Atypical Orofacial Pain Diagnostics and Differentiation.

NCT ID: NCT04775758

Last Updated: 2021-03-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-27
• Study Completion Date: 2021-08-01

Brief Summary

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.

Conditions

Persistent Idiopathic Facial Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Atypical facial pain group

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.

Group Type: EXPERIMENTAL

Self-evaluating questionnaires

Intervention Type: BEHAVIORAL

Patients are asked to describe their disease (gathering of anamnesis) and to categorize their symptoms according to their strength. Furthermore, patients complete self-evaluating questionnaires: Visual analog scale, Hospital anxiety and depression scale, Pittsburgh sleep quality index, Big five personality traits questionnaire.

iMotions analysis platform

Intervention Type: BEHAVIORAL

While patients' anamnesis and questionnaire indexes are being gathered, iMotions software will gather facial expression analysis, galvanic skin response and heart rate data which will be compared with self-evaluating questionnaires.

Maxillofacial fracture pain group

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.

Group Type: ACTIVE_COMPARATOR

Self-evaluating questionnaires

Intervention Type: BEHAVIORAL

Patients are asked to describe their disease (gathering of anamnesis) and to categorize their symptoms according to their strength. Furthermore, patients complete self-evaluating questionnaires: Visual analog scale, Hospital anxiety and depression scale, Pittsburgh sleep quality index, Big five personality traits questionnaire.

iMotions analysis platform

Intervention Type: BEHAVIORAL

While patients' anamnesis and questionnaire indexes are being gathered, iMotions software will gather facial expression analysis, galvanic skin response and heart rate data which will be compared with self-evaluating questionnaires.

Interventions

Self-evaluating questionnaires

Patients are asked to describe their disease (gathering of anamnesis) and to categorize their symptoms according to their strength. Furthermore, patients complete self-evaluating questionnaires: Visual analog scale, Hospital anxiety and depression scale, Pittsburgh sleep quality index, Big five personality traits questionnaire.

Intervention Type: BEHAVIORAL

iMotions analysis platform

While patients' anamnesis and questionnaire indexes are being gathered, iMotions software will gather facial expression analysis, galvanic skin response and heart rate data which will be compared with self-evaluating questionnaires.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• 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 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lithuanian University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Jan Pavel Rokicki

Administrator in Lithuanian University of Health Sciences Kaunas Clinics, Dentist, Oral Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, , Lithuania

Countries

Lithuania

Other Identifiers

1-VZCH

Identifier Type: -

Identifier Source: org_study_id