Validation of a Questionnaire for Allodynia in Migraine.

Migraine Clinical Trial

— Q-MIGAL  

Official title:

Allodynia and Sensorial Hypersensitivity in Patients With Migraine: Validation of a Specific Questionnaire

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04580641
• Other study ID #: RNI 2018 MOISSET (Q-MIGAL)
• Status: Not yet recruiting
• Start date: October 1, 2020
• Est. completion date: September 2021

Study information

• Verified date: September 2020
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre, PharmD
• Phone: 04 73 754 963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: September 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects fulfilling 2018 international headache society criteria for migraine.

• Age > 17 years.

• Written consent.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hyperalgesia
• Migraine
• Migraine Disorders

Intervention

Other:
• Questionnaire
A self-administered questionnaire will be completed by each study subject

Locations

Country	Name	City	State
France	CH d'Annecy, Centre d'Etude et de Traitement de la Douleur	Annecy
France	Cabinet de Neurologie	Clermont-Ferrand
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	CH Emile Roux Le Puy en Velay, Service de Neurologie	Le Puy-en-Velay
France	CHU de Lille, Service de Neurologie	Lille
France	CHU de Lyon, Hôpital Pierre Wertheimer, Service de neurologie fonctionelle et épileptologie	Lyon
France	Assistance Publique - Hôpitaux de Marseille, CHU La Timone, Centre d'Evaluation et Traitement de la Douleur	Marseille
France	CHU de Montpellier, Service de Neurologie	Montpellier
France	CHU de Nantes, Service de Neurologie	Nantes
France	CHU de Nice, Département Evaluation et Traitement de la Douleur	Nice
France	Assistance Publique - Hôpitaux de Paris, CHU Lariboisière, Service de Neurologie	Paris
France	CHU de Rouen, Service de Neurologie	Rouen
France	CH de Vichy, Service de Neurologie	Vichy

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

References & Publications (3)

Choi JY, Oh K, Kim BJ, Chung CS, Koh SB, Park KW. Usefulness of a photophobia questionnaire in patients with migraine. Cephalalgia. 2009 Sep;29(9):953-9. doi: 10.1111/j.1468-2982.2008.01822.x. Epub 2009 Feb 27. — View Citation

Khalfa S, Dubal S, Veuillet E, Perez-Diaz F, Jouvent R, Collet L. Psychometric normalization of a hyperacusis questionnaire. ORL J Otorhinolaryngol Relat Spec. 2002 Nov-Dec;64(6):436-42. — View Citation

Lipton RB, Bigal ME, Ashina S, Burstein R, Silberstein S, Reed ML, Serrano D, Stewart WF; American Migraine Prevalence Prevention Advisory Group. Cutaneous allodynia in the migraine population. Ann Neurol. 2008 Feb;63(2):148-58. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive factors of allodynia/hypersensitivity in subjects with migraine	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).	baseline
Secondary	Predictive factors of cutaneous allodynia in subjects with migraine	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) .	baseline
Secondary	Predictive factors of photophobia in subjects with migraine	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).	baseline
Secondary	Predictive factors of phonophobia in subjects with migraine	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).	baseline
Secondary	Predictive factors of osmophobia in subjects with migraine	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).	baseline