How is this working? Like a pair of noise-cancelling headphones, perhaps? Filtering out the painful sensation allowing for normal touch perception? Here are data from our combined teams. Perhaps this calls for a larger randomized controlled trial to confirm or refute these fascinating findings.
In a recent study titled “Improvement in Protective Sensation: Clinical Evidence From a Randomized Controlled Trial for Treatment of Painful Diabetic Neuropathy With 10 kHz Spinal Cord Stimulation,” we explored the long-term effects of high-frequency (10 kHz) paresthesia-independent spinal cord stimulation (SCS) on protective sensation in the feet and the associated risk of foot ulceration for individuals with painful diabetic neuropathy (PDN)[1].
PDN can result in the loss of protective sensation, leading to twice the likelihood of foot ulceration and three times the risk of lower extremity amputation. Our study aimed to evaluate whether 10 kHz SCS could help mitigate these risks[1].
The SENZA-PDN clinical study was a randomized, controlled trial in which 216 participants with PDN were randomized to receive either conventional medical management (CMM) alone or 10 kHz SCS plus CMM, with optional treatment crossover after 6 months. At study visits (baseline through 24 months), 10-g monofilament sensory assessments were conducted at 10 locations per foot[1].
The results showed that participants in the 10 kHz SCS group reported increased numbers of sensate locations as compared to CMM alone and to preimplantation. They were significantly more likely to be at low risk of foot ulceration using both classification methods. The proportion of low-risk participants approximately doubled from preimplantation to 3 months postimplantation and remained stable through 24 months[1].
In conclusion, significant improvements were observed in protective sensation from preimplantation to 24 months postimplantation for the 10 kHz SCS group. With this unique, disease-modifying improvement in sensory function, 10 kHz SCS provides the potential to reduce ulceration, amputation, and other severe sequelae of PDN[1].
This study is a significant step forward in our mission to end preventable amputation within the next generation. By exploring innovative interdisciplinary research and clinical practice, we continue to advance this goal.
Citations:
[1] https://journals.sagepub.com/doi/10.1177/19322968231222271
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