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Explore the clinical evidence

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Clinical studies

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Ilfeld 2019: Feasibility of PNS in Post-TKA Pain Management
Summary
  • Prospective study: 7 subjects, femoral and sciatic PNS for post-TKA pain
  • Pain scores <4/10  in 86% of subjects and 57% discontinued opioids during the first week
  • Functional recovery: average 6MWT improvement of 26% by 12 weeks; no device-related infections
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
Gilmore 2020: PNS in Post-Amputation Pain RCT 12-mo Follow-Up
Summary
  • Placebo-controlled RCT of PNS for chronic neuropathic pain following lower extremity amputation
  • Majority had substantial reductions in pain 12 months after start of PNS, n=9
  • 60-day PNS can provide significant long-term relief of chronic pain following amputation

Real-world data

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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
Naidu 2022: Real-World Analysis of Delayed Response to PNS
Summary
  • 60-day PNS treatment can help identify delayed responders and non-responders to stimulation
  • 38% of patients (n=747) were either delayed responders (31%) or delayed non-responders (7%)
  • 60-day PNS may help inform treatment strategies to optimize outcomes and cost for patients
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.

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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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
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
Haider 2023: Case Report of Cervical PNS in Arthritic Neck Pain
Summary
  • Patient experienced 2 years of severe chronic pain following a work-related neck injury.
  • Physical therapy and over-the-counter pain medications did not provide sufficient relief.
  • PNS targeting the nerves of the cervical spine produced 50% reduction in pain at 2 months.

Posters

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