Allodynia and Sensorial Hypersensitivity in Patients With Migraine: Validation of a Specific Questionnaire
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 14
- 主要终点
- Predictive factors of allodynia/hypersensitivity in subjects with migraine
研究概览
简要总结
Migraine is very frequent (15% of the general population). During attacks, many subjects with migraine have allodynia (pain induced by normally non-painful stimuli), photophobia (hypersensitivity to light), phonophobia (hypersensitivity to sound) or osmophobia (hypersensitivity to odours). The goal of the present study is to validate a new questionnaire made of 4 parts evaluating the presence of these 4 types of hypersensitivity, both during or between migraine attacks. It will allow to look for associations of these 4 symptoms and association of hypersensitivity with patients' or migraine's characteristics.
详细描述
The prevalence of migraine is around 15% worldwide (GBD 2016, Lancet Neurol 2018). During attacks, and even between attacks, especially when migraine frequency is high, many subjects with migraine present with photophobia, phonophobia, osmophobia or allodynia. These symptoms are though to correspond to central sensitization and can be found in animal models of migraine (Boyer et al., Pain 2017; Dallel et al., Cephalalgia 2018).
These 4 symptoms have been studied separately in previous studies but to date, there is no overall questionnaire evaluating these 4 sub-types of hypersensitivity. The investigators have constituted a questionnaire based on previous validated questionnaires that have been translated into French (Lipton et al., 2008 for cutaneous allodynia; Choi et al., 2009 for photophobia), a previous questionnaire validated in French (Khalfa et al, 2002 for phonophobia) and created a few questions for each of the 4 symptoms, including osmophobia.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Subjects fulfilling 2018 international headache society criteria for migraine.
- •Age > 17 years.
- •Written consent.
排除标准
- •Presence of neurological comorbidities that could lead to sensorial or sensitive abnormalities
- •Presence of dermatological comorbidities that could lead to sensorial or sensitive abnormalities
- •Presence of ENT comorbidities that could lead to sensorial or sensitive abnormalities
- •Significant cognitive dysfunction precluding proper completion of the self-administered questionnaire
结局指标
主要结局
Predictive factors of allodynia/hypersensitivity in subjects with migraine
时间窗: baseline
Correlations between scores on specific questionnaires evaluating allodynia/hypersensitivity (cutaneous allodynia with the questionnaire by Lipton et al., 2008, osmophobia with a home-made questionnaire rated from 0 to 4, photophobia with the questionnaire by Choi et al., 2009, phonophobia with the questionnaire by Khalfa et al., 2002), patients characteristics (age, sex, Body mass index, habits, score on the Hospital Anxiety and Depression scale) and migraine characteristics (presence of aura or not, migraine duration in years, migraine frequency in attacks per month, pain intensity during migraine attacks rated from 0 to 4).
次要结局
- Predictive factors of cutaneous allodynia in subjects with migraine(baseline)
- Predictive factors of photophobia in subjects with migraine(baseline)
- Predictive factors of phonophobia in subjects with migraine(baseline)
- Predictive factors of osmophobia in subjects with migraine(baseline)