About the SENZA-PDN trial

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Diabetic Nerve Pain Clinical Trial

The main goal of the trial is to compare HF10® when combined with standard medical treatment1 to standard medical treatment alone to see if this combination is more effective at reducing patient-reported pain levels.

While HF10® has been approved by the FDA for the relief of chronic trunk and limb pain—and shown to be highly effective for the long-term back and leg pain relief2—it is not being investigated for the treatment of painful diabetic neuropathy.

Participants will be conveniently assigned to one of 15+ study locations and randomly selected into one of two groups—HF10® plus standard medical treatment or standard medical treatment alone. Regardless of the group assigned, participants will be on diabetes management for the 2 years they are in this study. Study-related medical treatment and care will be provided at no costs to participants.

1 Standard medical treatment includes the use of medication, physical therapy, cognitive therapy, chiropractic care, nerve blocks and other noninvasive or minimally invasive therapies.
2 Kapural L. et al. 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) Traditional

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Goals of the trial

Assessing the long-term
pain-reducing effects of HF10®

Assessing the impact of pain relief on one’s quality of life

Reducing the use of pain medications

If you’ve been diagnosed with diabetic neuropathy and have significant pain in your feet and/or lower legs, you may be eligible to participate in this trial.

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What is HF10®?

A unique type of spinal cord stimulation

Spinal cord stimulation (SCS) is a well-established approach to pain relief that’s been used in clinical practices throughout the United States for more than 30 years.

How it works

A device that looks similar to a pacemaker is implanted under your skin, just above the beltline or in the buttocks. Implanting the device is a minimally invasive procedure that can be performed on an outpatient basis, so you can go home the same day.

Once implanted, the device delivers mild electrical pulses that quiet the nerves that send pain signals to the brain, thus reducing pain.

There are 4 key components in the HF10® system:

Here are a few facts about pain relief with HF10®

It’s been shown to significantly relieve pain in patients suffering from chronic pain of the back and legs.2

It can be left on at all times because it calms the nerves but allows you to feel everything you should.

It differs from pain medication in many ways.
There is no risk of addiction, and it doesn’t cloud your thoughts or cause drowsiness or constipation.

2 Kapural L, et al. Comparison of 10-kHz high-frequency and traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain: 24-month results from a multicenter, randomized, controlled pivotal trial. Neurosurgery. 2016;79(5):667-677.

Curious to learn more about this clinical trial?

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About Nevro

Nevro is a medical device company and creator of HF10®, an innovative, evidence-based treatment for chronic pain.

Our goal is simple:

to help more patients suffering from chronic pain achieve lasting relief.