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

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

Treatments tested in this trial

  • Lidocaine 2% and Methylprednisolone 80 mg
  • Placebo

Treatment groups

130 Participants
are divided into 2 treatment groups

Locations

3
Faculty of Medicine Siriraj Hospital, Mahidol University10700, BangkokBangkok, Thailand
Faculty of Medicine, Prince of Songkla University90110, Hat YaiChangwat Songkhla, Thailand
Faculty of Medicine, Chiang Mai University50200, Chiang MaiChiang Mai, Thailand

Sponsors and collaborators

Mahidol University

Lead sponsor

Chiang Mai University, Thailand

Collaborator

Prince of Songkla University

Collaborator

The Royal College of Physicians of Thailand

Collaborator