: The primary objective of this prospective, randomized, double-blind, placebo-controlled clinical trial is to evaluate whether repetitive bilateral greater occipital nerve (GON) blockade administered with a local anesthetic (0.5% bupivacaine) significantly reduces headache severity, attack duration, and the number of pain days in female patients with menstrual migraine compared to a placebo group (normal saline). Patients will receive injections twice a month for three months (seven days before the expected onset of menstruation and on the first day of menstruation).
Menstrual migraine (MM) is a highly prevalent and challenging migraine subtype triggered by fluctuations in estrogen and progesterone levels, particularly estrogen withdrawal during the perimenstrual period * This hormonal withdrawal sensitizes the trigeminovascular system and promotes the release of neuropeptides such as calcitonin gene-related peptide (CGRP) * Currently, there are no licensed prophylactic medications specifically developed for MM, making alternative and non-systemic treatments necessary This study investigates the efficacy of a targeted peripheral neuromodulation approach using bilateral greater occipital nerve (GON) blockade. The underlying clinical rationale is that GON blockade timed to the perimenstrual period can modulate nociceptive transmission at the trigeminocervical complex (TCC) and decrease peripheral nerve excitability, thereby limiting the impact of cyclic hormonal fluctuations on the trigeminovascular system . In this trial, a Latin square experimental design is utilized to ensure balanced randomization between the active treatment and placebo groups * Unlike single-injection protocols, the intervention is specifically synchronized with the patients' menstrual cycles, involving injections twice a month over a three-month period (seven days before menstruation and on the first day of menstruation) * By evaluating this specific timing and repetitive protocol, the study aims to establish whether perimenstrual-targeted GON blockade can serve as an effective, non-systemic, short-term prophylactic strategy for patients suffering from this refractory migraine subtype.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Bilateral greater occipital nerve (GON) blockade using a local anesthetic.
Bilateral greater occipital nerve (GON) blockade using placebo (normal saline).
Saglik Bilimleri Universitesi
Istanbul, Istanbul, Turkey (Türkiye)
Change in headache severity evaluated using the Visual Analog Scale (VAS)
Headache severity measured by VAS.
Time frame: Baseline, Month 3, and Month 6
Change in monthly migraine attack frequency
Time frame: Baseline, Month 3, and Month 6
Change in number of headache days per month
Time frame: Baseline, Month 3, and Month 6
Change in mean attack duration in hours
Time frame: Baseline, Month 3, and Month 6
Change in monthly analgesic consumption
Time frame: Baseline, Month 3, and Month 6
Change in Migraine Disability Assessment (MIDAS) scores
Time frame: Baseline, Month 3, and Month 6
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Masking
QUADRUPLE
Enrollment
48