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Clinical studies

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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
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
Goree 2024: RCT of 60-Day PNS for Post-surgical TKA Pain
Summary
  • Multicenter RCT: 52 patients (41 in primary endpoint), 60-day PNS vs. sham for post-TKA pain.
  • Significant Primary Endpoint (≥50% pain relief at EOT): PNS, 60%,vs. Sham, 24% (p=0.028).
  • Significant improvements in function (walking distance), WOMAC, and PGIC QoL with PNS at EOT.

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
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.
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.

Reviews & other publications

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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.
Deer 2021: Proposed Mechanism of Action for Percutaneous PNS
Summary
  • Discusses potential mechanisms by which PNS may provide prolonged reductions in pain.
  • Remote selective targeting with PNS may produce robust comfortable sensations in the area of pain.
  • Prolonged pain relief may occur as a reversal of maladaptive cortical plasticity driven by PNS.
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.
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
Kelly 2023: PNS Retrospective Case Series in Chronic Knee Pain
Summary
  • Retrospective case series (n=14): PNS targeting femoral and saphenous nerves for chronic knee pain
  • 75% reported ≥50% pain reduction; 52% average pain relief at six months post-implantation
  • Demonstrated safety and efficacy with no adverse events

Posters

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