Validation of a Questionnaire for Allodynia in Migraine.
- Conditions
- Migraine
- Interventions
- Other: Questionnaire
- Registration Number
- NCT04580641
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 180
- Subjects fulfilling 2018 international headache society criteria for migraine.
- Age > 17 years.
- Written consent.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Subjects with migraine Questionnaire No medical intervention. All included subjects will filled in the questionnaire concerning migraine characteristics and associated symptoms.
- Primary Outcome Measures
Name Time Method Predictive factors of allodynia/hypersensitivity in subjects with migraine 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).
- Secondary Outcome Measures
Name Time Method Predictive factors of cutaneous allodynia in subjects with migraine baseline Correlations between score on the 12-item Allodynia Symptom Checklist (Lipton et al., 2008) (score from 0 to 24 with higher values indicating higher level of allodynia), patients characteristics (age in years, sex, body mass index in kg/m², consumption of alcohol and tobacco, 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) .
Predictive factors of photophobia in subjects with migraine baseline Correlations between scores on two specific questionnaires evaluating photophobia (Choi et al., 2009; binary score for presence or absence of photophobia and home-made questionnaire with score from 0 to 4 with higher values indicating higher level of phonophobia), patients characteristics (age in years, sex, body mass index in kg/m², consumption of alcohol and tobacco, 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).
Predictive factors of phonophobia in subjects with migraine baseline Correlations between scores on a questionnaire evaluating phonophobia (Khalfa et al. 2002, score from 0 to 42 with higher values indicating higher level of phonophobia), patients characteristics (age in years, sex, body mass index in kg/m², consumption of alcohol and tobacco, 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).
Predictive factors of osmophobia in subjects with migraine baseline Correlations between scores on a specific home-made questionnaire evaluating osmophobia (score from 0 to 4 with higher values indicating higher level of osmophobia), patients characteristics (age in years, sex, body mass index in kg/m², consumption of alcohol and tobacco, 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).
Trial Locations
- Locations (14)
Cabinet de Neurologie
🇫🇷Clermont-Ferrand, France
Assistance Publique - Hôpitaux de Marseille, CHU La Timone, Centre d'Evaluation et Traitement de la Douleur
🇫🇷Marseille, France
Assistance Publique - Hôpitaux de Paris, CHU Lariboisière, Service de Neurologie
🇫🇷Paris, France
CHU de Montpellier, Service de Neurologie
🇫🇷Montpellier, France
CHU de Nantes, Service de Neurologie
🇫🇷Nantes, France
CH d'Annecy, Centre d'Etude et de Traitement de la Douleur
🇫🇷Annecy, France
CHU de Clermont-Ferrand, Centre d'Etude et de Traitement de la Douleur
🇫🇷Clermont-Ferrand, France
CHU de Clermont-Ferrand, Service de Neurologie
🇫🇷Clermont-Ferrand, France
CHU de Lille, Service de Neurologie
🇫🇷Lille, France
CHU de Rouen, Service de Neurologie
🇫🇷Rouen, France
CHU de Lyon, Hôpital Pierre Wertheimer, Service de neurologie fonctionelle et épileptologie
🇫🇷Lyon, France
CH Emile Roux Le Puy en Velay, Service de Neurologie
🇫🇷Le Puy-en-Velay, France
CHU de Nice, Département Evaluation et Traitement de la Douleur
🇫🇷Nice, France
CH de Vichy, Service de Neurologie
🇫🇷Vichy, France