Somatosensory Investigation of Orofacial Pain Patients

NCT02910336 | Completed

• 1 other identifier: MYTP-01
• Study Type: observational
• Target: 336
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Facial Pain; Comorbidity; Neuralgia

Outcome Measures

Primary Outcomes (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.

  base line: 2 hours examination

Study Arms (2)

Cases

Orofacial Pain patients under went to quantitative sensory test

Other: Quantitative Sensory Testing

Control

Volunteers and presented neither previous diagnostic of orofacial pain nor generalized pain, under went to quantitative sensory test

Other: Quantitative Sensory Testing

Interventions

Quantitative Sensory Testing OTHER

sensory testing profile

Cases; Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Cases are participants with orofacial pain for more than six months prior to the evaluation

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

MeSH Terms

Conditions

Facial Pain; Neuralgia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Silvia Siqueira, DDS, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: September 22, 2016
• Study Start: December 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 7, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share