Clinical trial NCT06299995: Phenotype and Burden of a Midfacial Segment Pain
Official title: Cross-sectional, Multicentre and Multidisciplinary Study Describing Phenotype and Burden of a Midfacial Segment Pain
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Facial Pain
Lead sponsor: Swiat Zdrowia
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients consulting rhinologic, dentistry, headache or pain specialists because of facial pain

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

Eligibility criteria: Inclusion criteria

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).

Exclusion criteria

1. 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.
2. 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).
3. Facial pain that can be attributed to neoplasms.
4. Facial pain that can be attributed to local infection including post-herpetic neuralgia.
5. 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.

Primary outcomes:
measure: Pain characteristics
timeFrame: 1 month prior to study visit.
Secondary outcomes:
measure: Coexisting diagnoses
timeFrame: 1 month prior to study visit.
measure: Pain-related burden and consequences
timeFrame: 1 month prior to study visit.
Other outcomes:
Locations:
city: Imsida
country: Malta
facility: Department of Otolaryngology, University of Malta
city: Bydgoszcz
country: Poland
facility: Athleticomed - Pain&Headache Treatment Centre
city: Bydgoszcz
country: Poland
facility: Department of Otolaryngology, Head and Neck Surgery and Laryngological Oncology
city: Kraków
country: Poland
facility: Department of Neurology, Jagiellonian University Medical College
city: Orzyny
country: Poland
facility: Świat Zdrowia
city: Oświęcim
country: Poland
facility: Department of Neurology and Restorative Medicine, Health Institute dr Boczarska-Jedynak
city: Warsaw
country: Poland
facility: 4. Department of Otorhinolaryngology, National Institute of Medicine of the Ministry of the Interior and Administration
city: Warsaw
country: Poland
facility: 5. Department of Otolaryngology, Centre of Postgraduate Medical Education
city: Wrocław
country: Poland
facility: Department of Experimental Dentistry, Wroclaw Medical University
city: Wrocław
country: Poland
facility: Department of Neurology, Wroclaw Medical University
city: Wrocław
country: Poland
facility: MIGRE Polish Migraine Center
city: Liverpool
country: United Kingdom
facility: Pain Medicine, Liverpool University Hospitals NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Department of Otorhinolaryngology, Nottingham University Hospital
Study officials:
affiliation: University of Warmia and Mazury in Olsztyn
name: Marcin Straburzyński, PhD
role: PRINCIPAL_INVESTIGATOR
References: