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Enrolling by invitationNCT06299995Updated Mar 19, 2024

Phenotype and Burden of a Midfacial Segment Pain

An observational study in Facial Pain, sponsored by Swiat Zdrowia. Enrolling by invitation at 13 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-19.

Sponsored by Swiat Zdrowia · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
200
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

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

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Conditions studied

  • Facial Pain

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03

In context

Facial Pain

182 studies on the registry are indexed under Facial Pain; 61 are open to participants now.

This study's planned enrollment of 200 is above the median of 101 across 42 observational studies indexed under Facial Pain.

Browse Facial Pain studies →

Lead sponsor

Swiat Zdrowia is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Pain characteristics

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

    Time frame: 1 month prior to study visit.

Secondary outcomes

  1. Coexisting diagnoses

    Other headache/pain-related disorders (assessed with structured questionnaire).

    Time frame: 1 month prior to study visit.

  2. 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).

    Time frame: 1 month prior to study visit.

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Study locations

13 sites
  • Department of Otolaryngology, University of Malta
    Imsida, Malta
  • 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
  • Świat Zdrowia
    Orzyny, 12-120, 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
  • 5. Department of Otolaryngology, Centre of Postgraduate Medical Education
    Warsaw, Poland
  • Department of Experimental Dentistry, Wroclaw Medical University
    Wrocław, Poland
  • Department of Neurology, Wroclaw Medical University
    Wrocław, Poland
  • MIGRE Polish Migraine Center
    Wrocław, Poland
  • Pain Medicine, Liverpool University Hospitals NHS Foundation Trust
    Liverpool, United Kingdom
  • Department of Otorhinolaryngology, Nottingham University Hospital
    Nottingham, United Kingdom
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06299995
Lead sponsor
Swiat Zdrowia
Responsible party
Marcin Straburzynski (Dr, University of Warmia and Mazury in Olsztyn) — Principal investigator
First posted
Mar 8, 2024
Start date
Feb 24, 2024
Primary completion
Mar 31, 2025 (estimated)
Completion
Mar 31, 2025 (estimated)
Last update
Mar 19, 2024

Study contacts

Marcin Straburzyński, PhD
principal investigator · University of Warmia and Mazury in Olsztyn

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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