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.
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
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
Parallel
OnabotulinumtoxinA
DrugOnabotulinumtoxinA will be injected intramuscularly at standard PREEMPT injection sites for chronic migraine prophylaxis. Total dose per session: 155 units distributed across 31 sites.
Greater Occipital Nerve Block (GONB)
Procedure/SurgeryInjection of local anesthetic (2% lidocaine, 1-2 mL per side) around the greater occipital nerve at the occipital region. Procedure performed by trained neurologist
Proportion of participants achieving ≥50% reduction in monthly migraine days (MMD)
Responder rate defined as the proportion of participants achieving a ≥50% reduction in monthly migraine days compared to baseline, as recorded in headache diaries
Time to achieve ≥30% reduction in monthly migraine days (MMD)
Time from treatment initiation to the first occurrence of a ≥30% reduction in monthly migraine days compared to baseline
Change in Headache Impact Test (HIT-6) score
Change from baseline in Headache Impact Test (HIT-6) total score (range: 36-78), where higher scores indicate greater headache-related disability and worse outcomes
Change in Allodynia Symptom Checklist (ASC-12) score
Change from baseline in Allodynia Symptom Checklist (ASC-12) total score (range: 0-24), where higher scores indicate more severe cutaneous allodynia
Change in Migraine Interictal Burden Scale (MIBS-4) score
Change from baseline in Migraine Interictal Burden Scale (MIBS-4) total score (range: 0-12), where higher scores indicate greater interictal burden
Click on the lead sponsor to view all of their trials.
Beni-Suef University
Lead sponsor
Cairo University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
