Greater Occipital Nerve Block, Medication Overuse Headache, Migraine Disorders
Conditions
Keywords
GONB, Nerve Block, Detoxification, MOH, Methylprednisolone, Lidocaine
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.
Interventions
DRUGLidocaine 2% and Methylprednisolone 80 mg
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.
OTHERPlacebo
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.
Sponsors
Mahidol University
Chiang Mai University, Thailand
Prince of Songkla University
The Royal College of Physicians of Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with Medication Overuse Headache (MOH) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in mean headache severity | 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 |
| Change in Migraine Disability Assessment (MIDAS) Score | 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. |
| Change in monthly headache days | Baseline (month -1) and month 3. | The mean change in the number of headache days per month from baseline to month 3. |
| Percentage of patients achieving 50% improvement in migraine | 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). |
Countries
Thailand
Contacts
CONTACTPannathat Soontrapa, M.D.
Outcome results
None listed