Objective: To determine if mPNS improved sensation, QoL in subjects with PDN over 90 days.
Methods: Seventy-one subjects with PDN were treated in 6 site RCT comparing safety, effectiveness of mPNS and Conventional Medical Management (CMM). Subjects were randomized 3:1 to mPNS+CMM or Sham+CMM and were followed through 30 days during double-blind phase. At 30 days, Sham+CMM subjects could crossover (CX) to treatment. mPNS+CMM & CX subjects were then followed to 90 days. Secondary endpoints included group summaries of mean change scores from baseline at Day 90 for Visual Analog Scale (VAS) numbness, QOL-DN, PDI, BPI, and DASS.
Results: Fifty subjects were enrolled mPNS+CMM, 21 were enrolled Sham+CMM. Of the 21 in CMM+Sham, 20 elected to crossover at Day 30. Of all subjects in the full analysis set (FAS), 85% completed through Day 90. One adverse event was reported in AT+CMM unrelated to the study device. After 90 days of treatment, mPNS+CMM subjects improved significantly (p<0.05) on all measures (Table). CX subjects also showed significant improvement in numbness, QoL-DN, PDI, and BPI after 90 days, while DASS scores remained stable in all three areas.
Conclusions: mPNS improves sensation and QoL over a 90-day treatment. Because of the non-invasive nature of mPNS and lack of other effective non-invasive treatments for PDN, mPNS should be considered much earlier in treatment algorithm for PDN.
L. Brown: None.
