Botulinum Toxin and/or Greater Occipital Nerve Block for Patients With Chronic Migraine
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Proportion of participants achieving ≥50% reduction in monthly migraine days (MMD)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Arm 1: BoNT-A + GONB
干预措施: OnabotulinumtoxinA (Drug)
Arm 1: BoNT-A + GONB
干预措施: Greater Occipital Nerve Block (GONB) (Procedure)
Arm 3: GONB alone
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.
干预措施: Greater Occipital Nerve Block (GONB) (Procedure)
Arm 2: BoNT-A alone
OnabotulinumtoxinA will be injected intramuscularly at standard PREEMPT injection sites for chronic migraine prophylaxis. Total dose per session: 155 units distributed across 31 sites.
干预措施: OnabotulinumtoxinA (Drug)
结局指标
主要结局
Proportion of participants achieving ≥50% reduction in monthly migraine days (MMD)
时间窗: 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
次要结局
- Time to achieve ≥30% reduction in monthly migraine days (MMD)(Up to 3 months after treatment)
- Change in Headache Impact Test (HIT-6) score(Baseline, 1 month, and 3 months after treatment)
- Change in Allodynia Symptom Checklist (ASC-12) score(Baseline, 1 month, and 3 months after treatment)
- Change in Migraine Interictal Burden Scale (MIBS-4) score(Baseline, 1 month, and 3 months after treatment)
- Change in acute migraine medication use(Baseline, 1 month, and 3 months after treatment)
- Patient Global Impression of Change (PGIC)(1 month and 3 months after treatment)
- Short Assessment of Patient Satisfaction (SAPS) score(1 month and 3 months after treatment)
- Incidence of adverse events(Up to 3 months after treatment)
研究者
Rakia Mohamed Taha Basiouny
Neurology Resident
Beni-Suef University