Director of the Translational Pain Research Program at the University of Rochester (N.Y.) Medical Center, in an interview.Markman, who was not involved in this study, noted that while the results are encouraging, it is «less clear how much of [pain improvement] is due to what we would call targeted pain-relieving benefit from stimulation, or more due to other factors such as expectations.» The crossover rate and the degree of reduction in pain intensity are promising, he said, but «I think you have to weigh that enthusiasm against the fact that this is an open-label study.»
Although spinal cord stimulation has been around since the late 1960s, it was not until the 2000s that it was increasingly used to treat chronic nerve damage associated with neuropathic pain syndromes, explains Dr. Petersen. The FDA approved the new treatment indication diabetic neuropathy in 2015, and data from Abbott and Medtronic have shown that spinal cord stimulation was 60 years old. Hz has shown a benefit.However, some patients find the vibration or tingling sensation that the devices can cause at this frequency uncomfortable.
«They describe sensations such as crawling or ants running over the feet, or pinpricks and pain sensitivity,» says Dr. Petersen. «You create a vibration sensation in the same zone where they already feel these sensations of pulsating, pain, and vibrating, and sometimes it’s [with spinal cord stimulation at 60-_ Hz] even more unpleasant and even less satisfactory for them in terms of relief. Therefore, only a fraction of patients will actually use the treatment,» she said.
At 10 kHz, on the other hand, she said, «people don’t feel any vibration or tingling associated with it, it just blocks the pain signal.» The difference between the frequencies is comparable to that between «a lifeguard whistle and a dog whistle».
The new results included data from a 24-month follow-up from a randomized controlled trial investigating the effectiveness of radiofrequency spinal cord stimulation in painful diabetic neuropathy.The original 216-_ Participants enrolled in the study had at least 12-_ Symptoms of diabetic neuropathy for months and either could not tolerate medication or did not respond to it. The inclusion criteria also included lower extremity pain intensity of at least 5 on a visual analogy scale of 0–10 and a haemoglobin A1c value of no more than 10%.
In the first 6-_ Participants were randomly assigned to receive either 10 kHz spinal cord stimulation along with conventional drug treatment or to receive conventional drug treatment alone. The 6-month data of 187 Patients showed, as reported in April 2021 in the journal «JAMA Neurology» reported that 79% of patients who received spinal cord stimulation experienced at least 50% improvement in pain relief, with no worsening of their neurological deficits, compared with only 5% of patients who received conventional treatment alone.
Average pain scores increased by 2% in control participants, compared to a decrease of 76% in those on spinal cord stimulation devices.In addition, 62% of patients who received spinal cord stimulation showed a neurological improvement in reflexes, strength, movement, and sensation, compared to 3% of patients in the control group. The Results of the study prompted the FDA, to allow the device with 10 kHz
After 6 In the last few months, 93% of the control patients switched to spinal cord stimulation, while none of the patients using the devices chose to stop spinal cord stimulation. The 12-month data showed that 85% of patients who received spinal cord stimulation experienced pain relief of at least 50% of pain, with average pain relief of 74%.Patients also reported a statistically significant improvement in quality of life, as well as fewer pain-related impairments in sleep, mood, and daily activities.
Two Years after baseline, patients’ pain relief was still maintained, with an average improvement of 80%, and 66% of patients showed neurological improvement compared to baseline. No patient had to remove the device due to ineffectiveness. At 5-_ Patients had the device removed due to infection, while three other patients also developed infections, but these subsided.
«Being able to offer something that’s not a pharmaceutical without the side effects, something that shows an even longer duration of the response, is a really important outcome at this point,» said Dr. Petersen.
Among the estimated 37 Millions of Americans with type 1 or type 2 diabetes, about a quarter suffer from painful diabetic neuropathy.However, medication and other medical treatment strategies are not always sufficient in managing their pain. After a 1-week trial period of spinal cord stimulation, the device is implanted under the skin and can last up to 10 weeks. Can be recharged through the skin for years and then replaced.
A suitable candidate for spinal cord stimulation would be someone for whom noninvasive pain relief options, including medications, are ineffective or intolerated, Petersen and Markman said. An appropriate study on medications does not involve a «one-size-fits-all» approach, but would vary from patient to patient, added Markman, who was also interested in whether participants in this study were able to achieve a reduction in painkillers.
«I think there are a significant number of patients who can benefit from this. That’s why this is so promising and exciting,» he said. Markman.»I think it’s important to see if it actually makes them take less medication or if the stimulation turns out to be another treatment on top of their basic treatment.» The challenge is to identify «which patients are most likely to benefit and which are most likely to be harmed.» Apart from an infection caused by the implantation, other possible risks include pain at the position of the battery and, in rare cases, the need for a new operation due to a change in the position of the electrodes.
After the wound caused by implantation has completely healed, patients using the device have no further activity limitations, other than the absence of magnetic interference such as that caused by MRIs, Petersen explained. «I’ve had people go kayaking in the wilderness afterwards, dive, fish with their grandchildren, do all kinds of activities.If patients need a scan of any kind, they should ask if it is safe for a pacemaker, as these devices are something of a «pacemaker for pain.»
«I had a patient who took solar chargers so he could recharge his battery while kayaking in remote woods, because that was the level of pain relief he was experiencing—from barely being able to walk down the hallway to being comfortable and being able to be active again even without a grid connection,» said Dr. Petersen. «Such improvements in quality of life are massive.»
The study results may also suggest that spinal cord stimulation may benefit a broader population of patients with neuropathic pain, Markman said. «There is an extraordinarily large need for neuropathy therapies, and an important question here is to what extent the diabetic neuropathy and response that we are seeing here are representative of a broader effect in many neuropathies caused by conditions other than diabetes,» Markman said.»There are many reasons to believe that this will be helpful not only for diabetes-related neuropathic pain, but also for other types of neuropathic pain that are associated with a similar clinical picture or clinical symptoms as diabetic peripheral neuropathy.»
The study was funded by Nevro, the manufacturer of the devices.
This article was originally published on mdedge.com.
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