Botulinum Toxin and/or Greater Occipital Nerve Block for Patients With Chronic Migraine

Обзор

Chronic migraine is a debilitating neurological disorder that significantly affects patients' daily functioning, mental health, and quality of life. Management typically includes acute and preventive treatments, but effectiveness can be limited due to medication overuse or delayed onset of action. OnabotulinumtoxinA injections provide proven long-term preventive benefits, while Greater Occipital Nerve (GON) block offers rapid but short-term relief. Although both treatments are used individually, evidence on the combined effect is limited. This randomized controlled trial aims to evaluate the efficacy and safety of combining OnabotulinumtoxinA injections with GON block, assessing improvements in headache frequency, severity, and patient quality of life compared to single therapy.

Подробное описание

Chronic migraine is a disabling neurological disorder that affects a significant proportion of the population, leading to substantial functional, psychological, and economic burdens. Despite the availability of acute and preventive treatments, many patients continue to experience frequent headaches due to limited efficacy, delayed onset of action, or medication overuse.

OnabotulinumtoxinA injections have been shown to provide sustained preventive benefits in chronic migraine, reducing headache frequency and improving patient quality of life. Greater Occipital Nerve (GON) block offers rapid relief of headache symptoms, though the effect is typically short-term. While both interventions are used individually, there is limited evidence on the benefits of combining them to achieve both immediate and sustained symptom control.

This randomized controlled trial aims to evaluate the safety and efficacy of combining OnabotulinumtoxinA injections with GON block in adult patients with chronic migraine. Participants will be randomly assigned to one of the following groups: OnabotulinumtoxinA alone, GON block alone, combined therapy, or standard care. Headache frequency, severity, duration, and patient-reported quality of life will be assessed over a 12-week follow-up period. Adverse events and tolerability will also be recorded systematically.

The study is conducted under the supervision of an independent ethics committee to ensure participant safety and adherence to Good Clinical Practice standards. Findings from this study aim to provide evidence on whether an integrated therapeutic approach can offer superior relief and improve long-term outcomes for patients with chronic migraine.

Вмешательства

• Препарат OnabotulinumtoxinA
  OnabotulinumtoxinA will be injected intramuscularly at standard PREEMPT injection sites for chronic migraine prophylaxis. Total dose per session: 155 units distributed across 31 sites.
• Процедура Greater Occipital Nerve Block (GONB)
  Injection of local anesthetic (2% lidocaine, 1-2 mL per side) around the greater occipital nerve at the occipital region. Procedure performed by trained neurologist

Первичные конечные точки

• Proportion of participants achieving ≥50% reduction in monthly migraine days (MMD) [Срок оценки: 1 month and 3 months after treatment]

Вторичные конечные точки (8)

• Time to achieve ≥30% reduction in monthly migraine days (MMD) [Срок оценки: Up to 3 months after treatment]
• Change in Headache Impact Test (HIT-6) score [Срок оценки: Baseline, 1 month, and 3 months after treatment]
• Change in Allodynia Symptom Checklist (ASC-12) score [Срок оценки: Baseline, 1 month, and 3 months after treatment]
• Change in Migraine Interictal Burden Scale (MIBS-4) score [Срок оценки: Baseline, 1 month, and 3 months after treatment]
• Change in acute migraine medication use [Срок оценки: Baseline, 1 month, and 3 months after treatment]
• Patient Global Impression of Change (PGIC) [Срок оценки: 1 month and 3 months after treatment]
• Short Assessment of Patient Satisfaction (SAPS) score [Срок оценки: 1 month and 3 months after treatment]
• Incidence of adverse events [Срок оценки: Up to 3 months after treatment]

Критерии участия

Критерии включения

• Diagnosis of chronic migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3): headache occurring on ≥15 days per month for more than three months, with at least 8 days per month exhibiting migraine features. (International Headache Society, 2013)
• Age > 18 years
• Stable preventive migraine regimen for at least two months prior to recruitment

Критерии исключения

• Co-morbid other
• Prior treatment with BoNT-A or GONB for headache within the previous 3 months.
• Known hypersensitivity to BoNT-A or local anesthetics.
• Cervical anatomical abnormalities that hinder proper localization of injection sites or compromise the safety of the procedure
• Neuromuscular junction disorders (e.g., myasthenia gravis).
• Coagulation disorders or anticoagulant therapy that contraindicates nerve block.
• Significant psychiatric comorbidity that would impair proper pre and post treatment assessment.
• Pregnancy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Beni-Suef University Hospital — Al Fayyum

Публикации

• Arata WH, Midha RK, Varrassi G, Sala K, Plessala MJ, Brodtmann J, Dufrene K, Palowsky Z, Griffin P, Ahmadzadeh S, Shekoohi S, Kaye AD. Occipital nerve block for headaches: a narrative review. J Oral Facial Pain Headache. 2024 Jun;38(2):1-10. doi: 10.22514/jofph.2024.010. Epub 2024 Jun 12. PMID 39801092
• 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
• Ashkenazi A, Matro R, Shaw JW, Abbas MA, Silberstein SD. Greater occipital nerve block using local anaesthetics alone or with triamcinolone for transformed migraine: a randomised comparative study. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):415-7. doi: 10.1136/jnnp.2007.124420. Epub 2007 Aug 6. PMID 17682008
• Ashkenazi A, Levin M. Greater occipital nerve block for migraine and other headaches: is it useful? Curr Pain Headache Rep. 2007 Jun;11(3):231-5. doi: 10.1007/s11916-007-0195-3. PMID 17504651

Идентификаторы

NCT: NCT07535723 · RakiaBasiouny97$

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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