Transforming the Trial into the Treatment: 60-Day Percutaneous PNS Lead Implant Demonstrates
Sustained Relief of Chronic Pain in a Double-Blind, Placebo-Controlled RCT in Amputees
Gilmore CA, MD,1 Ilfeld BM, MD, MS,2 Rosenow JM, MD,3 Li S, MD,4 Desai MJ, MD, MPH,5 Hunter CW, MD,6 Nader A, MD,3 Mak J, MD,4 Rauck RL, MD,1 Cohen SP, MD,7 Crosby ND, PhD,8 Boggs JW, PhD8
1Center for Clinical Research, Winston-Salem, NC; 2University of California San Diego, San Diego, CA; 3Northwestern University, Chicago, IL; 4Premier Pain Centers, Shrewsbury, NJ; 5International Spine, Pain, and Performance Center, Washington, D.C.; 6Ainsworth Institute of Pain Management, New York, NY; 7Walter Reed National Military Medical Center, Bethesda, MD; 8SPR Therapeutics, Cleveland, OH
Participants: 28 traumatic lower extremity amputees with baseline residual (RLP) and/or phantom limb pain (PLP) ≥ 4 provided written consent and enrolled. Participants were randomized 1:1 to Group 1 or Group 2.
Average Pain Interference
Lead Implantation: Percutaneous PNS leads remotely targeted the sciatic and/or femoral nerves proximal to the regions of RLP and PLP under ultrasound guidance.
Depression: Average reductions in BDI-II score in Group 1 (32% at EOT, 16% at 12 months) were clinically significant and statistically greater than Group 2 at the end of the placebo period (8% increase, p<0.035).
Safety: No serious or unanticipated adverse device effects were reported