Facial PainQSTNCT02910336
Somatosensory Investigation of Orofacial Pain Patients
An observational study of Facial Pain and Comorbidity, run by University of Sao Paulo.
Trial summary
Orofacial pain, specially neuropathic orofacial pain, is a challenge of diagnosis and treatment in orofacial pain. It is associated with sensory abnormalities.With increasing life expectancy of the population is more and more common to find individuals with chronic diseases however, there is little evidence about the… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Facial Pain, Comorbidity, Neuralgia
- What is being tested?
- Quantitative Sensory Testing
- How many people
- 336 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Dec 2012
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The orofacial pain conditions include neuropathic pain, Temporomandibular Disorders (TMD), headache and fibromyalgia were diagnosed according to IASP (International Association for the Study of Pain) criteria. TMD were diagnosed following the American Academy of Orofacial Pain (AAOP). All orofacial pain were diagnoses by a trained orofacial pain specialist. Finally, patients with headache were diagnosed by a neurologist using the International Headache Classification (ICHD) criteria. Diabetes mellitus and diabetic neuropathy were diagnosed by an endocrinologist from our Hospital according to the World Health Organization (WHO) recommendations and fibromyalgia were diagnosed by a physiatrist using the American Academy of Rheumatology criteria. All controls were healthy and presented neither previous diagnostic of orofacial pain nor generalized pain.
Who may be able to join
- Cases are participants with orofacial pain for more than six months prior to the evaluation
Who cannot join
- Case and controls were excluded if they had any history of trauma on face and/or skull surgery (except post traumatic neuropathic pain), generalized pain (except fibromyalgia), systemic diseases that cause neuropathy, neurodegenerative diseases, neuroendocrine diseases (except Diabetes Mellitus), rheumatologic diseases, and neuroinfectious diseases
About this study
Orofacial pain, specially neuropathic orofacial pain, is a challenge of diagnosis and treatment in orofacial pain. It is associated with sensory abnormalities.With increasing life expectancy of the population is more and more common to find individuals with chronic diseases however, there is little evidence about the influence of comorbidities and medications in use on sensory thresholds of neuropathic orofacial pain. Objective: to investigate the influence of comorbidities and medication in somatosensory function of patients with orofacial neuropathic pain compared to controls.In this case-control study, 336 orofacial pain patients and controls were recruited from the Hospital das Clinicas da Faculdade de Medicina da USP were investigated about comorbidities, use of chronic medication, pain characteristics and a detailed standardized protocol of somatosensory evaluation at the trigeminal territories for cold, warm, tactile, vibration, deep, superficial and electric pain thresholds.
Read the detailed description
Comorbidities The patients were interviewed by the same orofacial pain specialist using a questioner at the moment of the quantitative sensitive test.
Orofacial evaluation Instruments for orofacial evaluation. The questionnaires and exams were performed by one researcher only, a dentist, who ensured the clear understanding of the content by the participants before starting the protocol. All subjects underwent a standardized protocol for the evaluation of the orofacial region, including main complaint, pain characteristics [location, quality, duration, descriptors, intensity by the Visual Analog Scale (VAS), alleviation and aggravation factors], earache, headache, generalized body pain, sleep disturbances. Masticatory complaints related to parafunctional habits, laterality and the quality of mastication were also investigated. The intensity of masticatory discomfort was evaluated with the VAS. The intraoral examination included the evaluation of teeth, periodontal tissues, oral mucosa, tongue, lips, and facial skin, prostheses, occlusion and functional aspects, such as mandibular movements (mouth opening, protrusion, laterality) and temporomandibular joint (TMJ) exam (noises, spontaneous pain, or pain concomitant with movements). The muscular palpation of the head and neck was performed at the bilateral masseter, temporalis, digastrics, sternocleidomastoid, trapezius, splenius and suboccipitals. The periodontal exam was performed with adequate probes and the diagnoses made in accordance to the criteria of the American Academy of Periodontology. All participants underwent this detailed investigation for differential diagnosis with dental pain etiologies. Previous studies have shown that they can be associated with the main diagnosis of the patients.
Sensory investigation All subjects were interviewed about their perception of sensorial abnormalities such as numbness, dysesthesia, taste and smell complaints. The frequency of these abnormalities (absent, eventual, frequent, or constant) and the intensity (0-10 by VAS) were analyzed. This protocol is important for neuropathic and non-neuropathic pain diseases because somatic pain also presents sensitization and chronification.
