Assessment and Treatment Patients With Atypical Facial Pain Trough Repetitive Transcranial Magnetic Stimulation

Not Applicable

Completed

• Conditions: Atypical Facial Pain or Atypical Odontalgia
• Interventions: Procedure: rTMS

• Registration Number: NCT01746355
• Lead Sponsor: University of Sao Paulo

Brief Summary

Atypical Facial Pain is a chronic condition and presents controversies during diagnostic and treatment, between specialist not have consensus about the pathophysiology. It is possible consider this entitie a potential neuropathic cause without pathological signs. It knows the repetitive transcranial magnetic presents good results in the treatment of chronic pain coditions. The aim this study is evaluated the thresholds and excitability cortical in patients with AFP and verify the patterns of improvement in pain for patients undergoing rTMS compared to controls, as well as the therapeutic response to neuromodulation procedures. This enroll 20 patients with DAF and 20 controls treated with rTMS (5 sessions) and evaluated through questionnaires (EDOF clinical record, McGill Pain Questionnaire, Visual Analogue Scale, Inventory of symptoms of neuropathic pain, neuropathic pain DN4 questionnaire, SF -36, brief pain inventory). At the end of the data will be statistically analyzed and expressed as mean and standard deviation, and analyzed by Student's t test, analysis of variance (ANOVA), Tukey-Kramer and Pearson correlation. The level of significance is 5%. The results will be published in journals indexed in the area both nationally and internationally and presented at conferences and scientific meetings.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2012-11-27
• Primary Completion: 2012-12
• Study First Submitted QC: 2012-12-07
• Study First Posted: 2012-12-10
• Study Completion: 2014-01
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-24
• Last Update Posted: 2014-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Fulfill criteria of Atypical Facial Pain by International Headache Society
• Signed Term of Informed Consent

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Exclusion Criteria

• Trauma of Skull, epilepsy don't treated,
• Use of medications decrease the seizure threshold
• Patients in use of drugs, how cocaine and alcohol
• neurosurgical clips, pacemakers, increased intracranial pressure (risk of sequelae after seizure)
• Pregnant or lacting women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rTMS-Sham	rTMS	patients undergoing to placebo rTMS
rTMS-active	rTMS	patients undergoing of rTMS real

Primary Outcome Measures

Name	Time	Method
Change in Baselin of Pain	base line (moment of inclusion) and end of each session rTMS (4X in three months)	Assessing by verbal analog scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Excitability cortical	baseline (in the moment of inclusion) and end of each session of rTMS (4X in three months)	Changes in the measure of excitability cortical

Trial Locations

Locations (1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP); 🇧🇷 São Paulo, SP, Brazil