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Explore the clinical evidence

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Clinical studies

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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.
Gilmore 2023: Durable (14 months) relief of LBP with 60-Day PNS
Summary
  • Prospective, multicenter clinical trial of 60-Day PNS of lumbar medial branches for chronic LBP.
  • Clinically meaningful improvements sustained in majority of patients (77%) at 14-month follow-up.
  • 60-Day PNS is a safe, effective 1st-line PNS treatment for recalcitrant CLBP.
Vangeison 2023: 60-Day PNS in Chronic OA Knee Pain Case Series
Summary
  • Retrospective review of 60-Day PNS treatment for nonsurgical chronic osteoarthritic knee pain (n=19)
  • Patients demonstrated improvement in their knee pain from baseline post-temporary PNS explant
  • Temporary PNS may be a treatment for patients with pain who can’t get surgery

Real-world data

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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.
Huntoon 2023: RWD Outcomes with PNS in Chronic Pain
Summary
  • Anonymized records of 6,160 patients implanted with SPRINT PNS were retrospectively reviewed
  • 71% were responders with ≥50% pain relief and/or improvement in quality of life at end of treatment
  • Average and worst pain, percentage pain relief, and global impression of change were also reported

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.
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
Mach 2023: Case series of lumbar PNS for cancer-related back pain
Summary
  • PNS for pain secondary to myeloma-related spinal lesions enabled pain relief for radiation therapy
  • Lumbar medial branch PNS is a promising option for back pain from primary or metastatic tumors
  • Four patients successfully used lumbar PNS for pain relief, allowing them to complete radiation

Posters

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