Percutaneous Sixty-day Peripheral Nerve Stimulation Provides Durable Relief from Occipital Headache: A Prospective, Single-arm Study

Introduction: Headache disorders associated with pain in the distribution of the occipital nerves, including cervicogenic headache (CGH) and occipital neuralgia (ON), are estimated to affect over 15-20% of patients with chronic headaches.1,2 Sixty-day peripheral nerve stimulation (PNS) treatment has shown positive results for the treatment of various chronic pain conditions, including in the present study where participants with CGH and/or ON underwent 60-days of stimulation of the occipital nerves. As reported previously, 85% of participants had substantial (≥50%) reductions in pain intensity and/or pain interference at the end of treatment with sustained improvements through 3 months in 83%.3 Here, the study cohort was followed through 12 months to assess the durability of relief from pain and pain interference.

Methods: This IRB-approved, prospective single-arm study enrolled participants with occipital head pain due to CGH and/or ON and a lack of migraine-like features as assessed by the ID Migraine screener (score < 2). Participants received percutaneous leads targeting the greater and third occipital nerves near the C2 lamina with stimulation for up to 60 days. Reduction in average pain intensity and pain interference (evaluated by the Brief Pain Inventory Short Form questions 5 and 9, respectively), along with additional outcomes (e.g., Patient Global Impression of Change [PGIC], and Neck Disability Index [NDI]), were evaluated. In this analysis, response to treatment was defined as the proportion of participants with ≥50% reduction in average pain intensity and/or pain interference.

Results: Sixteen participants completed the 12-month follow-up, and 81% (n=13/16) reported substantial relief from pain and/or pain interference. Mean reductions in pain and pain interference of 61% and 74%, respectively, were reported at 12 months among participants who were initially responders at EOT (n=15). All participants reported at least minimally improved quality of life at EOT, and this improvement was sustained in a majority of participants (69%, n=11/16) through 12 months. Among participants who reported at least moderate neck-related disability at baseline (NDI ≥ 15), 71% (n=10/14) reported clinically significant reductions in disability (NDI reduction ≥ 5). All study-related adverse events were non-serious (e.g., skin irritation, itching, post-procedural pain).

Conclusion: These outcomes suggest that 60-day PNS targeting the occipital nerves may provide sustained relief from head pain due to CGH and/or ON. The present analysis provides evidence for pain relief that endures past the treatment duration, and that this relief can facilitate improvements in quality of life and function.