The US Food and Drug Administration (USFDA) has approved the spinal cord stimulation (SCS) system to aid in the management of chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome, low back pain, and leg pain.The new system is able to reduce pain without paraesthesia, or tingling sensation, by providing high-frequency stimulation at 10 kHz, with low-stimulation amplitudes.
Back pain is a common disability. Acute pain begins suddenly and is usually sharp in quality. Acute pain might be mild and last just a moment, or it might be severe and may last 3to 6months. In most cases, acute pain disappears when the underlying cause of pain has been treated or has healed. Unrelieved acute pain, however, might lead to chronic pain. Chronic pain is pain that lasts more than 12 weeks and may persist for years. Chronic pain might have originated with an initial trauma/injury or infection, or there might be an ongoing cause of pain. However, some people suffer chronic pain in the absence of any past injury or evidence of body damage.
The FDA's review of safety and effectiveness included data from a clinical study. During the study, 198 subjects with chronic intractable pain of the trunk and/or limbs were randomized to either the spinal cord stimulation system test group or a control group. The control group was made up of 97 subjects treated with another FDA-approved device that delivers stimulation in the 2 to 1,200 Hz frequency range.
In 75% of subjects treated with the spinal cord stimulation system, a 50% reduction in pain from baseline was achieved at three months, which was the primary target of the study, and an approximately 55% reduction at 12 months.
There were no stimulation-related neurological deficits, such as weakness in the limbs or tremors, observed for either treatment group. The most common adverse events associated with the spinal cord stimulation system included pain at the implant site and dislocation of the device lead under the skin.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm446354.htm.
Last Accessed on 13th May, 2015.
Posted on:
21 May, 2015
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