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Facial PainQSTNCT02910336

Somatosensory Investigation of Orofacial Pain Patients

An observational study of Facial Pain and Comorbidity, run by University of Sao Paulo.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

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 groups in NCT02910336
Study groupRoleWhat they receive
CasesOrofacial Pain patients under went to quantitative sensory test
Receives: Other: Quantitative Sensory Testing
ControlVolunteers 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.

  1. 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.

  1. First posted22 Sep 2016 (estimated)
  2. Study startDec 2010
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

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
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

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.

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