Longitudinal Outcomes of Bilateral and Unilateral Proximal Greater Occipital Nerve Pulsed Radiofrequency in Migraine: A Prospective Randomized Controlled Trial
Abstract
Background and Objectives: Greater occipital nerve pulsed radiofrequency (GON-PRF) is an effective neuromodulatory treatment for migraine; however, evidence directly comparing unilateral and bilateral approaches remains limited. This prospective randomized controlled trial compared the clinical efficacy of ultrasound-guided proximal GON-PRF performed unilaterally versus bilaterally at the C2 level in patients with migraine. Materials and Methods: A total of 187 patients were randomized to receive unilateral (n = 91) or bilateral (n = 96) ultrasound-guided proximal GON-PRF without concomitant local anesthetic or corticosteroids. Per-protocol analyses included 78 and 88 participants in the unilateral and bilateral groups, respectively. The primary outcome was the change in monthly headache days (MHD) from baseline to 6 months. Secondary outcomes included Visual Analog Scale (VAS) scores, acute medication days (AMD), Headache Impact Test-6 (HIT-6) scores, Migraine Disability Assessment (MIDAS) grades, and Global Perceived Effect (GPE) scores. Longitudinal outcomes were analyzed using multivariable Generalized Estimating Equations (GEE). Results: Of the 187 randomized participants, 166 completed the 6-month follow-up and were included in the per-protocol analysis. Both groups demonstrated significant improvements in all outcomes throughout follow-up (all p < 0.001). At month 6, the Bilateral Group showed lower MHD values (median [IQR]: 7.0 [6.0] vs. 10.0 [6.0], p = 0.030), a…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 187 participants or records.
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