Greater Occipital Nerve Block for Migraine With Medication Overuse Headache

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMahidol University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Lidocaine 2% and Methylprednisolone 80 mg

    Drug

    A 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 intervention

    A 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

130 Participants
are divided into 2 treatment groups
Group A: Active treatment (GONB)Active comparator 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of patients with Medication Overuse Headache (MOH)

The percentage of participants diagnosed with Medication Overuse Headache (MOH) according to ICHD criteria.

Time frame
At the end of month 1 and month 3 after detoxification.

Secondary outcomes

1

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).

Time frame
At the end of month 3.
2

Change in monthly headache days

The mean change in the number of headache days per month from baseline to month 3.

Time frame
Baseline (month -1) and month 3.
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

Time frame
Baseline (month -1) and month 3.
4

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.

Time frame
Baseline (month -1) and month 3.

Other outcomes

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