Device Uses Nerve Stimulation to Ease Diabetic Peripheral Neuropathy Pain

About half of all those with diabetes suffer from diabetic peripheral neuropathy, a type of nerve damage that causes tingling, numbness and sometimes excruciating pain that can lead to serious problems.

According to Dr. Shai Gonzani, President and CEO of the Boston-based pain device company NeuroMetrix, five to six million people in the United States suffer some form of diabetic peripheral neuropathy, and for those whose condition is accompanied by pain, it can be absolutely debilitating.

“Peripheral neuropathy is the most common complication of diabetes,” said Dr. Gonzani in a recent radio interview. “One of the long-term problems is that it severely damages a person’s nerves, which causes many problems including the inability to feel the feet, severe pain or amputation,” especially common risk when foot injuries go unnoticed because of numb feet.

Sufferers can use treatments ranging from creams to prescription pain medications including opiates that carry the risk of addiction, but because pain is complex and personal, treatment can be complicated.

Also, two different types of nerves are impacted by neuropathy – “Some nerves carry sensation, the ability to feel, and some nerves carry pain sensation,” Gonzani said – and both are affected differently by the condition.

Because those treating diabetic peripheral neuropathy are working with two different types of nerves = when damaged one loses sensation, while the other triggers excruciating pain – treatment is never one size fits all.

For NeuroMetrix, a company founded as a spinoff from the Harvard-MIT Division of Health Sciences and Technology, and the challenge was to create a wearable medical device to help manage chronic pain. To do so, researchers took inspiration from existing pain-relief technology and targeted it specifically to diabetic neuropathy.

The SENSUS Pain Management system is a transcutaneous electrical nerve stimulator (TENS) – traditionally used to treat chronic neck and back pain – that is uniquely designed for people with diabetes and chronic pain.

The small device – similar in size to an ankle weight and lightweight enough to wear under clothing – provides pain relief by stimulating the nerves that carry non-painful sensations to the brain. The stimulation triggers the release of chemicals that decrease pain, essentially quieting the sensations. It is powered by a rechargeable lithium-ion battery and creates stimuli with a disposable, snap-in electrode that is changed every two weeks.

“If you stimulate nerves electrically, you can activate your own pain modulating systems in your own body in a drug-free way, and it can be very effective,” said Gonzani.

Because it can ease pain that otherwise may have kept users sedentary, it creates an opportunity for a more active lifestyle, which can also play a role in lowering blood sugar levels and preventing further nerve damage.

The SENSUS device is configured to manage the individual user’s pain levels, and the stimulations can be increased or decreased as needed.

Therapy sessions last about an hour and are activated by the touch of a button. It can be used as needed to manage pain, though waiting 30 minutes between sessions is recommended.

It is the first device of its kind that has received FDA approval to be used during sleep, making it especially attractive for those who find themselves unable to sleep due to the debilitating nerve pain.

It can be used in conjunction with other treatments including pain medications, and can be especially helpful when pain medications are not adequately addressing existing pain.

The SENSUS system is available at discounted rates for $329.99 for a single unit from medical supply companies, with a set of six electrode replacements priced at $60. It may be covered by some insurance plans and is available to Medicare patients through various durable medical equipment and mail order suppliers.

It can also be used to treat pain of fibromyalgia and shingles as well as conditions that disturb sleep such as restless leg syndrome.

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