Phenotype and Burden of a Midfacial Segment Pain

NCT06299995 | Enrolling By Invitation

• 1 other identifier: MFSP
• Study Type: observational
• Target: 200
• Locations: 3 countries
• Sites: 13

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.

Conditions

Facial Pain

Outcome Measures

Primary Outcomes (1)

• Pain characteristics

  Following pain features will be assessed with structured questionnaire: location, frequency, duration, quality, intensity, accompanying symptoms, provoking/relieving factors.

  1 month prior to study visit.

Secondary Outcomes (2)

• Coexisting diagnoses

  1 month prior to study visit.

• Pain-related burden and consequences

  1 month prior to study visit.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients consulting rhinologic, dentistry, headache or pain specialists because of facial pain

You may qualify if:

• The study will include patients consulting rhinologic, oral medicine/dentistry, headache or pain specialists because of facial pain with the following features:
• located at least partially within an area innervated by the second or third division of the trigeminal nerve (both bilateral and unilateral)
• duration of attacks of \> 5 minutes and \< 1 month
• attacks recur for \> 1 month
• at least one pain-free day per month (this pain-free day must be unrelated to the use of abortive or prophylactic treatment modalities).

You may not qualify if:

• Facial pain can be attributed to other ICOP-1 diagnosis, apart from tension-type orofacial pain. This means that investigators should exclude especially:
• facial migraine by ensuring that facial pain is not accompanied by either migraine aura AND/OR nausea/vomiting AND/OR photo- and phonophobia
• persistent idiopathic facial pain by ensuring that the patient experienced a pain-free day or days in the last month (this day or days must be unrelated to use of abortive or prophylactic treatment modalities).
• stomatognathic disorders incl. myofascial orofacial pain (chapter 1-3 of ICOP-1) by ensuring that pain is neither unrelated to jaw motion, function or parafunction nor that signs of temporomandibular disorders are present on physical examination.
• Facial pain with clear rhinogenic cause, such as acute and chronic rhinosinusitis fulfilling both clinical and endoscopic/imaging diagnostic criteria according to the European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS 2020).
• Facial pain that can be attributed to neoplasms.
• Facial pain that can be attributed to local infection including post-herpetic neuralgia.
• History of significant trauma associated with pain onset (pain developed within 7 days from trauma).
• Patients who additionally and independently suffer from primary headaches whose mid-facial pain cannot be explained as orofacial headaches are explicitly not excluded. In other words, patients with migraine are not excluded, as long as their facial pain has no typical migraine features (i.e. nausea/vomiting, photo- AND phonophobia or aura) and facial pain attacks occur independently of headache episodes.
• Also, patients showing signs of mucosal contact points or deviated nasal septum will be included, but the presence of these conditions should be noted in the patients' history. Moreover, patients with Lund-Mackay score of 4 or less can be included in the study, unless any singular sinus can be scored with 2 points.

Sponsors & Collaborators

• Swiat Zdrowia: lead

Study Sites (13)

Department of Otolaryngology, University of Malta

Msida, Malta

Location

Athleticomed - Pain&Headache Treatment Centre

Bydgoszcz, Poland

Location

Department of Otolaryngology, Head and Neck Surgery and Laryngological Oncology

Bydgoszcz, Poland

Location

Department of Neurology, Jagiellonian University Medical College

Krakow, Poland

Location

Świat Zdrowia

Orzyny, 12-120, Poland

Location

Department of Neurology and Restorative Medicine, Health Institute dr Boczarska-Jedynak

Oświęcim, Poland

Location

4. Department of Otorhinolaryngology, National Institute of Medicine of the Ministry of the Interior and Administration

Warsaw, Poland

Location

5. Department of Otolaryngology, Centre of Postgraduate Medical Education

Warsaw, Poland

Location

Department of Experimental Dentistry, Wroclaw Medical University

Wroclaw, Poland

Location

Department of Neurology, Wroclaw Medical University

Wroclaw, Poland

Location

MIGRE Polish Migraine Center

Wroclaw, Poland

Location

Pain Medicine, Liverpool University Hospitals NHS Foundation Trust

Liverpool, United Kingdom

Location

Department of Otorhinolaryngology, Nottingham University Hospital

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Facial Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marcin Straburzyński, PhD

  University of Warmia and Mazury in Olsztyn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 24, 2024
• First Posted: March 8, 2024
• Study Start: February 24, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (10); MA (1); GB (2)