search
Back to results

Atypical Orofacial Pain Diagnostics and Differentiation.

Primary Purpose

Persistent Idiopathic Facial Pain

Status
Unknown status
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Self-evaluating questionnaires
iMotions analysis platform
Sponsored by
Lithuanian University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Persistent Idiopathic Facial Pain focused on measuring Persistent Idiopathic Facial Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lithuanian University of Health Sciences Kaunas Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Atypical facial pain group

Maxillofacial fracture pain group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Visual analog scale
Patients evaluate their spontaneous episodic pain before assessing self-evaluating questionnaires. Patient pain will be assessed using a visual analogue scale of 0-10, zero being no pain, ten being an unbearable/unimaginable pain. The higher score may lead to a possibilty of developing mood disorders.
Hospital anxiety and depression scale
The Hospital anxiety and depression scale is a fourteen-item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.
Pittsburgh sleep quality index
The Pittsburgh Sleep Quality Index contains 19 self-rated questions which measures seven aspects of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points (0 indicates no difficulty, while 3 indicates severe difficulty). The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality).
Big Five personality traits
Big five personality traits questionnaire is a 25-item questionnaire compiled from Goldberg et al. 1999. Respondent chooses between a pair of adjectives and chooses an according score from one to seven. All personality dimensions are evaluated separately from specific pairs of adjectives and sum of these pairs scores. Lithuanian version is adapted from A.Bunevičius (2006).
Galvanic skin response. Valence
Galvanic skin response peaks (countable) either total or within positive, negative and neutral condition valence.
Galvanic skin response. Amplitude
Galvanic skin response is measured in microsiemens. Sudden rise in skin conductivity is called a peak. Peak amplitudes (in microsiemens) will be recorded and analysed. Average amplitude of peaks, either total or within positive, negative and neutral valence.
Galvanic skin response. Peaks/minute
Peaks/minute (normalized measure) either total or within positive, negative and neutral valence.
Facial expression analysis. Duration of positive valence.
Facial expression analysis determines the respondents' valence (negative, positive or neutral). The duration of positive valence (more than 30 percent threshold) will be assessed seconds.
Facial expression analysis. Duration of negative valence.
Facial expression analysis determines the respondents' valence (negative, positive or neutral), the duration of negative valence (less than 30 percent threshold) will be assessed in seconds.
Facial expression analysis. Duration of neutral valence.
Facial expression analysis determines the respondents' valence (negative, positive or neutral). The duration of neutral valence (from -30 percent to 30 percent threshold) will be assessed in seconds.
Facial expression analysis. Total duration.
Facial expression analysis determines the respondents' valence (negative, positive or neutral). A total duration of the record (measuring time in seconds) will be used.

Secondary Outcome Measures

Heart rate
Using optical pulse sensors we aim to register beats per minute throughout the whole participation of the respondents.
Facial expression analysis (raw data)
Average of probability scores for each emotion and facial expression.
Facial expression analysis threshold
Fraction of time that an emotion or facial expression crosses the threshold of 30 percent.

Full Information

First Posted
February 21, 2021
Last Updated
February 25, 2021
Sponsor
Lithuanian University of Health Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT04775758
Brief Title
Atypical Orofacial Pain Diagnostics and Differentiation.
Official Title
Atypical Orofacial Pain Diagnostics and Differentiation.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 27, 2021 (Anticipated)
Primary Completion Date
July 22, 2021 (Anticipated)
Study Completion Date
August 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lithuanian University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Idiopathic Facial Pain
Keywords
Persistent Idiopathic Facial Pain

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atypical facial pain group
Arm Type
Experimental
Arm 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.
Arm Title
Maxillofacial fracture pain group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Self-evaluating questionnaires
Intervention Description
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
Intervention Name(s)
iMotions analysis platform
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual analog scale
Description
Patients evaluate their spontaneous episodic pain before assessing self-evaluating questionnaires. Patient pain will be assessed using a visual analogue scale of 0-10, zero being no pain, ten being an unbearable/unimaginable pain. The higher score may lead to a possibilty of developing mood disorders.
Time Frame
Assessment score gathered once (Day 1)
Title
Hospital anxiety and depression scale
Description
The Hospital anxiety and depression scale is a fourteen-item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.
Time Frame
Assessment score gathered once (Day 1)
Title
Pittsburgh sleep quality index
Description
The Pittsburgh Sleep Quality Index contains 19 self-rated questions which measures seven aspects of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points (0 indicates no difficulty, while 3 indicates severe difficulty). The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality).
Time Frame
Assessment score gathered once (Day 1)
Title
Big Five personality traits
Description
Big five personality traits questionnaire is a 25-item questionnaire compiled from Goldberg et al. 1999. Respondent chooses between a pair of adjectives and chooses an according score from one to seven. All personality dimensions are evaluated separately from specific pairs of adjectives and sum of these pairs scores. Lithuanian version is adapted from A.Bunevičius (2006).
Time Frame
Assessment score gathered once (Day 1)
Title
Galvanic skin response. Valence
Description
Galvanic skin response peaks (countable) either total or within positive, negative and neutral condition valence.
Time Frame
Assessment score gathered once (Day 1)
Title
Galvanic skin response. Amplitude
Description
Galvanic skin response is measured in microsiemens. Sudden rise in skin conductivity is called a peak. Peak amplitudes (in microsiemens) will be recorded and analysed. Average amplitude of peaks, either total or within positive, negative and neutral valence.
Time Frame
Assessment score gathered once (Day 1)
Title
Galvanic skin response. Peaks/minute
Description
Peaks/minute (normalized measure) either total or within positive, negative and neutral valence.
Time Frame
Assessment score gathered once (Day 1)
Title
Facial expression analysis. Duration of positive valence.
Description
Facial expression analysis determines the respondents' valence (negative, positive or neutral). The duration of positive valence (more than 30 percent threshold) will be assessed seconds.
Time Frame
Assessment score gathered once (Day 1)
Title
Facial expression analysis. Duration of negative valence.
Description
Facial expression analysis determines the respondents' valence (negative, positive or neutral), the duration of negative valence (less than 30 percent threshold) will be assessed in seconds.
Time Frame
Assessment score gathered once (Day 1)
Title
Facial expression analysis. Duration of neutral valence.
Description
Facial expression analysis determines the respondents' valence (negative, positive or neutral). The duration of neutral valence (from -30 percent to 30 percent threshold) will be assessed in seconds.
Time Frame
Assessment score gathered once (Day 1)
Title
Facial expression analysis. Total duration.
Description
Facial expression analysis determines the respondents' valence (negative, positive or neutral). A total duration of the record (measuring time in seconds) will be used.
Time Frame
Assessment score gathered once (Day 1)
Secondary Outcome Measure Information:
Title
Heart rate
Description
Using optical pulse sensors we aim to register beats per minute throughout the whole participation of the respondents.
Time Frame
Assessment score gathered once (Day 1)
Title
Facial expression analysis (raw data)
Description
Average of probability scores for each emotion and facial expression.
Time Frame
Assessment score gathered once (Day 1)
Title
Facial expression analysis threshold
Description
Fraction of time that an emotion or facial expression crosses the threshold of 30 percent.
Time Frame
Assessment score gathered once (Day 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Lithuanian University of Health Sciences Kaunas Clinics
City
Kaunas
Country
Lithuania

12. IPD Sharing Statement

Learn more about this trial

Atypical Orofacial Pain Diagnostics and Differentiation.

We'll reach out to this number within 24 hrs