About this trial
Migraine is among the leading causes of disability worldwide. Inappropriate use of acute medications in the setting of primary headache, particularly migraine can result in a debilitating condition known as medication overuse headache (MOH). Treatment of MOH is challenging and the primary therapeutic approach is reducing painkillers which helps decrease the number of headache days. As a part of the detoxification process to discontinue acute medications, bridging therapy is often needed to reduce withdrawal headache. Currently, there are data supporting the use of greater occipital nerve block as a preventive treatment in chronic migraine, but no placebo-controlled trial has evaluated the efficacy of greater occipital nerve block in MOH. Therefore, this research aims to demonstrate the efficacy of greater occipital nerve block in detoxification of migraine patients with MOH. Patients will be recruited from Headache Clinic at 3 centers in Thailand from February 2026 to January 2028. After recruitment, patients will be randomized into 2 groups at a 1:1 ratio using a block of four, namely group A and B. A 5-mL syringe of 2 mL of lidocaine 2% and 2 mL of methylprednisolone 40 mg/mL (80 mg) will be prepared for each patient in group while a 5-mL syringe of 4 mL normal saline will be prepared for each patient in group B. Monthly headache days, duration, severity, acute medication type and number of usage days and relative headache status according to a 5-point Likert scale will be investigated at the 2 weeks, 1st, 2nd and 3rd month, MIDAS at the end of 3rd month.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who have a diagnosis of migraine with medication overuse headache according to ICHD-3 criteria confirmed by a neurologist
Female patients will be screened for pregnancy planning and married female patients must undergo a urine pregnancy test
Disqualifiers
Patients who have other types of headache disorders other than migraine
Patients who have a previous history of allergy to corticosteroid or lidocaine
Patients who had previous skull surgery
Pregnant women
Trial design
Parallel
Treatments tested in this trial
Lidocaine 2% and Methylprednisolone 80 mg
DrugA 4-mL injection containing 2 mL of lidocaine 2% and 2 mL of methylprednisolone 40 mg/mL (80 mg). The injection is administered at the medial third of the distance between the external occipital protuberance and the mastoid process.
Placebo
Other interventionA 4-mL injection of 0.9% Normal Saline administered at the medial third of the distance between the external occipital protuberance and the mastoid process.
Treatment groups
Trial outcomes
Primary outcomes
Percentage of patients with Medication Overuse Headache (MOH)
The percentage of participants diagnosed with Medication Overuse Headache (MOH) according to ICHD criteria.
Secondary outcomes
Percentage of patients achieving 50% improvement in migraine
The percentage of patients with at least a 50% reduction in monthly headache days compared to baseline (month -1).
Change in monthly headache days
The mean change in the number of headache days per month from baseline to month 3.
Change in mean headache severity
The change in mean headache severity scores measured by the Visual Analog Scale (VAS). 0 being no pain and 10 being the worst pain
Change in Migraine Disability Assessment (MIDAS) Score
Evaluation of the change in disability caused by migraines using the MIDAS questionnaire. MIDAS score ranges from 0 to 270 with the higher score, the worse disability.
Sponsors and contacts
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Mahidol University
Lead sponsor
Chiang Mai University, Thailand
Collaborator
Prince of Songkla University
Collaborator
The Royal College of Physicians of Thailand
Collaborator