QST. All subjects underwent a standardized protocol of QST which consists of 8 tests grouped as follows:
- gustative and olfactory thresholds;
- thermal detection thresholds for cold and warm sensations;
- mechanical detection thresholds for touch and vibration;
- mechanical pain sensitivity including superficial and deep pain thresholds. The somatosensory testing was performed at the 3 trigeminal branches (ophthalmic: fronte2 cm above the pupil, maxillary: cheek e 1 cm lateral to the nose wing, and mandibular: chin skin e 1 cm below the lip angle), at the hand dorsum (1 cm lateral to the thumb basis) and the anterior tibia skin (10 cm below the basis of patella). The evaluation was performed bilaterally in all subjects. All subjects were evaluated in the sitting position, with the head resting at a flat surface, and in a silent room with acoustic protection and the door closed. Only the participant and the researcher were in the room. All subjects were evaluated by the same researcher. The participants were oriented to keep the eyes closed during the exam, to be focused on the stimuli, and to their location (face and mouth) and characteristics. Only the researcher knew the order of the stimuli. Gustative thresholds: the following four substances, corresponding to the 4 tastes, were tested. For each test, one drop was applied at the tongue, starting with the low concentration, interleaved with one drop of distillate water, and the concentrations were tested until the subject had detected and identified the stimulus.
Sweet: glucose (0.01 M; 0.032 M; 0.1 M; 0.32 M; 1.0 M); Salty: sodium chloride (0.01 M; 0.032 M; 0.1 M; 0.32 M;1.0 M); Sour: citric acid (0.00032 M; 0.001 M; 0.0032 M;0.01 M; 0.032 M); Bitter: urea (0.1 M; 0.32 M; 1.0 M;3.2 M; 10.0 M). Olfactory thresholds: the subjects were evaluated with isopropanol solutions in polyethylene bottles interleaved with distillate water, starting with the lowconcentration until the subject had detected the stimulus;0.09%, 13.0%, 23.0%, 35.0%, 53.0%, 70.0%.
Thermal detection: thermal testing was performed using the MSA thermo test device (Somedic, Sweden). The baseline temperature was 32°C and the contact square area of the thermode was 9 x 9 mm. Cold detection threshold and warm detection threshold were assessed using ramped stimuli 1°C/s. The evaluation consisted in 5 measurements for each thermal threshold, and the means and standard deviations were considered for the analysis.
Mechanical detection threshold: touch perception was assessed using a set of standardized von Frey filaments with rounded tips of 0.5 mm diameter, applied with an electronic device (IITC, Woodland Hills, CA, USA). Three measurements in g/mm2 were performed and the means and SDs were considered for the analysis.
Vibration detection threshold: vibration testing was was performed using the electronic Vibrameter device(Somedic, Sweden) with a vibrator of 650 g of weight and a contact area of 1 cm2 perpendicularly applied for the thresholds detection, using ramped stimuli of 1 Hz/s. The method of calculation of vibration threshold consisted in the mean between the appearance and disappearance thresholds detected by the patient.
Pressure pain perception: deep pain thresholds were measured with the electronic pressure algometer (Somedic, Sweden) with a probe area of 1 cm2 which was pressed on the skin with a ramp rate of 50 kPa/s. Superficial pain perception: superficial pain thresholds were determined using disposable needles of 8x10x0.5 mm, applied with an electronic device (IITC, Woodland Hills, CA, USA). Three measurements in g/mm2 were performed and the means and SDs were considered for the analysis.
- Conditions
- Facial Pain, Comorbidity, Neuralgia
- Being tested
- Quantitative Sensory Testing
- Medical subject headings
- Facial Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Sensory TestingOther
sensory testing profile
| Study group | Role | What they receive |
|---|---|---|
| Cases | Orofacial Pain patients under went to quantitative sensory test Receives: Other: Quantitative Sensory Testing | |
| Control | Volunteers and presented neither previous diagnostic of orofacial pain nor generalized pain, under went to quantitative sensory test Receives: Other: Quantitative Sensory Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory abnormalities measure through quantitative sensory testing
Quantitative sensory testing was used to measure alteration in sensory profiles. We used to measure differences in a cohort of patients with neuropathic orofacial pain, different stimuli, such as: cold and warm detection threshold, cold and heat pain threshold, mechanical detection threshold, pain mechanical threshold and vibration detection.
