Phenotype and Burden of a Midfacial Segment Pain

Facial Pain Clinical Trial

Official title:

Cross-sectional, Multicentre and Multidisciplinary Study Describing Phenotype and Burden of a Midfacial Segment Pain

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06299995
• Other study ID #: MFSP
• Status: Enrolling by invitation
• Start date: February 24, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2024
• Source: Swiat Zdrowia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Facial Pain

Locations

Country	Name	City	State
Malta	Department of Otolaryngology, University of Malta	Imsida
Poland	Athleticomed - Pain&Headache Treatment Centre	Bydgoszcz
Poland	Department of Otolaryngology, Head and Neck Surgery and Laryngological Oncology	Bydgoszcz
Poland	Department of Neurology, Jagiellonian University Medical College	Kraków
Poland	Swiat Zdrowia	Orzyny
Poland	Department of Neurology and Restorative Medicine, Health Institute dr Boczarska-Jedynak	Oswiecim
Poland	4. Department of Otorhinolaryngology, National Institute of Medicine of the Ministry of the Interior and Administration	Warsaw
Poland	5. Department of Otolaryngology, Centre of Postgraduate Medical Education	Warsaw
Poland	Department of Experimental Dentistry, Wroclaw Medical University	Wroclaw
Poland	Department of Neurology, Wroclaw Medical University	Wroclaw
Poland	MIGRE Polish Migraine Center	Wroclaw
United Kingdom	Pain Medicine, Liverpool University Hospitals NHS Foundation Trust	Liverpool
United Kingdom	Department of Otorhinolaryngology, Nottingham University Hospital	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Swiat Zdrowia

Countries where clinical trial is conducted

Malta,  Poland,  United Kingdom, 

Outcome

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