Occipital Nerve Stimulation for Refractory Occipital Neuralgia: A Multicenter, Randomized, Controlled Trial [StimO Study]

<b>Introduction</b>: Occipital neuralgia [ON] is a primary headache disorder that contributes to a significant proportion of facial pain cases. Occipital neuralgia is an uncommon but disabling headache disorder with an estimated annual incidence of approximately 3.2 per 100,000 individuals. The pathophysiology of ON involves both sensitization of the greater occipital nerve and central mechanisms, including the sensitization of the trigeminocervical pain pathway. <b>Objective</b>: The aim of this study was to evaluate the effectiveness of occipital nerve stimulation (ONS) in patients with refractory occipital neuralgia after six months of treatment. <b>Materials and Methods</b>: StimO is a prospective, open-label, controlled, randomized, and parallel-group study comparing two groups: ONS (occipital nerve stimulation) and OMM (optimized medical management). <b>Results</b>: The percentage change in maximum pain between baseline (D0) and month 6 (M6) showed a significantly greater reduction (<i>p</i> = 0.04) in the ONS group compared to the OMM group. The EQ5D scores revealed that the ONS group had a better quality of life than the OMM group at month 1 (<i>p</i> = 0.01). Medication Quantification Scale (MQS) scores were significantly lower at M1, M3, and M6 [<i>p</i> = 0.03]. However, ONS did not significantly impact anxiety or depression, as assessed by the HAD scale [<i>p</i> > 0.05]. <b>Conclusions</b>: ONS appears to be safe and effective therapy, decreasing pain and medication use and improving quality of life at six months. <b>Trial Registration</b>: The study protocol is registered on ClinicalTrial.gov under the following registration number: NCT03475797.