Boston PainCare

Painful Diabetic Neuropathy (PDN)

A prospective, randomized clinical trial to assess the efficacy of the Senza Spinal Cord Stimulator in the treatment of PDN.

  • Do You Suffer with Pain in Your Feet or Legs Due to Diabetes?
  • Have you been diagnosed with painful diabetic neuropathy or PDN by a doctor?
  • Are you 22 years of age or older?
  • Have you already tried at least 2 medications or other treatments for your PDN pain?
  • Was your last A1c less than 10?
  • Are you able to attend study visits in Waltham, MA?

If you have answered "Yes" to the questions above, you may qualify to participate in a research study for your pain!

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BACKGROUND ON CHRONIC PAIN AND SPINAL CORD STIMULATION

If you suffer from pain, you are not alone. Pain is the most common reason for physician visits in Europe and the United States. Living with severe pain can significantly interfere with your quality of life. There are many treatment options for chronic pain and your physician may recommend different treatments depending on the type of pain and severity of pain.

Spinal cord stimulation (SCS) is a proven therapy that offers a treatment option for chronic pain. SCS uses electrical pulses to interrupt pain signals, resulting in pain relief. Hundreds of thousands of people with chronic pain have received relief with spinal cord stimulation. This investigational study is evaluating the Senza SCS system to treat subjects with lower limb pain due to diabetes, also called diabetic neuropathy or PDN.

TREATMENTS IN THIS STUDY

If you qualify for and choose to participate in this study, you will be randomly assigned (50-50 chance, like flipping a coin) to one of two treatment groups:

  1. Conventional medical treatments: under the direction of your study physician, you may receive a variety of treatments, such as medications and physical therapy.
  2. SCS treatment: your study physician will perform a trial procedure to see if SCS works for you and may implant a permanent device if it is successful.

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