Durable Relief from Occipital Head Pain Following Percutaneous 60-Day Peripheral Nerve Stimulation: 12-Month Outcomes from a Prospective, Single-Arm Study

Background and/or Objectives: Percutaneous 60-day peripheral nerve stimulation (PNS) has shown positive results targeting the occipital nerves, including in the present study where 85% of patients experienced a substantial (≥50%) reduction in pain intensity and/or pain interference at the end of the 60-day treatment with improvements sustained through 3 months. Here, the study cohort was followed through 12 months to assess the durability of relief from pain and pain interference in participants with cervicogenic headache (CGH) or occipital neuralgia (ON).

Design: Participants were enrolled in this IRB-approved, prospective, single arm study across 7 centers.

Setting : Multi-center study conducted at academic medical centers and private practice clinics.

Participants : Twenty participants were enrolled with occipital head pain due to CGH or ON and without migraine.

Interventions: Participants received percutaneous leads targeting the greater and third occipital nerves (GON and TON, respectively) near the C2 lamina with stimulation for up to 60 days.

Main Outcome Measures: Response to treatment was defined in this analysis as the proportion of participants with ≥50% reduction in average pain intensity and/or pain interference.

Results: Among participants followed through 12 months, 81% (n=13/16) continued to report substantial relief from pain and/or pain interference. In a sensitivity analysis, this proportion remained high at 65% (n=13/20) when considering a worse-case scenario where withdrawn participants are considered non-responders, and 75% (n=15/20) when carrying forward the last observed data. Among participants, all study-related adverse events were non-serious (e.g., skin irritation, itching, post-procedural pain), and no new adverse events were reported in the follow-up period (i.e., following lead removal).

Conclusions: These outcomes suggest that 60-day PNS targeting the occipital nerves may provide safe and effective relief from occipital head pain due to CGH and/or ON, with evidence of durable relief through 12 months.