1. Pain relief and health-related quality of life was significantly improved among those undergoing 10-kHz spinal cord stimulation, compared to conventional medical management.
2. Outcomes in pain relief were sustained through the six-month follow-up.
Evidence Rating Level: 1 (Excellent)
The global prevalence of diabetes is approximately 8.5% and it is estimated that roughly 20% of this group will develop painful diabetic neuropathy (PDN). This progressive pain condition is treated with a variety of pharmacological and non-pharmacological interventions, many of which are suboptimal in effectiveness or sustained adherence. This prospective, multicenter, open-label, randomized clinical trial compared conventional medical management (CMM) with 10-kHz spinal cord stimulation (SCS) plus CMM. Participants must have had PDN for at least one year refractory to gabapentinoids and at least one other analgesic class, lower limb pain ≥5 cm on a 10-cm visual analogue scale (VAS), body mass index of ≤45, hemoglobin A1c of ≤10%, daily morphine equivalents of ≤120 mg, and were deemed appropriate candidates for SCS. A total of 216 participants (M [SD] age = 60.8 [10.7] years, 37.0% female) were randomized with a six-month follow-up and optional crossover at six months. Within this sample, the durations of diabetes (median [IQR] = 10.9 [6.3 to 16.4] years) and peripheral neuropathy (5.6 [3.0 to 10.1] years) were calculated. The primary endpoint of 50% reduction in pain on VAS without worsening neurological deficits at 3 months was achieved by 5% of the CMM group and 79% of the 10-kH SCS+CMM group (95% CI 64.2 to 83.0, p<.001). A total of 60% of the latter group achieved remission of pain (<3 m or less for 6 months) compared to only 1% in the CMM only group (p<.001). Regarding neurological examination, 6% of the CMM only group and 72% of the 10-kHz SCS+CMM group improved from baseline to 3 months (95% CI 55.4 to 76.6, p<.001). A similar difference was found at six-month follow up (difference, 58.6%, 95% CI 47.6 to 69.6, p<.001). There was no significant change in hemoglobin A1c between groups at six-month follow-up. Overall, this study found that 10-kHz SCS offers substantial pain relief over six months in refractory PND, without significant declines in neurological examination.
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