Atypical Orofacial Pain Diagnostics and Differentiation.

Lithuanian University of Health Sciences

Status: Unknown

Conditions: Persistent Idiopathic Facial Pain

Treatments: Behavioral: Self-evaluating questionnaires; Behavioral: iMotions analysis platform

Study type: Interventional

Funder types: Other

Identifiers

NCT04775758

1-VZCH

Details and patient eligibility

About

Orofacial pain is diagnosed for more than 1.9 percent of general population and for 0.3 percent origin of the facial pain is unknown. Commonly atypical facial pain is treated as a neurological condition without an emotional or psychiatric evaluation. Since atypical pain and mood affective disorders can be related, patients do not receive proper care for this condition.

The aim of this study is to evaluate the relationship between atypical facial pain syndrome and affective mood disorders. We aim to assess patients' with no diagnosed organic pathology tendency towards anxiety, depression, sleep disorders and one of big five personality traits through self-rating questionnaires. We will compare the gathered data with biosensors from iMotions software.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Experimental group The experimental group will consist only of adult patients (18-70years old), who were clinically diagnosed with atypical pain syndrome (G50.1) after all diagnostic measures were performed.

Inclusion criteria:

• Adult patients (18-70years old) who were clinically diagnosed with atypical pain syndrome (G50.1).
• Patients who accepted terms of this research and has signed informed consent form.
• Patients were not previously diagnosed with a psychiatric disorder.

Exclusion criteria:

• A potential participant of the study is not able to comprehend information regarding this study's protocol in both written and verbal forms or fails/refuses to sign an informed consent form.
• Patients who have a diagnosed organic pathology causing orofacial pain.
• Patients who are diagnosed with systemic diseases which may interfere with the study or patients who present with head or neck oncology pathologies.
• Patients who were previously diagnosed with a psychiatric disorder.

Control group Control group will consist of patients who were subjected to maxillofacial fracture (any jaw unilateral fracture). These patients will be involved in this study if they are hospitalized/or have visited Lithuanian University of Health Sciences hospital Kaunas Clinics Department of maxillofacial surgery.

Inclusion criteria:

• Adult patients (18-70year old) who have been diagnosed with orofacial pain due to jaw fracture (S02.3, S02.4, S02.6).
• Patients who have signed an informed consent form.
• Patients who were not previously diagnosed with a psychiatric disorder.

Exclusion criteria:

• A potential participant of the study is not able to comprehend information regarding this study's protocol in both written and verbal forms or fails/refuses to sign an informed consent form.
• Patients who are diagnosed with systemic diseases which may interfere with the study or patients who present with head or neck oncology pathologies.
• Patients who were previously diagnosed with a psychiatric disorder.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Atypical facial pain group

Experimental group

Description:

Patients with clinally diagnosed G50.1 - atypical pain condition after all necessary diagnostic measures are taken to exclude a clear organic pathology (multiple diagnostic tests including MRI, CT and consultations from other specialists). Patients included in this study will undergo self-evaluating questionnaires and objective data analysis with facial expression analysis, galvanic skin response and heart rate. All tests are performed in one visit which will last up to an hour.

Treatment:

Behavioral: iMotions analysis platform

Behavioral: Self-evaluating questionnaires

Maxillofacial fracture pain group

Active Comparator group

Description:

Patients with maxillofacial fracture (S02.3, S02.4, S02.6.) will be subjected into control group. Patients included in this study will undergo self-evaluating questionnaires and objective data analysis with facial expression analysis, galvanic skin response and heart rate. All tests are performed in one visit which will last up to an hour.

Treatment:

Behavioral: iMotions analysis platform

Behavioral: Self-evaluating questionnaires