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

NCT ID: NCT01746355

Last Updated: 2014-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-01-31

Brief Summary

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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

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Conditions

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Atypical Facial Pain or Atypical Odontalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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rTMS-active

patients undergoing of rTMS real

Group Type ACTIVE_COMPARATOR

rTMS

Intervention Type PROCEDURE

Patients undergoing of repetitive transcranial magnetic stimulation for treatment of AFP.

rTMS-Sham

patients undergoing to placebo rTMS

Group Type SHAM_COMPARATOR

rTMS

Intervention Type PROCEDURE

Patients undergoing of repetitive transcranial magnetic stimulation for treatment of AFP.

Interventions

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rTMS

Patients undergoing of repetitive transcranial magnetic stimulation for treatment of AFP.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Ricardo Galhardoni

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP)

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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RG-01

Identifier Type: -

Identifier Source: org_study_id

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