The latest results from an ongoing study of an implantable spinal cord stimulation device — known as HFX — to treat pain from diabetic peripheral neuropathy show that it effectively relieves pain for at least 18 months, according to results announced at the 2022 meeting of the American Society of Clinical Endocrinology and described in an article at MedPage Today.
Previously, the same ongoing study showed that HFX was effective at relieving pain from peripheral neuropathy after six months and 12 months of treatment. HFX was approved by the U.S. Food and Drug Administration (FDA) as a treatment for pain from neuropathy in July 2021, based on the results of the study after 12 months. Those results showed that during both the first and second six-month period of use, HFX drastically outperformed conventional treatments for peripheral neuropathy in study participants — with 79% of participants who used HFX seeing at least a 50% reduction in their pain score during the first six months, compared with just 5% of participants who received conventional treatment. During the second six-month period, during which a larger group of participants used HFX, 86% saw at least a 50% reduction in their pain score.
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Spinal cord stimulation for neuropathy pain
HFX involves surgically implanting a device that stimulates the spinal cord by emitting high-frequency sound waves. It’s not the only device of its kind on the market — Medtronic also offers two devices that operate in a similar manner, both of which were approved earlier this year by the FDA as treatments for pain from diabetic peripheral neuropathy.
The latest study results show that during a third six-month period, HFX continued to provide effective pain relief to most people who used the treatment in combination with conventional neuropathy treatments. Similar to the results from the second six-month period, the latest results showed 85% of participants experiencing at least a 50% reduction in their pain score — a threshold that the researchers used to define “responders” to the treatment. But a significant number of participants were also “profound responders” — 54% of participants experienced at least an 80% reduction in their pain score. The average pain score reduction among HFX users was 73%.
Participants also reported improvement in symptoms of peripheral neuropathy other than pain, known as dysthesias — such as numbness, burning, or tingling in the affected areas, typically the legs and feet. And while it was not measured during the third six-month period, after 12 months, 63% of participants experienced improvement in motor, sensory, or reflex function in the effected areas. What’s more, 64% reported a reduction in pain interfering with their quality of life, and 70% reported an improvement in their sleep quality.
Throughout the trial, there were no significant changes in participants’ A1C levels (a measure of long-term blood glucose control) or body-mass index (a measure of body weight that takes height into account). Almost all participants, 95%, remained in the study for long-term follow-up, with only six participants out of 142 choosing to have the HFX device taken out. The average age of participants was 61, and almost all of them had type 2 diabetes, although a few had type 1 diabetes. Over the course of the study, eight participants experienced infections related to the implanted device, with three of these cases resolved with antibiotics and five cases requiring removal of the device.
Spinal cord stimulation therapy is generally reserved for more severe cases of peripheral neuropathy, since it involves surgical implantation and the associated risks of infection and other complications. But if your neuropathy isn’t responding well to conventional treatments and is significantly interfering with your quality of life, it may be worth discussing spinal cord stimulation as an option with your doctor.
Want to learn more about neuropathy? Read “Coping With Painful Neuropathy,” “Diabetic Neuropathy,” and “Controlling Neuropathic Pain.”
