Breakthrough Treatment for Painful Diabetic Neuropathy With HFX™

HFX™ is a breakthrough for those struggling with chronic painful diabetic neuropathy, which is a condition that can occur in patients with diabetes. This newly and only FDA-approved treatment option provides innovative treatment for the pain associated with the condition. The treatment uses spinal cord stimulation, or SCS, to provide pain relief.

Until recently, there has been a lack of effective options for those dealing with chronic painful diabetic neuropathy. Spinal cord stimulation has been used for decades to treat chronic pain, but the treatment may cause paresthesia, which is a tingling or prickling sensation. HFX™ for painful diabetic neuropathy, or PDN, is a new safe and effective option that treats the pain associated with diabetic neuropathy. The system works by using a new 10 kHz high-frequency spinal cord stimulation therapy to deliver electrical energy around the spine, providing pain relief without discomfort.

If you’re struggling with chronic painful diabetic neuropathy you may be significantly impacted by the condition due to the pain, numbness, or burning sensation it can cause in the feet. HFX™ for PDN relieves pain so that patients can more fully enjoy their day-to-day lives without worrying about the limitations that the condition causes.

How effective is the procedure?

In this randomized clinical trial including 216 patients, there was a significant benefit of 10-kHz spinal cord stimulation, with 79% of treatment responders whose underlying neurological deficits did not worsen compared with 5% of controls treated with conventional medical management. The pain scores of patients who were treated with conventional medical management did not, on average, change significantly, the overall improvement of pain scores with HFX was nearly 80%.

Enjoy improvement in:

Enjoy significant pain relief

85% of people enjoy long-term pain relief

Sleep soundly

Reduce your pain and improve your sleep

(HFX for PDN. (2021). HFX for PDN.

Symptoms & Signs of PDN

PDN is a complication that can occur as a result of prolonged high blood sugar levels associated with diabetes. The condition is a type of nerve damage in patients with known diabetes that usually develops slowly and gradually. Symptoms start in the feet and can move to the legs in a stocking distribution. Early warning signs include numbness, pain, or a burning sensation in the hands and feet. Eventually, the symptoms can progress and become debilitating. You might experience severe pain that significantly disrupts your everyday life. If you’re experiencing peripheral neuropathy, HFX™ may be the right choice for you.

You will need to be diagnosed with PDN by your doctor before considering HFX™. Our providers at Anesis Spine & Pain Care can also make this diagnosis. If you are diabetic and experiencing pain or discomfort in your feet, it would be a good idea to visit a doctor.

A doctor will consider your medical history, lab tests, and clinical examination. They may check your muscle strength and reflexes, as well as muscle sensitivity to position, vibration, touch, and temperature. They may also request additional tests, such as electromyography or an ultrasound. Sometimes nerve conduction studies of the legs or skin biopsies for small nerve endings are performed to help diagnose the condition.

If you have been told your painful feet are due to diabetes, you could possibly benefit from treatment with HFX™.

Hear What Physicians Are Saying

How is the procedure done?

HFX™ for PDN involves a trial phase.
This allows you and your doctor to determine if the system is right for you before having the system implanted.

1. Trial phase

Before having HFX™ implanted, patients participate in a trial phase. During this phase, your doctor will place thin, flexible wires, called leads, are placed beneath the skin and next to the spine. This may be done under local anesthetic and you may be given medication to help you relax. This procedure is minor and usually doesn’t involve an incision. You can usually leave the hospital the same day, but it will depend on your condition and what your doctor thinks is best.

After the minor procedure is done, you will be able to familiarize yourself with the system and the remote control. You will be able to turn the stimulator on and off via the remote control, as well as increase or decrease stimulation. 

This phase will allow you and your doctor to see if the system is a good fit for you. If the system is deemed effective, the next phase is the permanent implant phase.

2. Implantation phase

The next step after the trial phase is the implantation phase, which is where the device is implanted in your body. This is done by a minimally invasive procedure and done under local or general anesthesia. Your doctor will select the implant location due to your specific body type and needs. They will then program the device, and you will be able to control it by the remote. The remote will be either the same one from the trial phase or a similar one.

3. Recovery process

After the procedure, the implanted device may be quite noticeable. Try to avoid touching or messing with it as if it flips over in your body, it will not work properly.

You may also experience pain and tenderness in the implant area, which is normal for SCS surgeries. Avoid touching the implant site. In the first several weeks after surgery, avoid sudden movements, bending over, lifting heavy things, and stretching.

It’s important to listen to your doctor’s instructions. They will tell you what you should and shouldn’t do. You will be given instructions on how to care for the wound.

What are the risks of the procedure?

The safety of HFX™ is similar to that of other SCS devices. Surgery does involve some level of risk. After implanting the system, risks include:

  • Pain at the surgical site
  • Anesthetic risks
  • Infection
  • Poor wound healing
  • Pain due to lead migration
  • In extremely rare cases, serious injury or death

Treating PDN with HFX™

At Anesis Spine & Pain Care, we have this unique technology available for patients dealing with chronic pain. If you are dealing with chronic painful diabetic neuropathy, contact us. Our providers can go over this procedure with you and determine if it’s the right treatment for you. Call and schedule a consultation with one of our providers to learn more about this procedure or other treatment options for pain relief.

Anesis Spine & Pain Care

Providing multi-disciplinary care for those suffering from chronic pain.

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*New Updates* Anesis is proud to announce the addition of a Bellevue location, the Bel-Red surgery center.
We are happy to announce a new location offering limited clinic and procedure availability. Ask if scheduling at this location is an option for you.