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Search / Trial NCT06299995

Phenotype and Burden of a Midfacial Segment Pain

Launched by SWIAT ZDROWIA · Mar 1, 2024

Trial Information

Current as of July 28, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

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

Gender

ALL

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.

About Swiat Zdrowia

Swiat Zdrowia is a leading clinical trial sponsor dedicated to advancing medical research and improving patient outcomes through innovative healthcare solutions. With a strong focus on ethical practices and regulatory compliance, Swiat Zdrowia collaborates with a diverse network of healthcare professionals and institutions to conduct robust clinical trials across various therapeutic areas. The organization is committed to fostering scientific excellence and enhancing the quality of life for patients by accelerating the development of new treatments and therapies. Through its comprehensive approach and unwavering commitment to patient safety, Swiat Zdrowia plays a pivotal role in the evolution of modern medicine.

Locations

Imsida, , Malta

Bydgoszcz, , Poland

Bydgoszcz, , Poland

Kraków, , Poland

Orzyny, , Poland

Oświęcim, , Poland

Warsaw, , Poland

Warsaw, , Poland

Wrocław, , Poland

Wrocław, , Poland

Wrocław, , Poland

Liverpool, , United Kingdom

Nottingham, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Marcin Straburzyński, PhD

Principal Investigator

University of Warmia and Mazury in Olsztyn

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported