A Randomized Controlled Trial Comparing the Efficacy of Supratrochlear and Greater Occipital Nerve Blocks to Botulinum Toxin A in the Management of Chronic Migraine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Reduction in Monthly Migraine Days
研究概览
简要总结
The goal of this clinical trial is to determine whether nerve block injections (specifically, supratrochlear and greater occipital nerve injections) are as effective as Botulinum toxin A (Botox) injections in treating chronic migraine in adults.
The main questions it aims to answer are:
- Do nerve block injections reduce the number of monthly migraine days compared to baseline?
- Are there any differences in the frequency of migraine-related symptoms between the nerve block and Botox treatment groups?
- Which treatment leads to higher patient satisfaction and improved quality of life?
Participants in this study will:
- Receive either nerve block injections or Botox injections every 12 weeks.
- Visit the clinic once every month for follow-ups and assessments.
- Maintain a headache diary to record the frequency and severity of their migraines and any adverse effects experienced.
- Researchers will compare the outcomes of the two groups to determine if one treatment is superior in terms of efficacy and patient satisfaction.
详细描述
This randomized controlled trial aims to assess the comparative efficacy of supratrochlear and greater occipital nerve block injections versus Botulinum toxin A (Botox) injections in the management of chronic migraine. Chronic migraine, characterized by headaches on fifteen or more days per month, significantly impacts quality of life and productivity. Effective management strategies are crucial for improving patient outcomes.
Study Design: Participants will be randomly assigned to one of two treatment arms:
- Nerve block injections group, receiving supratrochlear and greater occipital nerve injections with a combination of local anesthetics and corticosteroids.
- Botox injections group, receiving the standard Botox treatment protocol recommended for chronic migraine.
Each participant will receive their assigned treatment once every 12 weeks for a total of 6 months.
The primary endpoint will be the reduction in the number of migraine days per month from baseline to the end of the treatment period. Secondary endpoints will include changes in migraine severity, frequency of acute medication use, patient-reported outcomes on pain and migraine-related disability, and treatment safety and tolerability.
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
Outcomes assessors will be blinded to treatment allocation to ensure unbiased evaluation of efficacy and safety outcomes.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 65 years.
- •Diagnosis of chronic migraine, defined as having headaches on 15 or more days per month for more than three months, with at least 8 of those days meeting criteria for migraine.
- •Ability to provide informed consent and comply with study requirements.
- •No changes in prophylactic migraine medications in the last 3 months.
排除标准
- •History of allergy or hypersensitivity to local anesthetics or Botulinum toxin.
- •Previous nerve block or Botox treatment within the last 6 months.
- •Significant comorbid psychiatric or neurological disorders that could interfere with study participation or evaluation.
- •Pregnancy or breastfeeding.
- •Contraindications to either treatment as per product labels.
研究组 & 干预措施
Nerve Block Therapy
Participants in this group will receive supratrochlear and greater occipital nerve injections consisting of a combination of local anesthetics and corticosteroids. Injections will be administered once every 12 weeks for a total of 6 months.
干预措施: Nerve Block Injections (Procedure)
Botulinum Toxin A (Botox) Therapy
Participants in this group will receive Botulinum toxin A (Botox) injections according to the standard PREEMPT injection protocol for chronic migraine. Injections will be administered once every 12 weeks for a total of 6 months.
干预措施: Botulinum Toxin A (Drug)
结局指标
主要结局
Reduction in Monthly Migraine Days
时间窗: Baseline, 3 months, 6 months post-procedure
The primary outcome is the reduction in the number of migraine days per month. This measure assesses the effectiveness of nerve block injections versus Botox injections in decreasing the frequency of migraine days from baseline to the end of the treatment period.
次要结局
- Patient Satisfaction and Quality of Life(Baseline, 3 months, 6 months post-procedure)
- Adverse Events(Throughout the study period (6 months))
- Change in Migraine Severity(Baseline, 3 months, 6 months post-procedure)
- Frequency of Acute Medication Use(Baseline, 3 months, 6 months post-procedure)
研究者
Ahmed Awad Bessar
Assistant Professor of Diagnostic and Interventional Radiology
Zagazig University