Ultrasound‐Guided Neuromodulation Is Non‐inferior to Fluoroscopy Approach for Painful Diabetic Neuropathy

OBJECTIVES: To evaluate the efficacy and safety of ultrasound (US)-guided pulsed radiofrequency (PRF) on the lumbar sympathetic ganglion (LSG) for treating painful diabetic neuropathy (PDN). METHODS: A total of 228 patients were retrospectively included. Patients undergoing PRF under US guidance were identified as US cohort. A 1:1 propensity-score matching was performed to select controls that received FL-guided procedures. Primary endpoint was the proportion of patients experiencing at least a 50% reduction in pain at 1 week after treatment. Noninferiority margin was set as 10%. Secondary outcomes included procedure outcomes, lower limb temperature, and scores of numerical rating scale (NRS) pain, neuropathy impairment score-lower limbs (NIS-LL), medical outcomes study sleep scale (MOS-SS), hospital anxiety and depression scale (HADS), and Norfolk quality of life-diabetic neuropathy (Norfolk QoL-DN). RESULTS: In US cohort, 67.8% of patients reported ≥50% pain relief at 1 week, with a mean difference of -0.9% (95% CI: -9.5%, 7.8%) between the 2 cohorts, exceeding the non-inferiority margin. The proportion of patients achieving ≥50% pain relief remained at 65.6% in US cohort versus 66.7% in FL cohort at 4 weeks post-treatment, and 63.3% in US cohort versus 64.0% in FL cohort at 12 weeks post-treatment, with no significant inter-cohort differences at all follow-up time points. Temperature was immediately increased by 5°C in both cohorts. Significant improvements were observed in NRS pain, NIS-LSS, MOS-SS, HADS, and Norfolk QoL-DN scores across the entire 12-week follow-up, with no significant differences between the cohorts (all p > .05). US cohort was associated with fewer number of needle insertions, shorter performance times, less radiation dosages, and a lower incidence of intravascular puncture (all p < .05). CONCLUSIONS: US-guided PRF on the LSG was shown to be non-inferior to procedures under conventional FL guidance for treating PDN. Its unique advantages supported its application in clinical settings.