A neurostimulation device that harnesses motion sensor technology found in smart phones and computer gaming systems has been approved for the treatment of chronic back and/or leg pain by the US Food and Drug Administration.
The device, AdaptiveStim With RestoreSensor (Medtronic), uses an implantable pacemaker-like device to interrupt pain signals, transforming them into a tingling sensation instead of pain. In a news release from Medtronic, the manufacturer points out that the device automatically tailors the level of stimulation to the needs of people with chronic back and/or leg pain by adjusting stimulation to accommodate changes in body position.
The device records the level of stimulation required for different positions, so that the intensity of stimulation remains consistent with a person's movements. In contrast, current nonadaptive technology requires that patients manually adjust neurostimulation settings with a handheld programmer.
In a clinical trial, 86.5% (64/74) of patients included in an intent-to-treat analysis reported more pain relief with no loss of convenience, or improving convenience with no loss of pain relief, through use of the device compared with during a control period in which the participants manually adjusted neurostimulation settings using a patient programmer.
In addition, more than 90% of participants indicated that they would keep the device turned on all or most of the time, and 80.3% reported functional improvements, including improved comfort during position changes. Use of the device was not associated with an increase in adverse events.
"This research provides important clinical evidence that demonstrates this innovative, position-sensing technology improves pain management and makes it easier for patients suffering from chronic pain to better manage their symptoms when compared to systems that require manual changes in stimulation," noted David Schultz, MD, founder and medical director of MAPS Pain Clinics and MAPS Applied Research Center in Minneapolis, Minnesota, and an investigator in the RestoreSensor clinical trial, in a the release.
Emma Hitt, PhD • Medscape Medical News © 2011 WebMD, LLC