Clinical Trials Logo

Clinical 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 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT02910336
Study type Observational [Patient Registry]
Source University of Sao Paulo
Contact
Status Completed
Phase N/A
Start date December 2010
Completion date December 2012

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04066933 - Forms of Cervical Brachial Syndrome Treated With Plasma Concentrate Enriched for A2M
Completed NCT01202227 - An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain Phase 3
Completed NCT00922987 - Clinical Study With Lyrica In Patients Suffering From Epilepsy
Terminated NCT00964990 - A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 in Patients With Neuropathic Pain (Postherpetic Neuralgia and Post-traumatic Neuralgia) Phase 2
Recruiting NCT00740571 - Amitriptyline or Pregabalin to Treat Neuropathic Pain in Incurable Cancer Phase 3
Terminated NCT02747758 - Transcranial Direct Current Stimulation (tDCS) in Chronic Neuropathy N/A
Completed NCT05464199 - Home-based EEG Neurofeedback for Chronic Neuropathic Pain Phase 1
Completed NCT02490436 - Novel Treatment Option for Neuropathic Pain Phase 2
Completed NCT01974791 - GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain N/A
Completed NCT01279018 - Persistent Pain After Breast Cancer Treatment With Docetaxel N/A
Not yet recruiting NCT00944502 - To Evaluate the Efficacy and Tolerability of the Use of Vitatonus Dexa Compared to Dexamethasone in Patients With Neuralgia of Various Origins Phase 3
Completed NCT02957851 - EMONO for the Treatment of Peripheral Neuropathic Pain Phase 2
Completed NCT02180880 - Symptom Based Treatment of Neuropathic Pain Phase 4
Active, not recruiting NCT01508676 - Effects of Pennsaid on Clinical Neuropathic Pain N/A
Completed NCT00631943 - A Study to Evaluate the Efficacy and Safety of Pregabalin (Lyrica) for the Treatment of Nerve Pain Phase 3
Completed NCT03973983 - Comparison of Ultrasound-guided Transgluteal and Finger-guided Transvaginal Pudendal Nerve Block Techniques N/A
Terminated NCT03296111 - Patients With Ocular Neuropathic Pain: Description of Pain and Impact on Their Quality of Life
Not yet recruiting NCT06398847 - Virtual Reality (VR) Self-Hypnosis Software N/A
Terminated NCT02460107 - Botulinum Toxin Type A for Neuropathic Pain in Patients With Diabetic Peripheral Polyneuropathy Early Phase 1
Recruiting NCT01788410 - MRI-Guided Cryoablation to Alleviate Pain in Head, Neck and Spine