Is There a Comorbidity Between Migraine and Allergic Rhinitis?

Sponsor
Baskent University (Other)
Overall Status
Completed
CT.gov ID
NCT01845051
Collaborator
(none)
80
3.9

Study Details

Study Description

Brief Summary

The researchers investigated the relationship between migraine and allergy. For this purpose, the researchers designed a controlled study to evaluate nasal symptoms and signs; and to perform Specific Immunoglobulin E (IgE) measurements in migraine patients and healthy subjects. According to these results the prevalence of allergic rhinitis in migraine group was planned to be compared to that of the healthy controls, statistically.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    80 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Study Start Date :
    Nov 1, 2012
    Actual Primary Completion Date :
    Mar 1, 2013
    Actual Study Completion Date :
    Mar 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Migraine group

    Patients diagnosed with migraine

    Healthy group

    Healthy subjects with no migraine as control

    Outcome Measures

    Primary Outcome Measures

    1. Specific Immunoglobulin E (IgE) [1 day]

      Blood samples were taken from study and control group for the determination of Specific IgE panel against six different allergens: (1) fungi, (2) grass pollens, (3) tree pollens, (4) wild herbs, (5) mite 1, (6) mite 2. For all of specific IgE panels, <0,7 RU/ml was negative; and >0,7 RU/ml was Positive.

    2. Nasal Symptom Scores [1 day]

      Symptoms were assessed with a questionnaire for the presence and severity of allergic rhinitis (AR) symptoms on a scale of 0-3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). Symptoms of AR (Nasal discharge, nasal congestion, itching and sneezing) were graded between 0-3.

    Other Outcome Measures

    1. İnferior turbinate color and edema [1 day]

      inferior concha colour (0=natural, 1=pale, 2=bluish and 3=severely pale or bluish) and turbinate edema were assessed during ENT examination on 0-3 scale (0 = no, 1 = mild, 2 = moderate, 3 = severe).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • patients with migraine
    Exclusion Criteria:
    • other neurologic disorders that may contribute to headaches, such as stroke, cerebral palsy, trigeminal neuralgia, and seizure disorder

    • also acute and chronic sinusitis.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Baskent University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Işıl Adadan Güvenç, MD, ENT Specialist, Baskent University
    ClinicalTrials.gov Identifier:
    NCT01845051
    Other Study ID Numbers:
    • CC-01
    First Posted:
    May 3, 2013
    Last Update Posted:
    May 3, 2013
    Last Verified:
    May 1, 2013
    Keywords provided by Işıl Adadan Güvenç, MD, ENT Specialist, Baskent University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 3, 2013