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Explore the clinical evidence

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Clinical studies

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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
Gilmore 2025: 4-Year Follow Up After 60-day PNS in Low Back Pain
Summary
  • Long-term follow-up survey for prior study shows outcomes in back pain 4 years after 60-day PNS
  • Majority of respondents reported sustained relief of back pain an average of 4.7 years after PNS
  • 70% avoided progression to more costly, invasive, and/or destructive low back pain interventions

Real-world data

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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
Gutierrez 2024: Chart Review of PNS for Chronic Shoulder Pain
Summary
  • Anonymized medical records were reviewed of patients who received SPRINT PNS for shoulder pain.
  • Over 80% of patients reported a substantial (≥50%) reduction in shoulder pain with SPRINT at EOT.
  • Bimodal stimulation produced the greatest percent pain relief.
Valimahomed 2024: RWE of PNS for Chronic Shoulder Pain
Summary
  • Retrospective Real World Evidence (RWE) analysis of 768 patients with chronic shoulder pain.
  • Common PNS lead targets included the suprascapular and/or axillary nerves.
  • Improvements in multiple health domains (e.g., quality of life, physicial function, sleep) at EOT.

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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