Faculty Bibliography

OBJECTIVE:The PDN-Sensory randomized controlled trial (RCT) evaluated the effects of high-frequency 10-kHz spinal cord stimulation (10-kHz SCS) on pain and sensory function in individuals with painful diabetic neuropathy (PDN). RESEARCH DESIGN AND METHODS/METHODS:Participants were randomized 1:1 to conventional medical management (CMM) alone or 10-kHz SCS plus CMM. The primary and key secondary end points were the proportions of participants with pain response (≥50% lower limb pain relief) and sensory improvement (≥3-point reduction in modified Toronto Clinical Neuropathy Score [mTCNS]). Hierarchical secondary outcomes included intraepidermal nerve fiber density (IENFD), sleep, and health and neuropathy-related quality of life (QoL). IENFD and mTCNS assessments were allocation blinded. RESULTS:A total of 91 participants were randomly assigned to CMM alone (n = 50) or 10-kHz SCS plus CMM (n = 41). In a modified intention-to-treat worst-case analysis, 27 of 34 participants in the 10-kHz SCS group who underwent a temporary trial achieved the primary outcome, versus 2 of 50 CMM-alone participants (P < 0.001). Among those with 6-month data, mTCNS sensory improvement was observed in 16 of 29 (55.2%) 10-kHz SCS participants versus 12 of 48 (25.0%) CMM-alone participants (P = 0.01). The mean change in lower-calf IENFD was 0.58 fibers/mm with 10-kHz SCS versus -0.07 with CMM alone (P = 0.03). Eight of 10 hierarchical secondary end points were met (including sleep and QoL). CONCLUSIONS:The PDN-Sensory RCT replicated previous pain-reduction findings and showed prespecified, objective improvements in sensory function and IENFD. These 6-month findings support clinically meaningful benefit and are consistent with a potential disease-modifying effect that requires longer-term confirmation.

BACKGROUND:Given the low haemorrhagic risk of intracranial low-grade dural arteriovenous fistulas (dAVFs), the benefits of routine intervention remain controversial. This study compares patient outcomes treated with stereotactic radiosurgery (SRS) versus conservative management. METHOD/METHODS:Multicentre retrospective analysis of the Consortium for Dural Arteriovenous Fistula Outcomes Research and the International Radiosurgery Research Foundation data. Inclusion criteria were (1) intracranial low-grade dAVF diagnosed by catheter-based angiography, (2) no prior dAVF-related haemorrhage and (3) management with upfront SRS (intervention group) or conservative management (observation group). The primary outcome was symptomatic improvement. Secondary outcomes included dAVF obliteration, up-conversion, haemorrhage, improvement and favourable modified Rankin Scale (mRS) at follow-up. RESULTS:304 patients with a mean age of 56 years (SD 13.5) and a follow-up of 46.7 months (SD 45.5) were included. 135 (44.4%) were managed conservatively and 169 (55.6%) had upfront SRS. Compared with the observation group, symptomatic and mRS Score improvement (≥1-point decrease in baseline score) was more likely in the intervention group (95.1% vs 58.5%; OR=13.75 (5.61-33.69) and 37.0% vs 24.0%; OR=1.85 (1.09-3.15), respectively). These findings remained significant after multiple imputation and propensity score matching. Remaining outcomes were similar between groups. The all-cause mortality rate was 5.4% (n=16), unrelated to the dAVF or treatment. Five (3.0%) SRS-related complications were reported and resolved during the follow-up period. CONCLUSIONS:SRS was associated with increased symptomatic and mRS Score improvement for low-grade dAVFs compared with conservative management. SRS had a low complication risk and did not appear to alter dAVF obliteration or haemorrhage. Future prospective trials on SRS as a first-line intervention for symptomatic low-grade dAVFs should be considered.