Clinical trial NCT04775758: Atypical Orofacial Pain Diagnostics and Differentiation.
Official title: Atypical Orofacial Pain Diagnostics and Differentiation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Persistent Idiopathic Facial Pain
Keywords: Persistent Idiopathic Facial Pain
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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.

Primary outcomes:
measure: Visual analog scale
timeFrame: Assessment score gathered once (Day 1)
measure: Hospital anxiety and depression scale
timeFrame: Assessment score gathered once (Day 1)
measure: Pittsburgh sleep quality index
timeFrame: Assessment score gathered once (Day 1)
measure: Big Five personality traits
timeFrame: Assessment score gathered once (Day 1)
measure: Galvanic skin response. Valence
timeFrame: Assessment score gathered once (Day 1)
measure: Galvanic skin response. Amplitude
timeFrame: Assessment score gathered once (Day 1)
measure: Galvanic skin response. Peaks/minute
timeFrame: Assessment score gathered once (Day 1)
measure: Facial expression analysis. Duration of positive valence.
timeFrame: Assessment score gathered once (Day 1)
measure: Facial expression analysis. Duration of negative valence.
timeFrame: Assessment score gathered once (Day 1)
measure: Facial expression analysis. Duration of neutral valence.
timeFrame: Assessment score gathered once (Day 1)
measure: Facial expression analysis. Total duration.
timeFrame: Assessment score gathered once (Day 1)
Secondary outcomes:
measure: Heart rate
timeFrame: Assessment score gathered once (Day 1)
measure: Facial expression analysis (raw data)
timeFrame: Assessment score gathered once (Day 1)
measure: Facial expression analysis threshold
timeFrame: Assessment score gathered once (Day 1)
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences Kaunas Clinics
Study officials:
References: