Successful completion of the previous Phase I study and additional clinical trials has demonstrated that percutaneous peripheral nerve stimulation (PNS) has the potential to provide non-opioid pain relief and improvements in function to injured Service members, Veterans, and civilians. Feedback from military advisors, clinicians, and patients have identified challenges that must be addressed to translate the clinical trial results into military clinical practice and ensure the pain relief, reductions in opioid and non-opioid analgesics, and improvements in function observed in clinical studies are reliably reproduced with the proposed commercial system, enabling Service members to return to active duty. The goal of the present Phase II project is to complete development of a system that meets the needs of military physicians and patients, enabling a wider range of military physicians to easily and correctly deploy the system with minimal training and empowering service members to easily self-manage the therapy and receive effective, non-opioid pain relief. Commercialization of this novel pain-relieving system has the potential to change how pain is managed with a simple drug-free, minimally invasive, safe, and effective treatment option to provide pain relief and an improvement in function in Service members, Veterans, and civilians suffering from disabling pain.
