Hormonal Effects of Puberty-Related Alterations on Pain in Adolescents With Migraine
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Sex Hormones
研究概览
简要总结
The purpose of this research study is to investigate the relationships between sex hormone levels and experimental pain sensitivity and migraine severity will be examined.
详细描述
This study will investigate how puberty and variability in sex hormone levels impact pain sensitivity and migraine symptoms.
Hypothesis 1- A significant reduction in pain sensitivity from early to late pubertal status will be found only for adolescents without but not with migraine during pubertal maturation.
Hypothesis 2- Experimental pain sensitivity will be negatively correlated with testosterone levels in adolescents in both groups (with and without migraine).
Exploratory Hypothesis 1- In adolescents with migraine, higher migraine severity (headache frequency and migraine disability) will be associated with lower testosterone levels.
Exploratory hypothesis 2- Adolescents with migraine will have lower testosterone levels than those without.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 11-15
- •Males and females
- •English speakers
- •Migraine group: diagnosed with migraine
- •Control group: Healthy, with no first degree relative with migraine
排除标准
- •Pregnancy or breastfeeding,
- •Chronic pain (except for migraine for the migraine group), neurological or psychiatric syndromes or syndromes associated with pubertal maturation
- •Use of medications that impact sex hormone levels (i.e., contraceptive pills)
研究组 & 干预措施
Migraine
Adolescents with a migraine diagnosis
干预措施: Thermal stimuli (Device)
Migraine
Adolescents with a migraine diagnosis
干预措施: Pressure stimuli (Device)
Migraine
Adolescents with a migraine diagnosis
干预措施: Pain ratings (Behavioral)
Migraine
Adolescents with a migraine diagnosis
干预措施: Pressure pain thresholds (PPT) (Behavioral)
Migraine
Adolescents with a migraine diagnosis
干预措施: Conditioned pain modulation (CPM) response (Behavioral)
Migraine
Adolescents with a migraine diagnosis
干预措施: PedMIDAS (Pediatric Migraine Disability Assessment) (Behavioral)
Migraine
Adolescents with a migraine diagnosis
干预措施: Hormonal assessment (Diagnostic Test)
Migraine
Adolescents with a migraine diagnosis
干预措施: Pubertal status (Other)
Healthy control
Adolescents without a migraine diagnosis
干预措施: Pain ratings (Behavioral)
Healthy control
Adolescents without a migraine diagnosis
干预措施: Thermal stimuli (Device)
Healthy control
Adolescents without a migraine diagnosis
干预措施: Pressure stimuli (Device)
Healthy control
Adolescents without a migraine diagnosis
干预措施: Pressure pain thresholds (PPT) (Behavioral)
Healthy control
Adolescents without a migraine diagnosis
干预措施: Conditioned pain modulation (CPM) response (Behavioral)
Healthy control
Adolescents without a migraine diagnosis
干预措施: Hormonal assessment (Diagnostic Test)
Healthy control
Adolescents without a migraine diagnosis
干预措施: Pubertal status (Other)
结局指标
主要结局
Sex Hormones
时间窗: Baseline
Testosterone levels
Conditioned pain modulation (CPM) response
时间窗: Baseline
This psychophysical test examine the inhibitory pain modulation efficiency. In this test, pressure pain thresholds (measures by kilopascal) are assessed before and during immersion of the foot in cold water.
次要结局
- Migraine specific measures(Baseline)
- Sex hormone assessments(Baseline)
研究者
Hadas Nahman-Averbuch
Assistant Professor
Washington University School of Medicine