Facial PainNCT06299995
Phenotype and Burden of a Midfacial Segment Pain
An observational study of Facial Pain, run by Swiat Zdrowia at 13 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Pain
- How many people
- 200 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 24 Feb 2024to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients consulting rhinologic, dentistry, headache or pain specialists because of facial pain
Who may be able to join
- 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).
Who cannot join
- 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.
- 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).
- Facial pain that can be attributed to neoplasms.
Show all 10Show fewer
- Facial pain that can be attributed to local infection including post-herpetic neuralgia.
- 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.
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
Poland10 sites
Athleticomed - Pain&Headache Treatment Centre
Bydgoszcz
Department of Otolaryngology, Head and Neck Surgery and Laryngological Oncology
Bydgoszcz
Department of Neurology, Jagiellonian University Medical College
Krakow
Świat Zdrowia
Orzyny, 12-120
Department of Neurology and Restorative Medicine, Health Institute dr Boczarska-Jedynak
Oświęcim
4. Department of Otorhinolaryngology, National Institute of Medicine of the Ministry of the Interior and Administration
Warsaw
5. Department of Otolaryngology, Centre of Postgraduate Medical Education
Warsaw
Department of Experimental Dentistry, Wroclaw Medical University
Wroclaw
Department of Neurology, Wroclaw Medical University
Wroclaw
MIGRE Polish Migraine Center
Wroclaw
United Kingdom2 sites
Pain Medicine, Liverpool University Hospitals NHS Foundation Trust
Liverpool
Department of Otorhinolaryngology, Nottingham University Hospital
Nottingham
About this study
Official title: 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.
Read the detailed description
https://journals.sagepub.com/doi/10.1177/25158163241235642
- Conditions
- Facial Pain
- Medical subject headings
- Facial Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain characteristics
Following pain features will be assessed with structured questionnaire: location, frequency, duration, quality, intensity, accompanying symptoms, provoking/relieving factors.
Measured: 1 month prior to study visit.
Secondary outcomes (2)
Coexisting diagnoses
Other headache/pain-related disorders (assessed with structured questionnaire).
Measured: 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).
Measured: 1 month prior to study visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start24 Feb 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiat Zdrowia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcin Straburzynski, University of Warmia and Mazury in Olsztyn
- Investigators
- Marcin Straburzyński, PhD, Principal investigator, University of Warmia and Mazury in Olsztyn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299995
- Sponsor's protocol ID
- MFSP
- Status last verified
- Mar 2024
- First submitted
- 24 Feb 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional, Multicentre and Multidisciplinary Study Describing Phenotype and Burden of a Midfacial Segment Pain
- ClinicalTrials.gov ID
- NCT06299995
- Acronym / sponsor ID
- MFSP
- Conditions
- Facial Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Swiat ZdrowiaUniversity, hospital or other
- Study start
- 24 Feb 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients consulting rhinologic, dentistry, headache or pain specialists because of facial pain
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (10 listed)
- Facial pain can be attributed to other ICOP-1 diagnosis, apart from tension-type orofacial pain. This means that investigators should exclude especially:
- 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).
- Facial pain that can be attributed to neoplasms.
- Facial pain that can be attributed to local infection including post-herpetic neuralgia.
- History of significant trauma associated with pain onset (pain developed within 7 days from trauma).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain characteristics
Time frame: 1 month prior to study visit.
Following pain features will be assessed with structured questionnaire: location, frequency, duration, quality, intensity, accompanying symptoms, provoking/relieving factors.
2 secondary outcomes
Coexisting diagnoses
Time frame: 1 month prior to study visit.
Pain-related burden and consequences
Time frame: 1 month prior to study visit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: No
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An Open Label Study Assessing REN Treatment in Headache Management in Temporomandibular Disorders
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Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
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RecruitingObservational study
Compare the Intensity of Pain Felt by Children During the Local Anesthesia Procedure to That Perceived by the Accompanying Parent.
Dental Pain, Dental Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcin Straburzyński, PhD principal investigator
University of Warmia and Mazury in Olsztyn
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Facial Pain, run by Swiat Zdrowia at 13 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Poland, United Kingdom, Malta. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain characteristics (time frame: 1 month prior to study visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.