An Answer For Painful Diabetic Neuropathy?

Noninvasive, magnetic-based Axon Therapy offers promise in trials for difficult-to-treat condition.

Dr. Cordner uses Axon Therapy to treat a patient with painful diabetic neuropathy.

It is estimated that half of all people with diabetes develop peripheral neuropathy, a condition in which damage to small nerve endings results in numbness, burning and pain in the hands, feet, arms and legs.

Also known as painful diabetic neuropathy, it is caused by excess glucose in the blood and most often affects the feet and toes. Despite its commonality, however, the condition has long confounded physicians.

“Historically, painful diabetic neuropathy has been very difficult to treat,” confirms Harold J. Cordner, MD, FIPP, ABIPP, a board-certified pain management specialist at Florida Pain Management Associates. “Some physicians prescribe medications; others try spinal cord stimulation or nerve treatments. But often, those therapies are not very successful.”

A few years ago, a company called Neuralace Medical began studying a new way to treat patients at a Veterans Affairs medical center. These patients suffered from postsurgical and post-traumatic pain from amputations or nerve injuries.

“The researchers used magnetic peripheral nerve stimulation therapy (mPNS), where very strong pulses of magnetic energy are applied to the affected nerves’ axons, which are long projections that come out of the nerve bodies and go to the tissues,” Dr. Cordner describes.

“Also called Axon Therapy®, this treatment delivers a strong magnetic field to the nerves that stimulate pain going to the brain. In turn, the magnetic energy suppresses pain signals coming from the brain down the spinal cord and out to the tissues.”

Level One Study

Neuralace’s VA study was eventually deemed a success. As a result, Neuralace is researching whether Axon Therapy can ease the discomfort caused by painful diabetic neuropathy.

As part of that study, Florida Pain Management Associates is participating in a randomized, placebo-controlled, double-blinded clinical trial of Axon Therapy for painful diabetic neuropathy using the Axon Therapy device.

“Neuralace currently has FDA clearance for the treatment of chronic post-traumatic and postsurgical pain,” Dr. Cordner reports. “The goal of this study is to obtain FDA approval for Axon Therapy for the treatment of painful diabetic neuropathy.

“This is a Level One study where some patients are randomized to the Axon Therapy, some are randomized to placebo, and none of the patients know whether they’re getting the therapy or the placebo.

“This type of study provides the strongest evidence. Our study is set up to produce the most rigorous and valid scientific data that is looked for by the FDA and insurance companies.

“We recently received approval from the FDA and IRB (Institutional Review Board) to begin the study, so we are now enrolling patients. The treatment is free to participants, who will be reimbursed for their time as long as they complete the six months of follow-up that’s part of the study.”

The research comes on the heels of a small pilot study that evaluated Axon Therapy in the treatment of painful diabetic neuropathy and was deemed “very successful,” according to Dr. Cordner.

“The patients in that study reported approximately 67 percent pain reduction,” the doctor notes. “Further, 70 percent received greater than 50 percent pain relief.”

A New Twist

The use of magnetic therapy in the treatment of medical conditions is not new. For years, magnetic therapy has been used in the treatment of depression. Known clinically as transcranial magnetic therapy, that approach supplies magnetic energy to the brain.

The use of magnetic therapy in painful diabetic neuropathy will work in a similar manner by delivering magnetic energy to the peripheral nerves.

“Everyone has a central nervous system that includes the brain and spinal cord, which is traditionally where pain is transmitted,” Dr. Cordner educates. “The peripheral nerves are the little nerves outside the brain and spinal cord.

“When we stimulate the peripheral nerves, pain signals travel to the spinal cord and ultimately to parts of the brain. Under functional MRI or PET imaging, we can see neural activity in the brain as we stimulate the peripheral nerves. We can also see increased activity in the descending inhibitory nerves functioning to suppress pain in the same functional MRI or PET scan.”

“There’s no surgery, no incisions and no needles. We simply place the magnetic device over the nerve, and it pulses.” – Dr. Cordner

If diabetic neuropathy leads to chronic pain for weeks or months, it begins to impact the brain and spinal cord. So, pain can become chronic due to dysfunction of the nerves in the brain and spinal cord.

“In theory, the magnetic pulsing resets and normalizes those nerves,” Dr. Cordner explains. “This stops the chronic pain and restores the nerves to healthy functioning.

Treatment Protocol

Axon Therapy uses a powerful magnet, similar to that used for an MRI, Dr. Cordner reports.

“The nice thing about this treatment is that it is noninvasive,” the doctor relates. “We apply the magnet, which looks like a large wand, over the affected nerves for 13 minutes. Patients sometimes feel a little pulsing, or their leg or foot may twitch, but it is not painful.

“There’s no surgery, no incisions and no needles. We simply place the magnetic device over the nerve, and it pulses strong magnetic energy. At the end of the treatment, patients simply go home. They do not feel any after-effects or unpleasantness at all.”

A typical protocol for Axon Therapy calls for three consecutive days of treatment during the first week. Over the following three weeks, patients receive one 13-minute session per week. Month two involves one treatment session every two weeks. After that, patients receive one treatment per month for three months.

“In some cases, a patient may need a treatment after the first three to six months if the pain starts to come back,” Dr. Cordner explains. “We’ve had very good long-term results without the side effects of medication, surgical incisions or needle sticks.”

The study will be conducted at Florida Pain Management Associates’ Sebastian and Vero Beach locations. For additional information or to enroll, contact the study coordinator at (772) 388-9998.

“It is very exciting to test a new therapy for painful diabetic neuropathy, a condition we’ve not had very good treatment for up to this point,” Dr. Cordner enthuses. “If this study is successful, people with painful diabetic neuropathy will achieve relief of their pain without invasive treatments or medications with side effects, but with a very high success rate.”

© FHCN article by Patti DiPanfilo. Photo courtesy of Florida Pain Management Associates. mkb
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