60-Day PNS vs. Standard Interventional Management for Chronic LBP: RESET RCT 6-Month Results

Thursday, October 23, 2025

2:15 PM - 3:30 PM MT

Location: Session Room - 250 DEF

Poster Presenter(s)

Zachary McCormick, MD

Professor and Vice Chair of PM&R; Chief of Spine and Musculoskeletal Medicine
University of Utah
Salt Lake City, Utah

Co-Author(s)

DL

Denise Lester, MD, Other

Anesthesiologist Pain Physician Addiction Medicine Physician
Hunter Holmes McGuire Medical Center
Richmond, Virginia
Christopher A. Gilmore, MD

President
Carolinas Pain Institute
Winston Salem, North Carolina
SL

Sean Li, MD

Physician Partner
National Spine and Pain Centers
Shrewsbury, New Jersey
JJ

Jessica Jameson, MD

Physician
Axis Spine Center
Coeur D Alene, Idaho
Mehul J. Desai, MD, MPH

Medical Director
International Spine, Pain and Performance Center
Washington, District of Columbia
SC

Steven P. Cohen, MD

Edmond I Eger Professor
Northwestern University Feinberg School of Medicine
Chicago, Illinois
WC

William H. Clark, PhD

Senior Research Engineer
SPR Therapeutics
Cleveland, Ohio
MM

Meredith McGee, PhD

R&D, Senior Manager
SPR Therapeutics
Chapel Hill, North Carolina
JB

Joseph Boggs, PhD

Chief Scientific Officer, Senior Vice President of R&D
SPR
Chapel Hill, North Carolina

Disclosure(s):

Zachary McCormick, MD: No relevant disclosure to display

Christopher A. Gilmore, MD: No relevant disclosure to display

Mehul J. Desai, MD, MPH: No relevant disclosure to display

Background and/or Objectives: Pain management for chronic low back pain (CLBP) includes treatments with varying effectiveness and invasiveness. Percutaneous 60-Day Peripheral Nerve Stimulation (PNS) has been found to produce clinically significant pain relief in prospective clinical trials and real-world evidence. The RESET Clinical Trial is a large Level 1, multicenter randomized controlled trial (RCT) comparing 60-Day PNS to Standard Interventional Management for CLBP.

Design: Patients with CLBP were screened to participate in this IRB-approved RCT (key exclusions: radicular pain, RFA within 6 months, prior surgery) and were randomized (1:1) to Group 1 (Percutaneous 60-Day PNS, SPR® SPRINT® PNS System) or Group 2 (Standard Interventional Management).

Setting : 21 US clinical sites.

Participants : 179 participants (91 in Group 1, 88 in Group 2) completed Primary Endpoint (3 months after start of treatment) and 171 participants (89 in Group 1, 82 in Group 2) completed the 6-month follow-up.

Interventions: Group 1 underwent bilateral PNS lead implantation targeting the lumbar medial branches (stimulation for 6-12 hrs/day, ≤60 days). Group 2 received physician-directed interventions (e.g., ablations, injections, comprehensive care).

Main Outcome Measures: Outcomes included average pain (BPI5) and pain interference (BPI9). The Primary Endpoint evaluated the proportion with ≥50% reduction in BPI5 at 3 months after the start of treatment (⍺=0.05).

Results: At Primary Endpoint, 60-Day PNS was superior to Standard Interventional Management, with a greater proportion experiencing ≥50% pain relief (56% vs 26%; n=90 vs n=88; p< 0.05) and ≥50% reductions in pain interference (64% vs 38%; n=89 vs n=87; p< 0.05). Results were sustained at 6-months (≥50% BPI5 and/or BPI9; 53% vs 36%; n=88 vs n=80; p< 0.05). All adverse events (AEs) were non-serious (most common PNS-related AE: skin irritation or itching at the bandage).

Conclusions: This prospective multicenter RCT demonstrates that Percutaneous 60-Day PNS represents an effective and minimally-invasive treatment option that is clinically superior to Standard Interventional Management in the treatment of CLBP.