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Explore the clinical evidence

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Clinical studies

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Li 2026: Per Protocol Analysis of 60-Day PNS for CLBP (RESET RCT)
Summary
  • Post hoc analysis of RESET RCT suggests 60-day PNS treatment delivery is associated with outcomes
  • Other explored variables (e.g., response to MBB) were not significantly associated with outcomes
  • Exploratory cohorts with facetogenic and discovertebral pain features reported positive outcomes
McCormick 2025: RESET RCT Primary Endpoint Results in CLBP
Summary
  • 222 patients with CLBP were randomized to receive 60-day PNS (Group #1) or usual care (Group #2)
  • At 3 months, significantly more patients with 60-day PNS had ≥50% pain relief compared to usual care
  • 60-day PNS produced greater improvements in disability, pain interference, QoL, and analgesic usage
Gutierrez 2025: 60-Day PNS of the Occipital Nerves for Headache
Summary
  • Primary endpoint from a prospective study (n=20) shows headache relief after 60-day PNS
  • 85% of participants at end of treatment had at least 50% reductions in pain and/or pain interference
  • Ongoing follow-up indicates that relief is sustained in a majority of participants

Real-world data

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Sheth 2026: Real-world, cross-sectional survey in low back pain
Summary
  • Follow-up survey reporting real-world outcomes up to 5 years after 60-day PNS in low back pain
  • 79% of those surveyed reported avoiding RFA, permanent implants, and surgery through follow-up
  • Of those avoiding interventions, 79% reported improvement in at least one health domain at follow-up
Aman 2026: Predictors of Success in Shoulder Pain Chart Review
Summary
  • Retrospective chart review shows relief across a variety of shoulder pain types and histories
  • Bimodal PNS® treatment produced greater response rate compared to sensory or motor stimulation alone
  • Similar outcomes in EMR and manufacturer data highlight consistency across data sources
Vorenkamp 2025: Shoulder Pain Follow-up Survey after 60-Day PNS
Summary
  • A majority of responders to 60-day PNS reported sustained shoulder pain relief in a follow-up survey
  • Through up to 5 years, over 80% avoided advancing to additional interventions for shoulder pain
  • A majority of patients interested in deferring shoulder surgery successfully did so after 60-day PNS

Reviews & other publications

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Gill 2025: ASPN Consensus Guidelines for 60-day PNS
Summary
  • First clinical guideline specifically assessing the clinical use of 60-day PNS
  • 60-day PNS received received strong to moderate recommendations for several pain conditions
  • Strong recommendations  made in chronic back pain, postoperative knee pain, and post-amputation pain
Pritzlaff 2024: Review of Studies on PNS for Chronic Pain
Summary
  • Ten studies were identified that prospectively studied PNS for treatment of chronic pain.
  • The studies included patients with shoulder pain, neuropathic pain, or low back pain.
  • Reductions in pain and/or pain interference were consistently reported across all pain types.
Staats 2021: Surveys of Patient Preference for LBP Interventions
Summary
  • Study using two market research surveys of chronic pain patient preferences for LBP interventions.
  • LBP patients preferred temporary interventions to permanently implanted devices.
  • Temporary PNS was the most preferred treatment option over RFA and permanent implants.

Case reports

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Gutierrez 2024: PNS for CRPS Case Reports
Summary
  • SPRINT PNS was used to treat complex regional pain syndrome (CRPS).
  • Three cases of CRPS in the lower extremity with significant and sustained relief of pain.
  • These three cases suggest that 60-day PNS can be a safe and efficacious treatment for CRPS.
Sudek 2023: Retrospective Review of PNS for Cancer Pain
Summary
  • Assessment of 10 cases of successful oncological pain relief using PNS
  • Patient success measured using visual analog scale and quality-of-life metrics
  • Similar relief noted among tumor-related, cancer-associated conditions, and cancer-independent pain
Tate 2023: Technical Case Report on PNS of Musculocutaneous Nerve
Summary
  • Completed ultrasound-guided placement of short-term PNS lead targeting musculocutaneous nerve (MCN)
  • Patient had total pain resolution & coverage in antecubital & radial forearm areas during 60-Day PNS
  • Ultrasound-guided placement of PNS is feasible for targeting the MCN in refractory elbow pain

Posters

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