Abstract
Abstract
Objective: Evaluation of the safety and efficacy of a minimally invasive neuromodulation device to treat intractable chronic trunk and limb pain.
To report preliminary results using the wireless design and percutaneous implant system in two diverse conditions.
Methods: Two patients with intractable pain, one following a back surgery and the second one with post herpetic neuralgic pain received treatment. For both subjects, pain was refractory to pain medication, interventional pain procedures and physiotherapy. This modality delivered neuromodulation via a percutaneously implanted electrode remotely controlled by a wireless device. The back pain surgery patient received high frequency dorsal root ganglion (DRG) stimulation to cover the areas that were deemed unsuitable for conventional spinal cord stimulation methods. The second patient had our novel technology for peripheral nerve stimulation (PNS) along the affected intercostal nerve. A Visual Analog Scale (VAS), Oswestry Disability Index (ODI), EQ-5D-5L Quality of Life Questionnaire and Global Impression scale (PGIC) were administered at 3, 5, 8, 12 weeks and 6 months post-implantation.
Results: In both patients there was significant relief of symptoms and reduction in pain medication during the short term follow-up. Pain levels, as reported by both patients at three months post-implantation, decreased by up to 60% with continuously applied stimulation. Stimulation remained paresthesia-free for both subjects while the disability improved by 50%. The procedure as well as the wireless system was tolerated very well and was devoid of any side effects or adverse events.
Conclusion: We have developed a novel, neuromodulation system with a minimally invasive percutaneous implantation suitable for both PNS and DRG stimulation. These preliminary results are very encouraging for the minimally invasive wireless approach for treatment of chronic, intractable back and leg pain. This was safe and also effective.