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Explore the clinical evidence

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Clinical studies

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Albright-Trainer 2021: PNS vs SMT in Acute Post-Amputation Pain
Summary
  • RCT compared PNS vs standard medical therapy (SMT) in postoperative period following amputation
  • Greater reductions in pain and opioid use with PNS vs standard care for post-amputation pain (n=16)
  • PNS of sciatic and femoral nerves reduced opioid use and and postsurgical pain at 3 months
Wilson 2014: PNS vs. Usual Care RCT in Hemiplegic Shoulder Pain
Summary
  • Randomized controlled trial of single-lead PNS for shoulder pain, n=25
  • Significantly greater reductions in pain for the PNS group compared to controls
  • Pain reduction was maintained for at least 12 weeks after treatment
Ilfeld 2021: Pilot RCT of PNS for Postoperative Pain
Summary
  • Multicenter RCT: 66 patients randomized to active PNS vs. sham.
  • PNS was significantly lower vs sham (p<0.001) in the first 7 days after surgery.
  • Interference of pain with emotional and physical functioning was reduced with PNS.

Real-world data

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Pingree 2022: Long-Term Follow-Up Survey Following 60-Day PNS
Summary
  • Cross-sectional follow-up survey of SPRINT PNS patients.
  • Most patients reported meaningful pain relief and/or improvement in quality of life at follow up.
  • About one third of survey respondents also reported reducing or stopping medication use.
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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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.
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.
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.

Case reports

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Shaw 2021: PNS for Post-thoracotomy Intercostal Pain Case Reports
Summary
  • Two reports of durable relief (13-14 months) following 60-day PNS of intercostal nerves.
  • 60-Day PNS of intercostal nerves for chronic post-thoractomy intercostal neuralgia.
  • PNS may reduce opioid and nonopioid medication usage in intercostal neuralgia pain.
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.
Fiala 2022: Case Series of Lumbar Level PNS for Low Back Pain
Summary
  • Six reports of PNS targeting the lumbar medial branches for low back pain.
  • Patients reported an average 65% pain reduction with PNS.
  • Medial branch PNS may provide pain relief and functional improvements to those with refractory CLBP.

Posters

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