Discover the groundbreaking strides in alleviating diabetic nerve pain as we delve into the latest clinical evidence on the efficacy of 10 kHz spinal cord stimulation.
– by James
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Improvement in Protective Sensation: Clinical Evidence From a Randomized Controlled Trial for Treatment of Painful Diabetic Neuropathy With 10 kHz Spinal Cord Stimulation.
Argoff et al., J Diabetes Sci Technol 2024
DOI: 10.1177/19322968231222271
What’s New: The SENZA-PDN clinical study introduces the long-term benefits of 10 kHz spinal cord stimulation (SCS) in improving protective sensation in the feet of individuals with painful diabetic neuropathy (PDN), potentially reducing the risk of foot ulceration.
Importance: This study is significant as it suggests a disease-modifying effect of 10 kHz SCS, which could lead to a decrease in the high rates of foot ulceration and subsequent lower extremity amputations associated with PDN.
Contribution to Literature: The study provides evidence that 10 kHz SCS, in addition to conventional medical management (CMM), can significantly enhance protective sensation in the feet of PDN patients. The results showed that participants receiving 10 kHz SCS had a greater number of sensate locations on their feet (P < .001) and were more likely to be classified as low risk for foot ulceration using two different assessment methods. The proportion of participants at low risk for ulceration approximately doubled from before the implantation to three months after and remained stable for up to 24 months (P ≤ .01).
Numerical Details: The study involved 216 participants, with a significant increase in sensate locations and low-risk ulceration classification observed in the 10 kHz SCS group compared to the CMM group and their own preimplantation status.
The SENZA-PDN study is registered under ClinicalTrials.gov identifier NCT03228420.