Measured: base line: 2 hours examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startDec 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial PainStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 336 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Galhardoni, University of Sao Paulo
- Investigators
- Silvia Siqueira, DDS, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910336
- Sponsor's protocol ID
- MYTP-01
- Acronym
- QST
- Status last verified
- Nov 2017
- First submitted
- 31 Mar 2016
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatosensory Investigation of Orofacial Pain Patients
- ClinicalTrials.gov ID
- NCT02910336
- Acronym / sponsor ID
- QST / MYTP-01
- Conditions
- Facial Pain, Comorbidity, Neuralgia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Sep 2016 (estimated)
- 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, specially neuropathic orofacial pain, is a challenge of diagnosis and treatment in orofacial pain. It is associated with sensory abnormalities.With increasing life expectancy of the population is more and more common to find individuals with chronic diseases however, there is little evidence about the influence of comorbidities and medications in use on sensory thresholds of neuropathic orofacial pain. Objective: to investigate the influence of comorbidities and medication in somatosensory function of patients with orofacial neuropathic pain compared to controls.In this case-control study, 336 orofacial pain patients and controls were recruited from the Hospital das Clinicas da Faculdade de Medicina da USP were investigated about comorbidities, use of chronic medication, pain characteristics and a detailed standardized protocol of somatosensory evaluation at the trigeminal territories for cold, warm, tactile, vibration, deep, superficial and electric pain thresholds.
Detailed description
Comorbidities The patients were interviewed by the same orofacial pain specialist using a questioner at the moment of the quantitative sensitive test.
Orofacial evaluation Instruments for orofacial evaluation. The questionnaires and exams were performed by one researcher only, a dentist, who ensured the clear understanding of the content by the participants before starting the protocol. All subjects underwent a standardized protocol for the evaluation of the orofacial region, including main complaint, pain characteristics [location, quality, duration, descriptors, intensity by the Visual Analog Scale (VAS), alleviation and aggravation factors], earache, headache, generalized body pain, sleep disturbances. Masticatory complaints related to parafunctional habits, laterality and the quality of mastication were also investigated. The intensity of masticatory discomfort was evaluated with the VAS. The intraoral examination included the evaluation of teeth, periodontal tissues, oral mucosa, tongue, lips, and facial skin, prostheses, occlusion and functional aspects, such as mandibular movements (mouth opening, protrusion, laterality) and temporomandibular joint (TMJ) exam (noises, spontaneous pain, or pain concomitant with movements). The muscular palpation of the head and neck was performed at the bilateral masseter, temporalis, digastrics, sternocleidomastoid, trapezius, splenius and suboccipitals. The periodontal exam was performed with adequate probes and the diagnoses made in accordance to the criteria of the American Academy of Periodontology. All participants underwent this detailed investigation for differential diagnosis with dental pain etiologies. Previous studies have shown that they can be associated with the main diagnosis of the patients.
Sensory investigation All subjects were interviewed about their perception of sensorial abnormalities such as numbness, dysesthesia, taste and smell complaints. The frequency of these abnormalities (absent, eventual, frequent, or constant) and the intensity (0-10 by VAS) were analyzed. This protocol is important for neuropathic and non-neuropathic pain diseases because somatic pain also presents sensitization and chronification.
QST. All subjects underwent a standardized protocol of QST which consists of 8 tests grouped as follows:
- gustative and olfactory thresholds;
- thermal detection thresholds for cold and warm sensations;
- mechanical detection thresholds for touch and vibration;
- mechanical pain sensitivity including superficial and deep pain thresholds. The somatosensory testing was performed at the 3 trigeminal branches (ophthalmic: fronte2 cm above the pupil, maxillary: cheek e 1 cm lateral to the nose wing, and mandibular: chin skin e 1 cm below the lip angle), at the hand dorsum (1 cm lateral to the thumb basis) and the anterior tibia skin (10 cm below the basis of patella). The evaluation was performed bilaterally in all subjects. All subjects were evaluated in the sitting position, with the head resting at a flat surface, and in a silent room with acoustic protection and the door closed. Only the participant and the researcher were in the room. All subjects were evaluated by the same researcher. The participants were oriented to keep the eyes closed during the exam, to be focused on the stimuli, and to their location (face and mouth) and characteristics. Only the researcher knew the order of the stimuli. Gustative thresholds: the following four substances, corresponding to the 4 tastes, were tested. For each test, one drop was applied at the tongue, starting with the low concentration, interleaved with one drop of distillate water, and the concentrations were tested until the subject had detected and identified the stimulus.
