Phenotype and Burden of a Midfacial Segment Pain

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Facial Pain

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Malta
  • Imsida, Malta
    • Department of Otolaryngology, University of Malta
• Poland
  • Bydgoszcz, Poland
    • Athleticomed - Pain&Headache Treatment Centre
  • Bydgoszcz, Poland
    • Department of Otolaryngology, Head and Neck Surgery and Laryngological Oncology
  • Kraków, Poland
    • Department of Neurology, Jagiellonian University Medical College
  • Orzyny, Poland, 12-120
    • Swiat Zdrowia
  • Oświęcim, Poland
    • Department of Neurology and Restorative Medicine, Health Institute dr Boczarska-Jedynak
  • Warsaw, 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
  • Wrocław, Poland
    • Department of Experimental Dentistry, Wroclaw Medical University
  • Wrocław, Poland
    • Department of Neurology, Wroclaw Medical University
  • Wrocław, Poland
    • MIGRE Polish Migraine Center
• United Kingdom
  • Liverpool, United Kingdom
    • Pain Medicine, Liverpool University Hospitals NHS Foundation Trust
  • Nottingham, United Kingdom
    • Department of Otorhinolaryngology, Nottingham University Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coexisting diagnoses	Other headache/pain-related disorders (assessed with structured questionnaire).	1 month prior to study visit.
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.

Collaborators and Investigators

• Sponsor: Swiat Zdrowia
• Investigators: Principal Investigator: Marcin Straburzyński, PhD, University of Warmia and Mazury in Olsztyn

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: February 24, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 16, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Facial Pain
• Other Study ID Numbers: MFSP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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