High-Frequency Spinal Cord Stimulation Included in Endocrinology Guideline for Painful Diabetic Neuropathy Treatment
High-frequency (10 kHz) spinal cord stimulation (HF-SCS) is now included in the Diabetes Clinical Practice Guideline for painful diabetic neuropathy (PDN) treatment by The Association of Clinical Endocrinology (AACE). Inclusion of HF-SCS was based on the results from the SENZA-PDN trial (NCT03228420).
"For a clinician specializing in providing care for patients with diabetes, helping those with intractable pain of peripheral diabetic neuropathy is probably the most frustrating aspect of my practice," commented Dr. George Grunberger, chairman of the Grunberger Diabetes Institute in Bloomfield Hills, Michigan and past president of the American Association of Clinical Endocrinologists. "There is a dearth of effective medications approved by the FDA for its management, and none of these are disease modifying. Medications that are being used are in many cases ineffective and/or associated with side effects. Of course, their use also necessitates life-long adherence. It was thus welcome news when the FDA approved HF-SCS for the management of PDN and also encouraging to see that its use for these patients is listed in the latest update of the AACE guideline for comprehensive care planning for diabetes."
Participants in the SENZA-PDN trial who received SCS had significantly more pain relief and experienced better sleep, mood, and ability to carry out daily activities due to lower pain interference. At 6 months, 74 of 87 participants who had SCS had at least a 50% reduction in pain and making the number-needed-to-treat (NNT) with SCS 1.3 (95% CI, 1.1-1.4) for 50% pain release.After 12 months of treatment, participants had health-related quality of life (HRQoL) improvements of 2.5- to 4.5-fold higher than the minimal clinically important difference.
"This is a very positive endorsement of our proprietary, high-frequency 10 kHz therapy by an important community of health care providers specializing in endocrinology, diabetes, and metabolic disorders," stated D. Keith Grossman, chairman, chief executive officer and president of Nevro. "Based on our strong and growing body of published, peer-reviewed clinical trial data that demonstrated twice the patient responder rate, twice the pain relief and the only study to demonstrate neurologic improvements, we believe that our HFX solution is uniquely positioned to provide relief to the thousands of patients suffering from PDN."