Sweet: glucose (0.01 M; 0.032 M; 0.1 M; 0.32 M; 1.0 M); Salty: sodium chloride (0.01 M; 0.032 M; 0.1 M; 0.32 M;1.0 M); Sour: citric acid (0.00032 M; 0.001 M; 0.0032 M;0.01 M; 0.032 M); Bitter: urea (0.1 M; 0.32 M; 1.0 M;3.2 M; 10.0 M). Olfactory thresholds: the subjects were evaluated with isopropanol solutions in polyethylene bottles interleaved with distillate water, starting with the lowconcentration until the subject had detected the stimulus;0.09%, 13.0%, 23.0%, 35.0%, 53.0%, 70.0%.
Thermal detection: thermal testing was performed using the MSA thermo test device (Somedic, Sweden). The baseline temperature was 32°C and the contact square area of the thermode was 9 x 9 mm. Cold detection threshold and warm detection threshold were assessed using ramped stimuli 1°C/s. The evaluation consisted in 5 measurements for each thermal threshold, and the means and standard deviations were considered for the analysis.
Mechanical detection threshold: touch perception was assessed using a set of standardized von Frey filaments with rounded tips of 0.5 mm diameter, applied with an electronic device (IITC, Woodland Hills, CA, USA). Three measurements in g/mm2 were performed and the means and SDs were considered for the analysis.
Vibration detection threshold: vibration testing was was performed using the electronic Vibrameter device(Somedic, Sweden) with a vibrator of 650 g of weight and a contact area of 1 cm2 perpendicularly applied for the thresholds detection, using ramped stimuli of 1 Hz/s. The method of calculation of vibration threshold consisted in the mean between the appearance and disappearance thresholds detected by the patient.
Pressure pain perception: deep pain thresholds were measured with the electronic pressure algometer (Somedic, Sweden) with a probe area of 1 cm2 which was pressed on the skin with a ramp rate of 50 kPa/s. Superficial pain perception: superficial pain thresholds were determined using disposable needles of 8x10x0.5 mm, applied with an electronic device (IITC, Woodland Hills, CA, USA). Three measurements in g/mm2 were performed and the means and SDs were considered for the analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Quantitative Sensory TestingOrofacial Pain patients under went to quantitative sensory test |
| Control | – | Other: Quantitative Sensory TestingVolunteers and presented neither previous diagnostic of orofacial pain nor generalized pain, under went to quantitative sensory test |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The orofacial pain conditions include neuropathic pain, Temporomandibular Disorders (TMD), headache and fibromyalgia were diagnosed according to IASP (International Association for the Study of Pain) criteria. TMD were diagnosed following the American Academy of Orofacial Pain (AAOP). All orofacial pain were diagnoses by a trained orofacial pain specialist. Finally, patients with headache were diagnosed by a neurologist using the International Headache Classification (ICHD) criteria. Diabetes mellitus and diabetic neuropathy were diagnosed by an endocrinologist from our Hospital according to the World Health Organization (WHO) recommendations and fibromyalgia were diagnosed by a physiatrist using the American Academy of Rheumatology criteria. All controls were healthy and presented neither previous diagnostic of orofacial pain nor generalized pain.
Key inclusion criteria (1 listed)
- Cases are participants with orofacial pain for more than six months prior to the evaluation
Key exclusion criteria (1 listed)
- Case and controls were excluded if they had any history of trauma on face and/or skull surgery (except post traumatic neuropathic pain), generalized pain (except fibromyalgia), systemic diseases that cause neuropathy, neurodegenerative diseases, neuroendocrine diseases (except Diabetes Mellitus), rheumatologic diseases, and neuroinfectious diseases
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 |
|---|---|---|
| Quantitative Sensory Testingsensory testing profile | Other | Cases, Control |
Primary outcome
Sensory abnormalities measure through quantitative sensory testing
Time frame: base line: 2 hours examination
Quantitative sensory testing was used to measure alteration in sensory profiles. We used to measure differences in a cohort of patients with neuropathic orofacial pain, different stimuli, such as: cold and warm detection threshold, cold and heat pain threshold, mechanical detection threshold, pain mechanical threshold and vibration detection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Individual participant dataSharing planned: No
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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.
Silvia Siqueira, DDS, PhD principal investigator
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
An observational study of Facial Pain and Comorbidity, run by University of Sao Paulo.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensory abnormalities measure through quantitative sensory testing (time frame: base line: 2 hours examination). 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 7 Nov 2017.