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60-day Percutaneous Peripheral Nerve Stimulation Implant Produces Sustained Relief of Chronic Pain in Amputees: 12-Month Follow-Up of a Double-Blind, Randomized, Placebo-Controlled Trial
Session: MP-02b
Thursday, Nov. 14, 10:00 AM - 12:00 PM
Mardi Gras - B

Please note, medically challenging cases are removed three months after the meeting and scientific abstracts after three years

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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

•Chronic pain and reduced function are significant problems following amputation.
• Peripheral nerve stimulation (PNS) has historically been used to treat a wide range of chronic pain states but has generally required a short trial (4-7 days) followed by implantation of a permanent system for sustained relief.1
•A recent study found that a 60-day PNS treatment provided significant relief of post-amputation pain.2,3 This work presents long-term secondary outcomes from the study up to 12 months following the start of the 60-day treatment.
 

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 

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.

•6/7 (86%) participants in Group 1 with Severe Pain transitioned to Moderate, Mild, or No Pain during and/or after treatment.
•4/5 (80%) participants in Group 1 with Moderate Pain transitioned to Mild or No Pain during and/or after treatment.

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

•Percutaneous PNS delivered for up to 60 days may provide significant and enduring pain relief through one year, enabling subsequent improvements in function and quality of life.
•Potential mechanism includes activation of large diameter sensory fibers that generates non-painful input focally from the region of pain to reverse maladaptive expansion of cortical nociceptive representations.
•A 60-day PNS treatment preceding implantation of a permanent system may avoid the need for a permanent implant in some patients.
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