In patients with painful diabetic neuropathy (PDN), high-frequency spinal cord stimulation (SCS) had a greater long-term pain response compared to pharmacotherapy. These results were published in Diabetes Care.
Patients (N=216) with PDN for ≥ 12 months with lower extremity pain ≥ 5 cm on a visual analogue scale, BMI ≤ 45 kg/m2 and glycated hemoglobin ≤ 10% were recruited for this study. Patients were randomized 1:1 to continue conventional care (n=103) or to receive high-frequency (10-kHz) SCS with usual care (n=113). In the SCS cohort, 90 participants received permanent implants. At 6 months, 81% of the group crossed over to the SCS cohort with usual care and 64 received a permanent implant.
Mean lower limb pain at baseline was 7.6 (95% CI, 7.2-7.9) cm in the SCS cohort and decreased to 1.7 (95% CI, 1.3-7.9) cm at 6 months. 2.1) cm back. The pain level was maintained for 12 months. This change in pain corresponded to a mean pain relief of 77.1% (95% CI, 71.8%-82.3%; p<0.001).
In the crossover cohort, pain was 7.2 (95% CI, 6.8-7.6) cm at baseline and remained unchanged through 6 months of usual care. After crossover, pain scores decreased by 70.3% (95% CI, 63.4% – 77.1%; p<0.001).
The response rate, defined as ≥50% pain reduction, was achieved by 86% of the SCS and 84% of the crossover cohorts.
Researchers observed neurological improvement, specifically sensory function, in 68% of the SCS and 62% of the crossover groups.
Procedure-related infections occurred in 5.2% and 3.2% required surgical explantation. The position of the implant was revised in 2 patients and 1 patient had to be revised due to lead migration.
The study authors found that high-dose SCS was effective for treating pain in patients with PDN. In addition to pain relief, SCS has not been associated with paresthesia and tends to decrease sleep disruption due to pain. This study was the largest randomized study of SCS and the results supported its use to treat PDN.
Disclosure: Several authors declared their affiliation with the industry. For a full list of disclosures, see the original article.
Petersen EA, Stauss TG, Scowcroft JA, et al. Durability of 10 kHz high-frequency spinal cord stimulation in patients with painful diabetic neuropathy unresponsive to conventional treatments: 12-month results of a randomized controlled trial. diabetes treatment. Published online November 29, 2021. doi:10.2337/dc21-1813
This article originally appeared on Clinical Pain Advisor