SPR to present 12-month RESET trial results for SPRINT PNS in back pain
The randomized RESET trial tested 60-day peripheral nerve stimulation against usual care in chronic low back pain, with 12-month outcomes reaching a public podium for the first time.
Executive Summary
- A completed, registrational randomized trial of a peripheral nerve stimulation device for chronic low back pain reaches a public audience with its full 12-month comparative result for the first time.
- The trial tested a non-surgical, time-limited nerve stimulation approach against usual interventional care, in a field where controlled, industry-sponsored evidence for this device category is thin.
- The trial's completion date moved substantially over its life before finishing, which shapes how the timing of this evidence should be read rather than raising doubt about the result itself.
- The sponsor is presenting two additional analyses of the same trial population alongside the primary readout, pointing to a maturing rather than one-off evidence package.
The presentation
Denise Lester, MD, will present "12 Month Outcomes from a Multicenter Pragmatic Randomized Controlled Trial (RESET): Comparison of 60-Day PNS to Usual Care with Standard Interventional Management in Chronic Low Back Pain" on July 18 at the ASPN Annual Conference in Miami. The abstract was recognized as an ASPN Top Abstract ahead of the session. The trial being presented is NCT04246281, a 230-patient, industry-sponsored, registrational study that compared 60 days of SPRINT PNS treatment to usual care with standard interventional management in chronic low back pain. ASPN+1ASPN 2026 to Feature Three Abstracts on SPRINT® PNSJul 14, 2026The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back PainNCT04246281
The trial
NCT04246281 enrolled 230 patients under an actual enrollment count, started in June 2020, and completed with a primary completion date of April 27, 2026. The registered primary outcome measure is reduction in average pain intensity. The trial moved to Completed status on May 27, 2026, after enrollment closed and the study transitioned to Active, not recruiting in December 2023. No results have been posted to ClinicalTrials.gov for this record as of the conference date. NCT04246281The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back PainNCT04246281
Timeline history
The trial's primary completion date shifted twice: from December 2024 to March 2026 in December 2023, and from March 2026 to April 2026 in June 2025. Those changes reflect an extended, multi-year path to completion for a trial that started enrolling in mid-2020, and the conference presentation now brings the study's registered pain-intensity endpoint to a public audience for the first time since enrollment finished. NCT04246281The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back PainNCT04246281
What surrounds it
Chronic low back pain trials searchable in the same indication skew toward pharmacologic and cell-therapy candidates, including a Phase 3 mesenchymal stem cell trial from Mesoblast and a Phase 3 cannabinoid trial from Vertanical, rather than peripheral nerve stimulation devices. Within the electrical stimulation mechanism class more broadly, the closest programs in the same modality address peripheral nerve injury and ulnar neuropathy rather than chronic low back pain directly. No head-to-head competitive trial against SPRINT PNS in this indication was identified.
The maturing evidence base
The same conference session includes two additional RESET analyses: a post-hoc per-protocol analysis of the medial branch PNS subset presented by Sean Li, MD, and a 5-year real-world durability analysis of the same percutaneous 60-day PNS approach in chronic axial low back pain, both presented by investigators tied to the trial. Together with the primary 12-month readout, this places three related analyses of the same intervention before the same clinical audience in a single conference window, extending rather than duplicating the registered comparative result. ASPNASPN 2026 to Feature Three Abstracts on SPRINT® PNSJul 14, 2026
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