Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Chronic Low Back Pain Provides Sustained Relief.

ABSTRACT

OBJECTIVES: The objective of this study was to evaluate the use of percutaneous peripheral nerve stimulation (PNS) for the treatment of chronic low back pain (LBP). Percutaneous PNS offers the potential to provide an effective neuromodulation therapy using a system and fine-wire leads designed specifically for percutaneous use with history of an excellent safety profile. MATERIALS AND METHODS: Subjects with chronic axial LBP received percutaneous PNS leads targeting the medial branch of the dorsal ramus in the region of LBP. Lead placement was guided using ultrasound and confirmed by selective activation of the lumbar multifidus and patient-reported sensations. The percutaneous fine-wire leads remained in place for the 30-day therapy. RESULTS: A majority of subjects reported statistically and clinically significant reductions in both average pain intensity (BPI-5) and worst pain intensity (BPI-3) scores with PNS treatment, which continued long term at the four-month follow-up visit. Subject-reported reductions in pain intensity were substantiated by concomitant and sustained reductions in analgesic medication usage. Subjects also reported clinically significant reductions in patient-centric outcomes of disability (Oswestry Disability Index), pain interference (BPI-9), and patient global impression of change (PGIC). CONCLUSIONS: This work demonstrates the potential value of percutaneous PNS for the treatment of chronic LBP. Improvements in pain, medication, and patient-centric outcomes, which were sustained long term after the removal of PNS leads, demonstrate the significance of this innovative approach to treat chronic LBP.