Phenotype and Burden of a Midfacial Segment Pain

March 16, 2024 updated by: Marcin Straburzynski, Swiat Zdrowia

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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 month prior to study visit.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Coexisting diagnoses
Time Frame: 1 month prior to study visit.
Other headache/pain-related disorders (assessed with structured questionnaire).
1 month prior to study visit.
Pain-related burden and consequences
Time Frame: 1 month prior to study visit.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Swiat Zdrowia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marcin Straburzyński, PhD, University of Warmia and Mazury in Olsztyn

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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