Safety and Efficacy of Occipital Nerves Stimulation for the Treatment of Chronic Migraines: Randomized, Double-blind, Controlled Single-center Experience
Abstract
BACKGROUND: A recent multicenter study presented 52-week safety and efficacy results from an open-label extension of a randomized, sham-controlled trial for patients with chronic migraine (CM) undergoing peripheral nerve stimulation of the occipital nerves. We present the data from a single center of 20 patients enrolled at the Cleveland Clinic's Pain Management Department.
METHODS: In this single center, 20 patients were implanted with a neurostimulation system, randomized to an active or control group for 12 weeks, and received open-label treatment for an additional 40 weeks. Outcomes collected included number of headache days, pain intensity, Migraine Disability Assessment (MIDAS), Zung Pain and Distress (PAD), direct patient reports of headache pain relief, quality of life, satisfaction, and adverse events (AEs).
RESULTS: Headache days per month were reduced by 8.51 (±9.81) days (P < 0.0001). The proportion of patients who achieved a 30% and 50% reduction in headache days and/or pain intensity was 60% and 35%, respectively. MIDAS and Zung PAD were reduced for all patients. Fifteen (75%) of the 20 patients at the site reported at least one AE. A total of 20 AEs were reported from the site.
CONCLUSION: Our results support the 12-month efficacy of 20 CM patients receiving peripheral nerve stimulation of the occipital nerves in this single-center trial.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 20 participants or records.
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