Phenotype and Burden of a Midfacial Segment Pain

• Conditions: Facial Pain

• Registration Number: NCT06299995
• Lead Sponsor: Swiat Zdrowia

Brief Summary

The purpose of this study is to describe midfacial segment pain phenotype, burden and comorbidities in a multicentre and multidisciplinary setting. The ultimate goal is a comprehensive description of this type of pain allowing for its implementation in future classifications.

This cross-sectional study is designed to describe midfacial segment pain in a clinical setting. Patients from rhinologic, headache and facial pain or oral medicine/dentistry secondary care centres will be recruited during a one year period. Individuals with other facial pain according to current classification such as sinonasal disorders, neoplasms, local infections, history of significant trauma associated with pain onset will be excluded. Data will be collected through a structured questionnaire covering pain characteristics, coexisting diagnoses, pain-related burden and consequences, physical examination and paranasal sinuses imaging.

Detailed Description

https://journals.sagepub.com/doi/10.1177/25158163241235642

Study Timeline

• Study Start: 2024-02-24
• Study First Submitted: 2024-02-24
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-01
• Study First Posted: 2024-03-08
• Last Update Submitted: 2024-03-16
• Last Update Posted: 2024-03-19
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain characteristics	1 month prior to study visit.	Following pain features will be assessed with structured questionnaire: location, frequency, duration, quality, intensity, accompanying symptoms, provoking/relieving factors.

Secondary Outcome Measures

Name	Time	Method
Coexisting diagnoses	1 month prior to study visit.	Other headache/pain-related disorders (assessed with structured questionnaire).
Pain-related burden and consequences	1 month prior to study visit.	Medications used and their efficacy, consultations in the past, surgical procedures in the past, cost of treatment (assessed with structured questionnaire).

Trial Locations

Locations (13)

Department of Otolaryngology, University of Malta; 🇲🇹 Imsida, Malta

Department of Neurology, Jagiellonian University Medical College; 🇵🇱 Kraków, Poland

Department of Experimental Dentistry, Wroclaw Medical University; 🇵🇱 Wrocław, Poland

Świat Zdrowia; 🇵🇱 Orzyny, Poland

5. Department of Otolaryngology, Centre of Postgraduate Medical Education; 🇵🇱 Warsaw, Poland

Department of Neurology and Restorative Medicine, Health Institute dr Boczarska-Jedynak; 🇵🇱 Oświęcim, Poland

4. Department of Otorhinolaryngology, National Institute of Medicine of the Ministry of the Interior and Administration; 🇵🇱 Warsaw, Poland

MIGRE Polish Migraine Center; 🇵🇱 Wrocław, Poland

Athleticomed - Pain&Headache Treatment Centre; 🇵🇱 Bydgoszcz, Poland

Department of Otolaryngology, Head and Neck Surgery and Laryngological Oncology; 🇵🇱 Bydgoszcz, Poland

Department of Neurology, Wroclaw Medical University; 🇵🇱 Wrocław, Poland

Department of Otorhinolaryngology, Nottingham University Hospital; 🇬🇧 Nottingham, United Kingdom

Pain Medicine, Liverpool University Hospitals NHS Foundation Trust; 🇬🇧 Liverpool, United Kingdom