Persistent Idiopathic Facial PainNCT04775758
Atypical Orofacial Pain Diagnostics and Differentiation.
A study testing Self-evaluating questionnaires and iMotions analysis platform in people with Persistent Idiopathic Facial Pain, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Persistent Idiopathic Facial Pain
- What is being tested?
- Self-evaluating questionnaires and iMotions analysis platform
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteLithuania
- Study dates
- 27 Feb 2021to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
Lithuanian University of Health Sciences Kaunas Clinics
Kaunas
About this study
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
- Being tested
- Self-evaluating questionnaires, iMotions analysis platform
- Keywords
- Persistent Idiopathic Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-evaluating questionnairesBehavioural
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 platformBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Atypical facial pain group | Experimental | 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. Receives: Behavioral: Self-evaluating questionnaires; Behavioral: iMotions analysis platform |
| Maxillofacial fracture pain group | Active comparator | 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. Receives: Behavioral: Self-evaluating questionnaires; Behavioral: iMotions analysis platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessment score gathered once (Day 1)
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.
Measured: Assessment score gathered once (Day 1)
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).
Measured: Assessment score gathered once (Day 1)
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).
Measured: Assessment score gathered once (Day 1)
Galvanic skin response. Valence
Galvanic skin response peaks (countable) either total or within positive, negative and neutral condition valence.
Measured: Assessment score gathered once (Day 1)
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.
Measured: Assessment score gathered once (Day 1)
Galvanic skin response. Peaks/minute
Peaks/minute (normalized measure) either total or within positive, negative and neutral valence.
Measured: Assessment score gathered once (Day 1)
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.
Measured: Assessment score gathered once (Day 1)
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.
Measured: Assessment score gathered once (Day 1)
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.
Measured: Assessment score gathered once (Day 1)
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.
Measured: Assessment score gathered once (Day 1)
Secondary outcomes (3)
Heart rate
Using optical pulse sensors we aim to register beats per minute throughout the whole participation of the respondents.
Measured: Assessment score gathered once (Day 1)
Facial expression analysis (raw data)
Average of probability scores for each emotion and facial expression.
Measured: Assessment score gathered once (Day 1)
Facial expression analysis threshold
Fraction of time that an emotion or facial expression crosses the threshold of 30 percent.
Measured: Assessment score gathered once (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start27 Feb 2021 (estimated)
- Primary completion22 Jul 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Idiopathic Facial PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Pavel Rokicki, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775758
- Sponsor's protocol ID
- 1-VZCH
- Status last verified
- Feb 2021
- First submitted
- 21 Feb 2021
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atypical Orofacial Pain Diagnostics and Differentiation.
- ClinicalTrials.gov ID
- NCT04775758
- Acronym / sponsor ID
- 1-VZCH
- Conditions
- Persistent Idiopathic Facial Pain
- Keywords
- Persistent Idiopathic Facial Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 27 Feb 2021 (estimated)
- Primary completion
- 22 Jul 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atypical facial pain group | Experimental | Behavioral: Self-evaluating questionnaires, Behavioral: iMotions analysis platformPatients 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. |
| Maxillofacial fracture pain group | Active comparator | Behavioral: Self-evaluating questionnaires, Behavioral: iMotions analysis platformPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-evaluating questionnairesPatients 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. | Behavioural | Atypical facial pain group, Maxillofacial fracture pain group |
| iMotions analysis platformWhile 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. | Behavioural | Atypical facial pain group, Maxillofacial fracture pain group |
Primary outcome
Visual analog scale
Time frame: Assessment score gathered once (Day 1)
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
Time frame: Assessment score gathered once (Day 1)
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
Time frame: Assessment score gathered once (Day 1)
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
Time frame: Assessment score gathered once (Day 1)
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
Time frame: Assessment score gathered once (Day 1)
Galvanic skin response peaks (countable) either total or within positive, negative and neutral condition valence.
Galvanic skin response. Amplitude
Time frame: Assessment score gathered once (Day 1)
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
Time frame: Assessment score gathered once (Day 1)
Peaks/minute (normalized measure) either total or within positive, negative and neutral valence.
Facial expression analysis. Duration of positive valence.
Time frame: Assessment score gathered once (Day 1)
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.
Time frame: Assessment score gathered once (Day 1)
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.
Time frame: Assessment score gathered once (Day 1)
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.
Time frame: Assessment score gathered once (Day 1)
Facial expression analysis determines the respondents' valence (negative, positive or neutral). A total duration of the record (measuring time in seconds) will be used.
3 secondary outcomes
Heart rate
Time frame: Assessment score gathered once (Day 1)
Facial expression analysis (raw data)
Time frame: Assessment score gathered once (Day 1)
Facial expression analysis threshold
Time frame: Assessment score gathered once (Day 1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-evaluating questionnaires and iMotions analysis platform in people with Persistent Idiopathic Facial Pain, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (time frame: Assessment score gathered once (Day 1)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.