Targeting The Right Pediatric Migraine Patient: A Comorbidity-Oriented Approach To Propranolol Prophylaxis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 488
- 试验地点
- 1
- 主要终点
- Pediatric Migraine Disability Assessment Scale (PedMIDAS) Score
研究概览
简要总结
This observational retrospective cohort study aims to identify clinical and biochemical predictors of response to propranolol prophylaxis in pediatric migraine. A total of 178 children diagnosed with migraine between 2021 and 2023 were evaluated based on headache-related disability (PedMIDAS) and pain severity (VAS). Patients were treated either with behavioral therapy or propranolol (1-3 mg/kg/day) for 3 months.
详细描述
Migraine is a common and disabling neurological condition in the pediatric population, often requiring prophylactic treatment to reduce attack frequency and improve quality of life. Propranolol is frequently prescribed for pediatric migraine prevention; however, treatment response varies considerably among individuals. Understanding the clinical and biochemical factors that predict treatment efficacy could enhance individualized care and reduce unnecessary medication use.
This retrospective cohort study evaluated 178 children diagnosed with pediatric migraine between January 2021 and December 2023 at a tertiary neurology outpatient clinic. All participants were assessed using the Pediatric Migraine Disability Assessment Scale (PedMIDAS) and Visual Analog Scale (VAS) before and after treatment. Patients received either behavioral therapy or oral propranolol (1-3 mg/kg/day) for a duration of 3 months, based on clinical indication and family preference.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 2 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 0-20 years
- •Diagnosed with primary headache according to the International Classification of Headache Disorders, 3rd edition (ICHD-3)
- •Clinical and/or neurological evaluation consistent with primary headache
- •Completed baseline PedMIDAS and VAS assessments
- •Available for 3-month follow-up after initiation of treatment
排除标准
- •Diagnosis of secondary headache, based on clinical history, family history, neurological examination, or laboratory/imaging findings
- •Failure to meet ICHD-3 diagnostic criteria for primary headache
- •Presence of structural brain lesions or other neurological disorders
- •Chronic systemic illness or current use of other migraine prophylactic medications
- •Incomplete data or loss to follow-up within the 3-month period
研究组 & 干预措施
Group 1
Behavioral therapy group
干预措施: Behavioral therapy (Behavioral)
Group 2
Propranolol group
干预措施: Propranolol (Drug)
结局指标
主要结局
Pediatric Migraine Disability Assessment Scale (PedMIDAS) Score
时间窗: Baseline to 3 months after treatment
The primary outcome is the change in PedMIDAS score from baseline to 3 months after treatment. PedMIDAS is a validated questionnaire that quantifies migraine-related disability in children and adolescents. A greater reduction indicates improved clinical response.
次要结局
- Visual Analog Scale (VAS) Pain Scores(Baseline to 3 months after treatment)
研究者
Özge BAYKAN ÇOPUROĞLU
Asst. Prof.
Kayseri University