Do your patients experience pins and needles in their arms or legs at night? Or burning, stabbing, and shooting pains? Perhaps their balance or coordination is deteriorating? All these symptoms could be signs of peripheral neuropathy.
Peripheral neuropathy is damage to the nerve’s hands and feet. It is one of the most common diabetes related complications, with around 60 to 70 per cent of people with diabetes having some level of neuropathy. Painful Diabetic Neuropathy (PDN) affects around 20% of patients living with Diabetes and often causes severe burning pain or numbness in the feet1.
Due to the loss of feeling cuts and injuries that go undetected can develop into significant health issues, which is why neuropathy is taken so seriously.
Historically this condition has been difficult to treat, with medications commonly abandoned by patients due to sub-optimal effect or unacceptable side effects 2,3.
In April 2021, the Landmark SENZA-PDN Clinical Trial Results were published in JAMA Neurology. The Level I Randomized Clinical Trial demonstrates significantly improved and sustained outcomes with 10 kHz Spinal Cord Stimulation. Patients Suffering from Painful Diabetic Neuropathy experienced substantial, sustained pain relief and improved health-related quality of life. Durability of 10 kHz Spinal Cord Stimulation was shown at 6 months result include:
85% of participants in the 10 kHz SCS study arm reported pain relief >50% versus 5% in the CMM control arm (p < 0.001).
average pain relief in the 10 kHz SCS treatment arm was 76% (% reduction of VAS from baseline) as compared to an average worsening of 2% in the control arm.
62% of the 10 kHz SCS treatment group had observed improvement upon an investigator-assessed neurological examination, compared to 3% in of CMM subjects (p < 0.001).
92% of patients were either “satisfied” or “very satisfied” with 10 kHz SCS therapy compared to 91% of CMM patients who were either “dissatisfied” or “very dissatisfied” with treatment.
Sleep disturbance due to pain in the 10 kHz SCS group was remarkably diminished.
Safety was consistent with published reports of adverse event rates in traditional SCS trials, including for infections and explants in non-diabetic cohorts.4,5,6