Sustained relief of chronic headache using percutaneous 60-day peripheral nerve stimulation treatment: 12-month results from a multicenter, prospective clinical study

Objective The study aimed to assess the long-term durability of pain relief among patients with cervicogenic headache (CGH) or occipital neuralgia (ON) following percutaneous 60-day peripheral nerve stimulation (PNS) treatment. Background Cervicogenic headache (CGH) and occipital neuralgia (ON) are challenging headache conditions with significant impact on function and quality of life. The present feasibility study initially reported that percutaneous 60-day PNS can reduce headache, facilitating functional improvements such as improved quality of life and reduced neck disability. This work evaluates the durability of clinical outcomes through 12 months within the study cohort. Methods Twenty participants with CGH or ON (and without migraine) received bilateral, percutaneous leads stimulating the occipital nerves. Leads were left indwelling for up to 60 days before being withdrawn. During prospectively defined follow-up through 12 months, participants reported on their occipital pain intensity and pain interference, as well as secondary outcomes. Results Through 12 months, 82% of participants reported sustained, substantial reductions (≥50%) in pain and/or pain interference. Clinically meaningful changes in secondary outcomes, including pain-related neck disability, impact of headache on daily life, and quality of life, were also observed. Results through 3 months on device effectiveness and safety have been previously published. No new device-related adverse events were reported in the follow-up phase of the study among these participants. Conclusions A majority of participants with CGH or ON had sustained relief from pain and pain interference, resulting improvements in function, and reductions in disability through 12 months following a percutaneous 60-day PNS treatment without any new device-related adverse events reported after the 3-month follow-up. These findings support the feasibility for 60-day PNS in the treatment of refractory pain due to CGH or ON.