10 kHz spinal cord stimulation for painful diabetic neuropathy

In the large, randomised-controlled SENZA-PDN trial, most subjects with painful diabetic neuropathy (PDN) benefitted from treatment with 10 kHz spinal cord stimulation. The results showed clear differences compared with the best available conventional medical treatments.

Most of the pharmacological treatments available for PDN, such as pregabalin and duloxetine, have a number needed to harm that is close to the number needed to treat. In the SENZA-PDN trial (NCT03228420), 216 PDN patients were randomised 1:1 to 10 kHz spinal cord stimulation plus conventional medical management or to conventional medical management alone. Subjects had a clinical diagnosis of PDN with symptoms ≥12 months; they were refractory to medications and had a lower limb pain intensity ≥5 on a 0–10 visual analogue scale (VAS). The combined primary endpoint was ≥50% pain relief and no worsening of baseline neurological deficits. Prof. Erika Petersen (University of Arkansas, USA) presented the results [1].

In the experimental group, average VAS scores decreased from 7.6 at baseline to 1.7 at 6 months. Only 2.3% of subjects had worsened symptoms, whereas 85% were deemed responders, defined as ≥50% pain relief. In the conventional management group, average VAS scores were 7.0 at baseline and 6.9 at 6 months; over half of subjects (52%) reported worsening pain. Just 6.3% of conventional management subjects were deemed responders (P<0.001). Neurological examination showed improvements for 65.9% and 8.5%, respectively, in the experimental and control group (P<0.001). Prof. Petersen noted that the primary endpoint as well as 7 of 8 prespecified secondary endpoints were met. Durability of treatment effects was demonstrated for 12 months; study follow-up will continue for another 12 months.

1. Petersen E, et al. Sustained Benefits for 10 kHz Spinal Cord Stimulation Treatment of Painful Diabetic Neuropathy - Six Month Results from a Multicenter Randomized Controlled Trial. AAN 2021 Virtual Congress, 17-22 April.

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Posted on 16 June, 2021