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Phenotype of Headache and Facial Pain in Upper Respiratory Tract Infections

Sponsor
Marcin Straburzynski (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06127186
Collaborator
(none)
150
Enrollment
1
Location
5
Anticipated Duration (Months)
30.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this longitudinal study is to assess headache and facial pain features in patients with upper respiratory tract infections (URTI). The main question it aims to answer are:

  1. What is the phenotype of headache / facial pain in URTIs

  2. Does the above mentioned phenotype is associated with:

  3. aetiologic factor (virus),

  4. type of URTI

  5. headache/facial pain experienced by patients in the past.

Participants will:

  • answer standardized questions,

  • undergo physical examination,

  • have a swab test performend for antigens of common viruses causing URTI.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Swab test for viral antigens

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Phenotype of Headache and Facial Pain in Upper Respiratory Tract Infections - a Cross-sectional Study in Primary Care Setting
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Study group

Patients reporting for primary care assessment because of URTI.

Diagnostic Test: Swab test for viral antigens
No intervention except for a routine examination and viral testing is planned.
Other Names:
  • Standarised questionnaire
  • Physical examination

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of patients with one of the specified pain phenotypes [A single assessment during primary care physician office 1 day visit.]

      Percentage of patients with one of the specified pain phenotypes (migraine-like/tension-type-like/trigeminal cephalalgia-like)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • URTI confirmed by primary care physician

    • Informed consent to participate in the study

    Exclusion Criteria:

    • chronic or recurrent upper respiratory tract disorders

    • neoplasms

    • signs or symptoms of a serious neurologic or psychiatric disorder.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Marcin Straburzyński Dzwierzuty Warmińsko-mazurskie Poland 12-120

    Sponsors and Collaborators

    • Marcin Straburzynski

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marcin Straburzynski, Principal Investigator, Swiat Zdrowia
    ClinicalTrials.gov Identifier:
    NCT06127186
    Other Study ID Numbers:
    • URTI HA FP
    First Posted:
    Nov 13, 2023
    Last Update Posted:
    Nov 13, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Respiratory Tract Infections
    Headache
    Facial Pain

    Study Results

    No Results Posted as of Nov 13, 2023