This multicenter, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of repeated bilateral greater occipital nerve (GON) blockade in patients with chronic migraine and chronic tension-type headache. Greater occipital nerve blockade has been widely used as an interventional treatment for chronic headache disorders; however, evidence regarding its differential efficacy across chronic headache phenotypes remains limited. Participants diagnosed with chronic migraine or chronic tension-type headache according to the International Headache Society criteria were randomized to receive bilateral GON blockade with 0.5% bupivacaine or placebo (0.9% saline). Injections were administered weekly during the first month and monthly during the following two months, resulting in a total of six injections over a three-month treatment period. The primary outcome measure is the change in monthly headache frequency from baseline to Month 1. Secondary outcomes include changes in headache intensity, headache duration, disability scores, and other clinical headache parameters during follow-up.
This multicenter, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of repeated bilateral greater occipital nerve (GON) blockade in patients with chronic migraine and chronic tension-type headache. Greater occipital nerve blockade has been widely used as an interventional treatment for chronic headache disorders; however, evidence regarding its differential efficacy across chronic headache phenotypes remains limited. Participants diagnosed with chronic migraine or chronic tension-type headache according to the International Headache Society criteria were randomized to receive bilateral GON blockade with 0.5% bupivacaine or placebo (0.9% saline). Injections were administered weekly during the first month and monthly during the following two months, resulting in a total of six injections over a three-month treatment period. The primary outcome measure is the change in monthly headache frequency from baseline to Month 1. Secondary outcomes include changes in headache intensity, headache duration, disability scores, and other clinical headache parameters during follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
290
0.5% bupivacaine administered as bilateral greater occipital nerve blockade. Injections were performed using 1.5 mL per side (total 3 mL per session). The procedure was repeated weekly during the first month and monthly during the following two months, resulting in a total of six injections.
0.9% sodium chloride (normal saline) administered as placebo injections for bilateral greater occipital nerve blockade using the same injection volume (1.5 mL per side, total 3 mL) and schedule as the active treatment group.
Bilateral greater occipital nerve blockade performed using the standard injection technique described in the protocol.
Sultan Abdulhamid Han Research and Training Hospital
Istanbul, Istanbul, Turkey (Türkiye)
Change from baseline in monthly number of headache days assessed using patient-reported daily headache diary
Change from baseline in the number of monthly headache days recorded using a patient-reported daily headache diary. A headache day is defined as any calendar day with headache lasting ≥4 hours or requiring acute medication.
Time frame: Baseline and Month 1
Change from baseline in pain intensity measured using the Visual Analog Scale (VAS) for pain
Change from baseline in pain intensity measured using a 10-cm Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates worst imaginable pain.
Time frame: Baseline and Month 3
Change from baseline in total monthly headache duration (hours) assessed using patient-reported daily headache diary
Change from baseline in total monthly headache duration (hours), calculated from patient-reported daily headache diaries as the cumulative number of hours with headache per month.
Time frame: Baseline and Month 3
Change from baseline in headache-related disability measured using the Migraine Disability Assessment (MIDAS) questionnaire
Change from baseline in headache-related disability measured using the Migraine Disability Assessment (MIDAS) questionnaire. Scores range from 0 to 270, with higher scores indicating greater disability.
Time frame: Baseline and Month 3
Incidence of treatment-emergent adverse events (TEAEs)
The number and proportion of participants experiencing treatment-emergent adverse events (TEAEs), assessed through clinical evaluation and patient self-report. Adverse events were categorized by severity and relationship to the intervention.
Time frame: Up to Month 3
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