Greater Occipital Nerve Block for Migraine With Medication Overuse Headache

NCT07568496 | Not Yet Recruiting

• 1 other identifier: Si321/2026
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Migraine Disorders; Medication Overuse Headache; Greater Occipital Nerve Block

Keywords

GONB; Nerve Block; Detoxification; MOH; Methylprednisolone; Lidocaine

Outcome Measures

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.

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

Secondary Outcomes (4)

• Percentage of patients achieving 50% improvement in migraine

  At the end of month 3.

• Change in monthly headache days

  Baseline (month -1) and month 3.

• Change in mean headache severity

  Baseline (month -1) and month 3.

• Change in Migraine Disability Assessment (MIDAS) Score

  Baseline (month -1) and month 3.

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants receive Greater Occipital Nerve Block (GONB) with 2% Lidocaine and Methylprednisolone.

Drug: Lidocaine 2% and Methylprednisolone 80 mg

Placebo group

PLACEBO COMPARATOR

Participants receive Greater Occipital Nerve Block (GONB) with Normal Saline (0.9% NaCl).

Other: Placebo

Interventions

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.

Intervention group

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.

Placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead
• Chiang Mai University, Thailand: collaborator
• The Royal College of Physicians of Thailand: collaborator
• Prince of Songkla University: collaborator

Study Sites (3)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

Location

Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Faculty of Medicine, Chiang Mai University

Chiang Mai, Chiang Mai, 50200, Thailand

Location

Related Publications (13)

• GBD 2023 Headache Collaborators. Global, regional, and national burden of headache disorders, 1990-2023: a systematic analysis for the Global Burden of Disease Study 2023. Lancet Neurol. 2025 Dec;24(12):1005-1015. doi: 10.1016/S1474-4422(25)00402-8.

  PMID: 41240916 BACKGROUND

• Arab A, Khoshbin M, Karimi E, Saberian G, Saadatnia M, Khorvash F. Effects of greater occipital nerve block with local anesthetic and triamcinolone for treatment of medication overuse headache: an open-label, parallel, randomized, controlled clinical trial. Neurol Sci. 2022 Jan;43(1):549-557. doi: 10.1007/s10072-021-05295-y. Epub 2021 May 4.

  PMID: 33945036 BACKGROUND

• Stewart WF, Lipton RB, Dowson AJ, Sawyer J. Development and testing of the Migraine Disability Assessment (MIDAS) Questionnaire to assess headache-related disability. Neurology. 2001;56(6 Suppl 1):S20-8. doi: 10.1212/wnl.56.suppl_1.s20.

  PMID: 11294956 BACKGROUND

• Inan LE, Inan N, Unal-Artik HA, Atac C, Babaoglu G. Greater occipital nerve block in migraine prophylaxis: Narrative review. Cephalalgia. 2019 Jun;39(7):908-920. doi: 10.1177/0333102418821669. Epub 2019 Jan 6.

  PMID: 30612462 BACKGROUND

• Chowdhury D, Tomar A, Deorari V, Duggal A, Krishnan A, Koul A. Greater occipital nerve blockade for the preventive treatment of chronic migraine: A randomized double-blind placebo-controlled study. Cephalalgia. 2023 Feb;43(2):3331024221143541. doi: 10.1177/03331024221143541.

  PMID: 36739512 BACKGROUND

• Diener HC, Marmura MJ, Tepper SJ, Cowan R, Starling AJ, Diamond ML, Hirman J, Mehta L, Brevig T, Sperling B, Cady R. Efficacy, tolerability, and safety of eptinezumab in patients with a dual diagnosis of chronic migraine and medication-overuse headache: Subgroup analysis of PROMISE-2. Headache. 2021 Jan;61(1):125-136. doi: 10.1111/head.14036. Epub 2020 Dec 13.

  PMID: 33314079 BACKGROUND

• Silberstein SD, Cohen JM, Seminerio MJ, Yang R, Ashina S, Katsarava Z. The impact of fremanezumab on medication overuse in patients with chronic migraine: subgroup analysis of the HALO CM study. J Headache Pain. 2020 Sep 21;21(1):114. doi: 10.1186/s10194-020-01173-8.

  PMID: 32958075 BACKGROUND

• Dodick DW, Doty EG, Aurora SK, Ruff DD, Stauffer VL, Jedynak J, Dong Y, Pearlman EM. Medication overuse in a subgroup analysis of phase 3 placebo-controlled studies of galcanezumab in the prevention of episodic and chronic migraine. Cephalalgia. 2021 Mar;41(3):340-352. doi: 10.1177/0333102420966658. Epub 2020 Nov 3.

  PMID: 33143451 BACKGROUND

• Koonalintip P, Phillips K, Wakerley BR. Medication-Overuse Headache: Update on Management. Life (Basel). 2024 Sep 11;14(9):1146. doi: 10.3390/life14091146.

  PMID: 39337929 BACKGROUND

• Gosalia H, Moreno-Ajona D, Goadsby PJ. Medication-overuse headache: a narrative review. J Headache Pain. 2024 May 31;25(1):89. doi: 10.1186/s10194-024-01755-w.

  PMID: 38816828 BACKGROUND

• Vandenbussche N, Laterza D, Lisicki M, Lloyd J, Lupi C, Tischler H, Toom K, Vandervorst F, Quintana S, Paemeleire K, Katsarava Z. Medication-overuse headache: a widely recognized entity amidst ongoing debate. J Headache Pain. 2018 Jul 13;19(1):50. doi: 10.1186/s10194-018-0875-x.

  PMID: 30003412 BACKGROUND

• Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.

  PMID: 29368949 BACKGROUND

• Shand B, Goicochea MT, Valenzuela R, Fadic R, Jensen R, Tassorelli C, Nappi G; COMOESTAS CONSORTIUM. Clinical and Demographical Characteristics of Patients with Medication Overuse Headache in Argentina and Chile: Analysis of the Latin American Section of COMOESTAS Project. J Headache Pain. 2015;16:83. doi: 10.1186/s10194-015-0561-1. Epub 2015 Sep 18.

  PMID: 26382855 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders; Headache Disorders, Secondary

Interventions

Lidocaine; Methylprednisolone

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Pannathat Soontrapa, M.D.

CONTACT

+6690-568-6388; pannathat.soo@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is a single-blind study where participants are masked to the treatment assignment, while investigators are aware of the intervention provided.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 5, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (3)