Improvement in Protective Sensation: Clinical Evidence From a Randomized Controlled Trial for Treatment of Painful Diabetic Neuropathy With 10 kHz Spinal Cord Stimulation
Authors' 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.
Study context
- Population
- Participants with painful diabetic neuropathy (PDN)randomized
- Participants
- 216 participants
- Comparison
- 10 kHz spinal cord stimulation (SCS) plus conventional medical management (CMM) vs CMM alone
- Primary endpoint
- Protective sensation in the feet (10-g monofilament sensory assessments at 10 locations per foot) and associated risk of foot ulceration
- Follow-up
- Baseline through 24 months
Methodological detailsoptional treatment crossover after 6 months
- Optional treatment crossover after 6 months
Primary result
As reported in the abstract
Number of sensate locations
- Increased sensate locations with 10 kHz SCS vs preimplantation
- P < .01
Further findings
Proportion of low-risk participants (10 kHz SCS) · preimplantation to 3 months, through 24 months
- Approximately doubled from preimplantation to 3 months postimplantation and remained stable through 24 months
- P ≤ 0.01
Original publication
Improvement in Protective Sensation: Clinical Evidence From a Randomized Controlled Trial for Treatment of Painful Diabetic Neuropathy With 10 kHz Spinal Cord Stimulation. J Diabetes Sci Technol. Published 9 January 2024. doi:10.
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