Phenotype of Headache and Facial Pain in Upper Respiratory Tract Infections

Phenotype of Headache and Facial Pain in Upper Respiratory Tract Infections - a Cross-sectional Study in Primary Care Setting

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:

   1. aetiologic factor (virus),
   2. type of URTI
   3. 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.

Study Overview

• Status: Completed
• Conditions: Upper Respiratory Tract Infections
• Intervention / Treatment: Diagnostic test: Swab test for viral antigens

• Study Type: Observational
• Enrollment (Actual): 223

Contacts and Locations

Study Locations

• Poland
  • Warmińsko-mazurskie
    • Dzwierzuty, Warmińsko-mazurskie, Poland, 12-120
      • Marcin Straburzyński

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with upper respiratory tract infection.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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: Physical examination; Standarised questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with one of the specified pain phenotypes	Percentage of patients with one of the specified pain phenotypes (migraine-like/tension-type-like/trigeminal cephalalgia-like)	A single assessment during primary care physician office 1 day visit.

Collaborators and Investigators

• Sponsor: Marcin Straburzynski

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: November 4, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 6, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Pain; Neurologic Manifestations; Disease Attributes; Infections; Communicable Diseases; Headache; Respiratory Tract Infections; Facial Pain
• Other Study ID Numbers: URTI HA FP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized data will be made available in a public repository after study completion.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No