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Clinical Trials/NCT07568496
NCT07568496Not yet recruitingNot Applicable

Greater Occipital Nerve Block for Migraine With Medication Overuse Headache

Mahidol University3 sites in 1 country130 target enrollmentStarted: May 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
130
Locations
3

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

This is a single-blind study where participants are masked to the treatment assignment, while investigators are aware of the intervention provided.

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Placebo group

Placebo Comparator

Participants receive occipital injection with Normal Saline (0.9% NaCl).

Intervention: Placebo (Other)

Outcomes

Primary Outcomes

Not specified

Secondary Outcomes

  • Change in mean headache severity(Baseline (month -1) and month 3.)
  • Change in Migraine Disability Assessment (MIDAS) Score(Baseline (month -1) and month 3.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Pannathat Soontrapa

Lecturer

Mahidol University

Study Sites (3)

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