Spinal cord stimulation (SCS) has been around for about 40 years. This treatment has revolutionized treatment for many chronic pain patients. Historically, patients that had chronic pain or failed back surgeries were out of options. Many had to manage pain with only medications which offered many unwanted adverse side effects and limited long term effectiveness. See more about use of SCS therapy for chronic pain.
Differences Between Traditional & High Frequency Stimulation Therapy
There have been many advances in technology over the years including rechargable batteries, position sensors, and now MRI compatible devices. The newest breakthrough in SCS therapy is Nevro’s Senza® High Frequency device (HF10). Traditional low frequency SCS would deliver electrical impulses at a rate of 40-60 Hz. This would produce a paresthesia (tingling) sensation in the extremities. Often times this is a more pleasant sensation than the original neuropathic pain. The HF10 device can safely deliver electrical impulses up to 10,000 Hz. This means the patient can get relief of both back and leg pain without the paresthesia sensation. Some patients that also failed to respond to low frequency stimulation or were unable to tolerate the paresthesias have been able to find relief with the new higher frequency technology.
Procedure Overview For SCS Therapy
Implantation of both traditional and HF SCS devices are very similar, but also with one key difference. The lead wires are implanted through an injection through the skin. During the trial phase, the wires will be connected to the power source (IPG) outside your body and taped to the skin. The trial phase with HF10 devices should last about one week. During permanent implantation, the lead wires will be tunneled under the skin and the IPG implanted in the gluteal (buttock/waist) region.
During implantation with a traditional SCS, the patient would be sedated, then woken up mid procedure to asses location of the paresthesia. Adjustments would then be made as necessary. The location of the HF10 SCS gets implanted exactly the same for every patient, both during the trial phase and permanent implantation. And since there is no paresthesia, the patient does not have to be awake during any part of the procedure to asses effectiveness. Thus making it more comfortable for the patient, and a more efficient and reliable procedure for the doctor implanting the device.
Traditional Vs High Frequency Spinal Cord Stimulation Therapy – Stats
A head-to-head study was done comparing traditional low frequency SCS to high frequency (HF10) therapy. This study showed 44% back pain and 56% leg pain patients with traditional SCS reported at least 50% overall reduction in pain. Over 80% of back and leg pain patients with the HF10 therapy reported 50% or greater pain relief. Studies also showed sustained relief without adverse side effect at 24 months. These patients also were able to significantly reduce use of opioid medications and had overall improved sleep.
More Differences Between The SCS Stimulation Therapies
Some devices have recently been FDA approved for full body MRI after implantation. Nevro’s Senza® HF10 device is currently FDA approved for only head and extremity MRI and further investigations are being conducted. The HF10 battery life is also guaranteed for about 10 years with normal settings (same as traditional SCS devices), but needs to be charged on a daily basis. This brings up issues with patient compliance. Some traditional SCS devices can be programmed to the high frequency settings and offer similar results. However, the traditional batteries are not built to withstand long-term HF stimulation (yet). Since its paresthesia free, the HF10 therapy may be used while driving, while traditional SCS companies recommend against use during driving. The Nevro Senza® system received approvals in Europe in 2010 and Australia in 2011 and was only FDA approved in the US in 2015. The technology is still fairly new compared to traditional SCS, which have been around since the 1980s.
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Nevro.com. Accessed 11/19/15.Kapural L, Gliner B, Amirdelfan K., Yearwood T., & Yang T. (2015). Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain. Anesthesiology, 123(4).
Al-Kaisy A, Van Buyten J, Smet I, Palmisani S, Pang D, Smith T. (2014, eprint 2013). Sustained Effectiveness of 10 kHz High-Frequency Spinal Cord Stimulation for Patients with Chronic, Low Back Pain: 24-Month Results of a Prospective Multicenter Study. Pain Medicine 2014; 15: 347-354