New Spinal Cord Stimulation Therapy Showing Promising Results

Does spinal cord stimulation (SCS) work in relieving pain?

Some data released at the American Academy of Pain Medicine Annual Meeting held in Maryland in March indicate that the technology is continuing to improve.

People who participated in an industry-first, randomized clinical trial comparing high frequency spinal cord stimulation (SCS) to conventional frequency SCS significantly improve their pain relief.

“The high-frequency SCS device demonstrated statistical superiority to traditional SCS by a wide margin for all primary and secondary endpoints,” said coauthor B. Todd Sitzman, MD, MPH.  He is a pain management specialist and anesthesiologist in Hattiesburg, Mississippi.

The high frequency stimulation device is manufactured by Nevro, and called the Senza HF10, which is not currently approved by the FDA. The system delivers pain-masking stimulation to the spinal cord at a rate of 10,000 Hz. (It should be noted that the study received financial support from Nevro Corp.)

This device was compared in a randomized clinical study to conventional stimulation device manufactured by Boston Scientific, called the Precision Plus, which is FDA approved and available in the U.S.  This device delivers pain-masking stimulation at stimulation rates between 50 Hz to 100 Hz.

The study included people with severe and chronic pain of the trunk or limbs (the indication for spinal cord stimulation therapy).  The participants were randomly assigned implantation with one or the other SCS device. Ninety people used the high frequency device, while 81 used the conventional stimulation device.

There was a significant reduction in back pain relief for both groups, however, those using the high frequency device consistently showed greater pain reduction. Similar findings were reported by those who entered the study due to leg pain, where both groups showed significant improvement, but those using the high frequency device had even greater pain reduction.

“These findings bode well for SCS therapy as a whole, showing it is effective in patients with back and leg pain, but HF10 was superior in back and leg pain at 3, 6, and 12 months,” Dr Sitzman said.

People ask what the risks of spinal cord stimulation are and does it really work?

Medtronic, another major player in the industry, describes it this way on their website.

The neurostimulation implant is placed under the skin surgically. So, surgical complications are possible, similar to other surgeries. These may include infection, pain at the site of surgery, and bleeding into the epidural space.

“Once the neurostimulation system is implanted, it’s possible that device complications may occur. These include jolting, lead breaking, and movement of the lead within the epidural space, which may require reprogramming, surgical replacement of the leads, or corrective surgery. These events may result in uncomfortable stimulation or loss of therapy”.

Have you had spinal cord stimulation?

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