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| Name | Class |
|---|---|
| Chiang Mai University, Thailand | UNKNOWN |
| Prince of Songkla University | OTHER |
| The Royal College of Physicians of Thailand | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment (GONB) | Active Comparator | Participants receive Greater Occipital Nerve Block (GONB) with 2% Lidocaine + methylprednisolone 80 mg |
|
| Placebo group | Placebo Comparator | Participants receive occipital injection with Normal Saline (0.9% NaCl). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients achieving 50% improvement in migraine | The percentage of patients with at least a 50% reduction in monthly headache days compared to baseline (month -1). | At the end of month 3. |
| Change in monthly headache days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pannathat Soontrapa, M.D. | Contact | +6690-568-6388 | pannathat.soo@mahidol.ac.th |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Siriraj Hospital, Mahidol University | Bangkok | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41240916 | Background | 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. | |
| 33945036 | 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. |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D051271 | Headache Disorders, Secondary |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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This is a single-blind study where participants are masked to the treatment assignment, while investigators are aware of the intervention provided.
|
| 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. |
|
The mean change in the number of headache days per month from baseline to month 3.
| Baseline (month -1) and month 3. |
| Change in mean headache severity | The change in mean headache severity scores measured by the Visual Analog Scale (VAS). 0 being no pain and 10 being the worst pain | Baseline (month -1) and month 3. |
| Change in Migraine Disability Assessment (MIDAS) Score | 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. | Baseline (month -1) and month 3. |
| Faculty of Medicine, Prince of Songkla University | Hat Yai | Changwat Songkhla | 90110 | Thailand |
|
| Faculty of Medicine, Chiang Mai University | Chiang Mai | Chiang Mai | 50200 | Thailand |
|
| 11294956 | 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. |
| 30612462 | 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. |
| 36739512 | 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. |
| 33314079 | 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. |
| 32958075 | 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. |
| 33143451 | 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. |
| 39337929 | 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. |
| 38816828 | 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. |
| 30003412 | 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. |
| 29368949 | 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. |
| 26382855 | 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. |
| D009422 | Nervous System Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |