Medtronic has enrolled the first patients in a blind, controlled, multicentre, parallel arm study of its peripheral nerve stimulation (PNS), designed for the reduction of chronic, intractable post-surgical back pain.
PNS, which is delivered in patients using the company's neurostimulation system, involves an implant of electrical leads that are connected to a stimulator just under the skin of the lower back.
The stimulator delivers mild electrical impulses to the nerves to interrupt pain signals travelling through the nervous system to the brain.
Designed to assess the safety and efficacy of PNS, the SubQStim IIpivotal trial will enrol 323 patients and randomise them into a treatment or control group for the first three months. Patients will continue to participate in open label follow-up for up to five years.
University of Cincinnati Stereotactic and Functional Neurosurgery associate professor and director and study coordinating investigator George Mandybur said: "The SubQStim II++ pivotal study will provide new information about subcutaneous nerve stimulation as a potentially valuable treatment option for US patients with chronic, intractable back pain who have found insufficient relief with other treatment options."
Medtronic neuromodulation business general manager and vice president Julie Foster said: "Chronic back pain affects a significant number of adults in the US, and if the SubQStim II pivotal trial results are positive, we plan to pursue FDA approval to make this potential treatment option available to patients who may benefit."
Medtronic said it recently initiated the SubQStim I post-market study in Europe, Israel, Australia and Canada to demonstrate the effectiveness of PNS plus optimal medical management (OMM) for low back pain, compared to OMM alone in patients with failed back surgery syndrome (FBSS).
Image: Medtronic corporate HQ in Fridley, Minnesota, US. Photo courtesy of Bobak Ha'Eri.