Among patients with painful diabetic neuropathy (PDN), high frequency spinal cord stimulation (SCS) had a higher long term pain response compared with pharmacotherapy. These findings were published in Diabetes Care.
Patients (N=216) with PDN for ≥12 months with lower limb pain of ≥5 cm on a visual analog scale, BMI ≤45 kg/m2, and glycated hemoglobin ≤10% were recruited for this study. Patients were randomized in a 1:1 ratio to continue conventional treatment (n=103) or receive high frequency (10-kHz) SCS with usual care (n=113). Among the SCS cohort, 90 participants received permanent implants. At 6 months, 81% of the usual care group crossed over to the SCS cohort and 64 received a permanent implant.
Mean baseline lower limb pain was 7.6 (95% CI, 7.2-7.9) cm among the SCS cohort, decreasing to 1.7 (95% CI, 1.3-2.1) cm at 6 months. The pain level was maintained through 12 months. This change in pain corresponded with a 77.1% (95% CI, 71.8%-82.3%; P <.001) mean pain relief.
Among the crossover cohort, pain at baseline was 7.2 (95% CI, 6.8-7.6) cm, remaining unchanged during the 6 months of usual care. After crossover, pain scores decreased by 70.3% (95% CI, 63.4%-77.1%; P <.001).
The response rate, defined as ≥50% reduction in pain, was achieved by 86% of the SCS and 84% of the crossover cohorts.
The investigators observed neurological improvement, particularly sensory function, among 68% of the SCS and 62% of the crossover groups.
Procedure related infections occurred among 5.2% and 3.2% required surgical explant. The location of the implant was revised among 2 patients and 1 required revision due to lead migration.
The study authors found that high-dose SCS was efficacious for the treatment of pain among patients with PDN. In addition to pain relief, SCS has not been associated with paresthesia and tends to decrease sleep disturbance due to pain. This study was the largest randomized trial of SCS and the results supported its use for the treatment of PDN.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Petersen EA, Stauss TG, Scowcroft JA, et al. Durability of high-frequency 10-khz spinal cord stimulation for patients with painful diabetic neuropathy refractory to conventional treatments: 12-month results from a randomized controlled trial. Diabetes Care. Published online November 29, 2021. doi:10.2337/dc21-1813