Durable Outcomes of Percutaneous 60-day Peripheral Nerve Stimulation for Low Back Pain: 5-year Follow-up Survey

Introduction: Low back pain (LBP) is a leading cause of disability worldwide, and treatment often necessitates invasive interventions that carry significant risks and economic burdens. Percutaneous 60-day Peripheral Nerve Stimulation (PNS) is a minimally invasive treatment that can provide durable pain relief enabling functional improvements.¹˒² Building on prior prospective and randomized clinical trials in LBP,³˒⁴ this cross-sectional survey evaluated the durability of improvements among a real-world cohort of patients treated with 60-day PNS for LBP.

Methods: An IRB-approved cross-sectional follow-up survey was administered to patients who previously completed Percutaneous 60-day PNS, having received two leads targeting the lumbar medial branches of the dorsal rami in treatment of LBP, and reported ≥50% pain relief at end of treatment. Patients reporting confounding primary factors contributing to pain at baseline were excluded from survey participation (e.g., radicular pain, neck pain). Survey recipients were contacted 6+ months from PNS implantation. Outcomes assessed included patient-reported percent pain relief and Patient Global Impression of Change in quality of life (QoL), physical function, mood, and sleep. Participants also reported their use or avoidance of other treatments or interventions for LBP since Percutaneous 60-day PNS treatment.

Results: The survey was completed by 603 eligible participants with a mean follow-up of 26 months (range: 6-68 months), including 50 participants who were ≥48 months post-treatment. Overall, 79% (476/603) of survey participants required no subsequent interventions (i.e., radiofrequency ablation (RFA), permanent implant, or surgery) following Percutaneous 60-day PNS. Among survey participants who avoided subsequent interventions, 79% (377/476) reported durable improvements in at least one domain (≥50% pain relief and/or clinically meaningful improvement of QoL, physical function, mood, and/or sleep) at follow-up, including 79% (27/34) of participants that were 48-68 months post-treatment. Among participants without prior lumbar surgery, 91% (337/371) of those who used Percutaneous 60-day PNS wanting to avoid future lumbar surgery successfully avoided surgery at follow-up, and 89% (256/289) of participants interested in using Percutaneous 60-day PNS to avoid a permanent implant avoided permanent implantation through follow-up. Safety outcomes were not assessed in this follow-up survey.

Conclusion: These findings suggest that Percutaneous 60-day PNS can provide durable, multidimensional relief for patients with LBP, with benefits sustained by some for 5+ years. Participants reported long-term improvements in pain and other domains of patient wellness that enabled avoidance of subsequent interventions that included surgery, permanent implants and/or RFA, highlighting the potential of Percutaneous 60-day PNS to serve as a minimally invasive, long-lasting treatment option for LBP.