Chronic Migraine Headache, Combination Therapy, Greater Occipital Nerve Block, OnabotulinumtoxinA
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGOnabotulinumtoxinA
OnabotulinumtoxinA will be injected intramuscularly at standard PREEMPT injection sites for chronic migraine prophylaxis. Total dose per session: 155 units distributed across 31 sites.
PROCEDUREGreater 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
Sponsors
Beni-Suef University
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
randomized, assessor-blinded, controlled trial will include 90 patients diagnosed with chronic migraine. Participants will be randomly assigned to one of three treatment groups: Group 1 (n = 30) will receive BoNT A combined with GONB; Group 2 (n=30) will receive BoNT-A alone; and Group 3 (n = 30) will receive a GONB alone. Randomization will be performed using a computer-generated allocation sequence. Block randomization will be employed to ensure balanced allocation across the groups throughout the enrollment period. Randomization sequence will be generated by an independent investigator who is not involved in participant recruitment, clinical evaluation, intervention administration, or data analysis. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes (SNOSE), This procedure minimizes selection bias and preserves the integrity of the randomization process.
Intervention model description
Participants will be randomly assigned to one of three parallel groups: (1) OnabotulinumtoxinA injections alone, (2) Greater Occipital Nerve (GON) block alone, or (3) combined OnabotulinumtoxinA and GON block. Each group will be followed over a 12-week period to assess changes in headache frequency, severity, duration, and patient-reported quality of life. Adverse events and tolerability will be monitored throughout the study. This design allows direct comparison of single versus combined interventions in patients with chronic migraine.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants achieving ≥50% reduction in monthly migraine days (MMD) | 1 month and 3 months after treatment | Responder rate defined as the proportion of participants achieving a ≥50% reduction in monthly migraine days compared to baseline, as recorded in headache diaries |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to achieve ≥30% reduction in monthly migraine days (MMD) | Up to 3 months after treatment | 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 | Baseline, 1 month, and 3 months after treatment | 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 | Baseline, 1 month, and 3 months after treatment | 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 | Baseline, 1 month, and 3 months after treatment | Change from baseline in Migraine Interictal Burden Scale (MIBS-4) total score (range: 0-12), where higher scores indicate greater interictal burden |
| Change in acute migraine medication use | Baseline, 1 month, and 3 months after treatment | Change from baseline in the frequency of acute migraine medication use as recorded in patient diaries |
| Patient Global Impression of Change (PGIC) | 1 month and 3 months after treatment | Patient Global Impression of Change (PGIC) measured using a 7-point Likert scale (range: 1-7), where higher scores indicate greater improvement |
| Short Assessment of Patient Satisfaction (SAPS) score | 1 month and 3 months after treatment | Patient satisfaction measured using the Short Assessment of Patient Satisfaction (SAPS) total score (range: 0-28), where higher scores indicate greater patient satisfaction |
| Incidence of adverse events | Up to 3 months after treatment | Number and severity of treatment-related adverse events (local and systemic) |
Countries
Egypt
Contacts
CONTACTRakia Mohamed Basiouny, neurology resident
Outcome results
None listed