Focus of the Report: This report focuses on percutaneous peripheral nerve stimulation (PNS) therapy utilizing an external pulse generator for the treatment of adults with intractable chronic pain (pain persisting for ≥ 3 months).

Technology Description: Percutaneous PNS is a nonpharmacological neuromodulation therapy. This technique leverages principles of the gate control theory of pain to selectively stimulate targeted non-nociceptive nerve fibers with the intention of shifting the “gate” to inhibit pain signaling through nociceptive nerve fibers. A minimally invasive percutaneous lead implantation procedure and the use of an external pulse generator were designed to improve upon limitations of older generations of PNS devices.

Controversy: Neuromodulation therapies offer a viable nonpharmacological alternative for both patients with chronic pain and their treating physicians who wish to avoid opioid prescriptions. New generations of PNS appear to have addressed common safety concerns associated with older PNS systems (e.g., need for open surgery, high rates of device-related complications). However, the comparative efficacy and safety of the new generation of PNS systems relative to clinical alternative pain management interventions are still relatively unknown.

Key Questions:

  • Is percutaneous PNS effective for the treatment of intractable chronic pain in adults?

  • How does percutaneous PNS compare with sham PNS, continued conservative pain management, or alternative interventions for the treatment of chronic pain?

  • Is percutaneous PNS safe for patients with chronic pain?

  • Have definitive patient selection criteria been identified for percutaneous PNS therapy?

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