Superior Back and Leg Pain Relief with High Frequency Spinal Cord Stimulation

Superior Back and Leg Pain Relief with High Frequency Spinal Cord Stimulation

Results of a clinical trial comparing high frequency spinal cord stimulation and low frequency spinal cord stimulation show that people with intractable back or leg pain benefit most from high frequency stimulation.  The SENZA-RCT multi-center study was published in the September issue of Neurosurgery.

High frequency stimulation (10 – kHz) delivers pulses of electrical stimulation to the spinal cord at a rate of 10 kHz, which is significantly higher than the 50 Hz rate traditional low frequency stimulation devices deliver.

The study enrolled 241 patients across 11 U.S. clinical trial sites (171 patients received SCS implants at 10 sites), making it the largest prospective randomized spinal cord stimulation (SCS) study to assess the treatment of chronic back and leg pain.  The measure of effectiveness was having participants achieve greater than or equal to 50% reduction in back pain compared to their baseline after 3 months, compared to those treated with traditional SCS therapy.

For those in the study with back pain, more than 84% using high frequency SCS therapy achieved the endpoint, while only 43% of people using low frequency SCS therapy did (P <.001 for non-inferiority and superiority).

For those in the study with leg pain, after three months, 83% of those using high frequency SCS therapy had a reduction of pain that was greater than or equal to 50% better than baseline.  For low frequency SCS therapy, only 55% met the endpoint (P <.001 for non-inferiority and superiority).

After 24 months of using the two therapies, the differences held true for both back pain and leg pain.  More than 66% of people with back pain using high frequency SCS therapy continued to experience more than 50% reduction compared to baseline.  Slightly more than 41% of those using low frequency SCS therapy experienced similar outcomes.  For those with leg pain, the figures were 65% for high frequency SCS therapy, and 46% for low frequency SCS therapy.

“Chronic pain is a significant public health problem that impacts an estimated 100 million American adults.  More Americans are impacted by chronic pain than diabetes, heart disease and cancer combined and innovative, non-opioid treatments that work over a longer period of time are needed,” said Leo Kapural, M.D., Ph.D, the Principal Investigator of the study.

“By demonstrating a significant and durable decrease in back and leg pain over a two-year period, Nevro’s HF10 therapy represents an important and evidence-based advance in pain medicine.  As we read in the paper every day and hear mounting concern from regulatory agencies, treating chronic pain conditions with opioids is fraught with risks.  HF10 therapy is a non-opioid, reversible therapy that may represent a compelling option for many of these suffering patients.”

SENZA-system-with-IPG1500-1-300x200

Senza Spinal Cord Stimulation System

The Senza HF10 spinal cord stimulation system provides high frequency electrical pulses to the spinal cord to alleviate pain.  The electrical pulses are delivered by small electrodes on leads that are placed near the spinal cord and are connected to a compact, battery-powered generator implanted under the skin.  HF10 therapy is the only SCS therapy indicated to provide pain relief without paresthesia (a stimulation-induced sensation, such as tingling or buzzing, which is the basis of traditional SCS).

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Authored by: Staff

There are 9 comments for this article
  1. John at 11:33 pm

    Where would you get this procedure in Australia

  2. Maryellen Faysal at 9:35 pm

    I actually have a Metronic Pain Pump and have had it for almost 20 yrs now. It needs to be replaced about every 5 yrs because of the battery, but it’s a godsend for me. Before the pump, which has dilaudid in mine because the morphine didn’t do much, I pretty much couldn’t move because of crippling back, hip and leg pain. Now with the pump and oral meds, my pain is reduced from a 10 to about a 6, and I could have the pump set higher, but do not want to be loopy. I workout every day on an elliptical and that helps with the pain as well. I’ll never be pain free, but it’s a lot better than it was without the pump!!

  3. Tim Mason at 8:39 pm

    Kathy, you need to go to http://www.FDA.gov and search medical device recalls. Search by manufacturer and look at the top three or for reasons for explanation of these devices. None of this is in the device literature the doctor gives you. These are a method of last resort and in some cases and with some physicians an “exit strategy” for some patients. Infection is the number 1 problem, number 2 unit does not work like the trial and number 3, over or under stimulation and migration of leads. Many tire of it and let the battery run down. It is freedom of information and anyone can find it.

  4. Tanja at 5:58 pm

    SCS leads can move in addition to cause scar tissue to form around them. I know of cases where the leads couldn’t be removed because of that. Your duration can also be accidentally ripped or punctured while placing the SCS. These risks are often down played .

  5. Kathy C at 4:16 pm

    Please! They have been advertising these things for 2 Decades. Even after they were pulled off of the Market. A lot of people had bad experiences, and we have no idea how “Scientific” this was. The number of Subjects is suspicious. There is a lot of money to be made here, and we only got the results of one more limited Industry “Study.”

  6. Daniel at 11:38 am

    I don’t trust any of these gadgets or any gadget doctor. Look up Medtronic pain pump this is what they now want to implant and fill with time released morphine or medications. Please Google it and BEWARE…. stay away from these gadgets they do more harm than good

  7. Kim Fox at 8:35 am

    I agree that the spinal cord stimulator is great for chronic pain. I’ve had mine, a product of Boston Scientific, for 6 weeks now and it is amazing!

  8. Candice Hawkins at 8:09 am

    My son has had horrific foot pain due to reconstructive surgery as a child. The Nevro system has given him 50% pain relief but on bad days he still needs his meds but only half as many. I believe these adjunct therapies are going to be the future for pain patients but I still do not think opioids should be removed from pharmaceutical therapy for these patients.
    Just seeing the message given to the nurses who work with me from the Surgeon General makes me laugh. I don’t know of one doctor I’ve worked with in the last 35 years who did not know opioids were addictive. This new SG is a strange bird.

  9. Tim Mason at 4:21 am

    These may well indeed work for leg pain but the literature and NIH data states that these devices are ineffective for low back pain.
    I recently had an MRI on my lower lumbar 9/2016. Before the MRI I was asked if I had one of these devices. I said no. I asked the operator of the 3-Tesla and 2-Tesla instrument what would be the problem if I had gotten one of these a month or two ago. She said ” You would not be getting an MRI”
    Here is something that men should be aware of if they are considering a SCS. The current diagnostic technique to locate and diagnose prostrate cancer is done using MRI. MRI is less invasive than the biopsy done thru the rectum. This biopsy procedure can even spread prostrate cancer. Insurance now covers MRI for prostrate cancer diagnosis. There is a physician here in Chattanooga that has developed the MRI procedure for locating cancers that urologists could not find even after several biopsies.
    Bottom line, if you have a SCS and would benefit from MRI diagnosis you may not be able to get one.
    BPH is common in male and a high PSA or increasing PSA will trigger your urologist to schedule a biopsy.
    I just wanted to drop this here on a fresh article about SCS.