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NCT Number: NCT07568496

Greater Occipital Nerve Block for Migraine With Medication Overuse Headache

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Patients with a history of uncontrolled depression, or psychosis
  • Patients who get or plan to get CGRP-targeted therapies or botulinum toxin injection
  • Patients with an increased risk of bleeding or underlying bleeding disorders

Treatment and study plan

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

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.

Primary outcomes

  1. Percentage of patients with Medication Overuse Headache (MOH)

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

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

Secondary outcomes

  1. Percentage of patients achieving 50% improvement in migraine

    Time frame: At the end of month 3.

    The percentage of patients with at least a 50% reduction in monthly headache days compared to baseline (month -1).

  2. Change in monthly headache days

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

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

  3. Change in mean headache severity

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

    The change in mean headache severity scores measured by the Visual Analog Scale (VAS). 0 being no pain and 10 being the worst pain

  4. Change in Migraine Disability Assessment (MIDAS) Score

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pannathat Soontrapa, M.D.

CONTACT

[email protected]

+6690-568-6388

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • Chiang Mai University, Thailand
  • Prince of Songkla University
  • The Royal College of Physicians of Thailand

Registry information

Acronym: GONB_MOH

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 5, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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