Rate , Predictors and Outcome of Chronic Migraine

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05079659
Collaborator
(none)
296
1
31.9
9.3

Study Details

Study Description

Brief Summary

Nowadays, headache has been considered as one of the top global disabling medical conditions.1 Migraine is an important type of headache, and one of the chronic multifaceted neuro-inflammatory disorders.2 It is characterized by recurrent throbbing headache pain that typically affects one side of the head, and is often accompanied by nausea and disturbed vision. Migraine headache accounts for 1.4% of all neurological and mental disorders.2 It was reported that the estimated lifetime prevalence of migraine ranged 12%-18%.3 Chronic migraine is defined by the International Classification of Headache Disorders - ICHD-3 as having headaches for ≥ 15 days per month, for ≥ 3 months

, which ≥ 8 days/month are linked to migraine. Chronic migraine affects around 1%-4% of the population and chronic tension-type headache about 2.2%.4 Approximately 25%-50% of those affected also have medication overuse headache, which has a population prevalence of 1%.5 Chronic headache is a severely disabling long-term condition, with higher symptom ,frequency and severity than episodic headache.6

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Nowadays, headache has been considered as one of the top global disabling medical conditions.1 Migraine is an important type of headache, and one of the chronic multifaceted neuro-inflammatory disorders.2 It is characterized by recurrent throbbing headache pain that typically affects one side of the head, and is often accompanied by nausea and disturbed vision. Migraine headache accounts for 1.4% of all neurological and mental disorders.2 It was reported that the estimated lifetime prevalence of migraine ranged 12%-18%.3 Chronic migraine is defined by the International Classification of Headache Disorders - ICHD-3 as having headaches for ≥ 15 days per month, for ≥ 3 months

    , which ≥ 8 days/month are linked to migraine. Chronic migraine affects around 1%-4% of the population and chronic tension-type headache about 2.2%.4 Approximately 25%-50% of those affected also have medication overuse headache, which has a population prevalence of 1%.5 Chronic headache is a severely disabling long-term condition, with higher symptom ,frequency and severity than episodic headache.6 Diagnostic criteria of chronic migraine according to ICHD(7)

    Description:

    Headache occurring on 15 or more days/month for more than 3 months, which, on at least 8 days/month, has the features of migraine headache.

    Diagnostic criteria:
    1. Headache (migraine-like or tension-type-like1) on ≥15 days/month for >3 months, and fulfilling criteria B and C B. Occurring in a patient who has had at least five attacks fulfilling criteria B-D for 1.1 Migraine without aura and/or criteria B and C for 1.2 Migraine with aura
    C. On ≥8 days/month for >3 months, fulfilling any of the following:
    1. criteria C and D for 1.1 Migraine without aura

    2. criteria B and C for 1.2 Migraine with aura

    3. elieved by the patient to be migraine at onset and relieved by a triptan or ergot derivative D Not better accounted for by another ICHD-3 diagnosis.

    Episodic migraine (EM) is characterized by those with migraine who have 0 to 14 headache days per month, while chronic migraine (CM) is characterized by 15 or more headache days per month.

    The relationship between EM and CM is complex. EM progresses to CM at the rate of 2.5% per year [8], and CM often remits to EM (2-year transition rate of 26%) [9].

    Several factors have been associated with migraine chronification (predictors) ; such as age:
    • Age *Sex *Presence of depression *Presence of anxiety

    • sleep disorder *obesity *medication compliance *medication overuse

    • coffee * low income *allodynia *other pain disordes comorbidities.

    Our aims were to identify factors that predict prognosis in patients with chronic Migraine.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    296 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Rate , Predictors and Outcome of Chronic Migraine
    Actual Study Start Date :
    Jan 1, 2021
    Anticipated Primary Completion Date :
    Apr 1, 2023
    Anticipated Study Completion Date :
    Aug 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. To assess remission rate of chronic migraine to episodic migraine [2 years]

      by assessing cases which remit from chronic migraine to episodic migraine according to the criteria of each of them

    Secondary Outcome Measures

    1. to assess potential predictors of chronic migraine [2 years]

      by assessing factors affecting remission of chronic migraine

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 1- both sex 2- all age groups are included 3-history suggestive of chronic migraine 4-accept to participate in the study
    Exclusion Criteria:

    1-presence of neurological disease other than chronic migraine 2-presence of other chronic medical conditions 3-patients refuse to participate in the study .

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    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut university Assiut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mostafa Omar Abdeaziz, DOCTOR, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05079659
    Other Study ID Numbers:
    • chronic migraine
    First Posted:
    Oct 15, 2021
    Last Update Posted:
    Oct 15, 2021
    Last Verified:
    Oct 1, 2021
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 15, 2021