Medtronic, a medical device manufacturer, recently received FDA approval for AdaptiveStim with RestoreSensor, a neurostimulation treatment for patients suffering from chronic leg or back pain.

"I think at some point the FDA label will be expanded to include other pain areas besides the trunk and limbs," says Dr. David Schultz, founder and medical director of MAPS Pain Clinics and MAPS Applied Research Center in Minneapolis, and the lead RestoreSensor clinical trial investigator. But as for now, he says, Medtronic can only market the product for those two areas of the body.

Neurostimulation involves the implantation of a small spinal cord stimulator underneath the skin, which basically transforms chronic pain into a tingling sensation by altering pain signals before they reach the brain.

Using motion sensor technology similar to the kind used in smart phones, AdaptiveStim with RestoreSensor adjusts its stimulation levels based on the movement of the patient. Other neurostimulation treatments require patients to make manual adjustments when they change positions.

"This device allows the doctor who puts it in to program it to change the power that it's delivering based on the body position," explains Dr. Schultz. "It takes neurostimulation to a more advanced and sophisticated level."

According to the U.S. RestoreSensor clinical trial, 80.3 percent of participants said they experienced improvements such as an increase in comfort during position changes while using the product.

Some of the potential risks--no different than those of other neurostimulation treatments--include pain at the implantation site, bleeding into the outer portion of the spinal canal and infection. On rare occasions, some patients who are initially able to tolerate the stimulation become bothered by it over a period of time.

Eva Adamson, an advocate of the product, had been suffering from debilitating chronic pain that radiated from her lower back all the way down to her foot. After undergoing physical therapy, steroid injections and pain medications, which negatively affected her level of concentration and quality of life, she was surgically implanted with the AdaptiveStim with RestoreSensor in 2010 as part of a study.

Ever since then, Adamson has been using the device 24 hours a day, seven days a week. She checks the rechargeable battery on a weekly basis and charges it at night while she sleeps. "This has been the best thing that I have ever encountered in my life, it has completely taken my pain away," she says, explaining that she has not needed to use narcotics for over a year.

Now that AdaptiveStim with RestoreSensor has been approved by the FDA, Adamson hopes the word will spread about the product, which she is confident will be able to help others as it did her.

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