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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
OnabotulinumtoxinA will be injected intramuscularly at standard PREEMPT injection sites for chronic migraine prophylaxis. Total dose per session: 155 units distributed across 31 sites.
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
Beni-Suef University Hospital
Al Fayyum, Egypt
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 frame: 1 month and 3 months after treatment
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
Time frame: Up to 3 months after treatment
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
Time frame: Baseline, 1 month, and 3 months after treatment
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
Time frame: Baseline, 1 month, and 3 months after treatment
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
Time frame: Baseline, 1 month, and 3 months after treatment
Change in acute migraine medication use
Change from baseline in the frequency of acute migraine medication use as recorded in patient diaries
Time frame: Baseline, 1 month, and 3 months after treatment
Patient Global Impression of Change (PGIC)
Patient Global Impression of Change (PGIC) measured using a 7-point Likert scale (range: 1-7), where higher scores indicate greater improvement
Time frame: 1 month and 3 months after treatment
Short Assessment of Patient Satisfaction (SAPS) score
Patient satisfaction measured using the Short Assessment of Patient Satisfaction (SAPS) total score (range: 0-28), where higher scores indicate greater patient satisfaction
Time frame: 1 month and 3 months after treatment
Incidence of adverse events
Number and severity of treatment-related adverse events (local and systemic)
Time frame: Up to 3 months after treatment
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