Back to resultsAssessment and Treatment Patients With Atypical Facial Pain Trough Repetitive Transcranial Magnetic Stimulation (EMTr-AFP)
Primary Purpose
Atypical Facial Pain or Atypical Odontalgia
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
rTMS
Sponsored by
About this trial
This is an interventional diagnostic trial for Atypical Facial Pain or Atypical Odontalgia focused on measuring atypical facial pain, atypical odontalgia, repetitive transcranial magnetic stimulation, neuropathic pain, chronic pain, assessment
Eligibility Criteria
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
Sites / Locations
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
rTMS-active
rTMS-Sham
Arm Description
patients undergoing of rTMS real
patients undergoing to placebo rTMS
Outcomes
Primary Outcome Measures
Change in Baselin of Pain
Assessing by verbal analog scale (VAS)
Secondary Outcome Measures
Excitability cortical
Changes in the measure of excitability cortical
Full Information
NCT ID
NCT01746355
First Posted
November 27, 2012
Last Updated
April 24, 2014
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01746355
Brief Title
Assessment and Treatment Patients With Atypical Facial Pain Trough Repetitive Transcranial Magnetic Stimulation
Acronym
EMTr-AFP
Official Title
Assessment and Treatment Patients With Atypical Facial Pain Trough Repetitive Transcranial Magnetic Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atypical Facial Pain or Atypical Odontalgia
Keywords
atypical facial pain, atypical odontalgia, repetitive transcranial magnetic stimulation, neuropathic pain, chronic pain, assessment
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rTMS-active
Arm Type
Active Comparator
Arm Description
patients undergoing of rTMS real
Arm Title
rTMS-Sham
Arm Type
Sham Comparator
Arm Description
patients undergoing to placebo rTMS
Intervention Type
Procedure
Intervention Name(s)
rTMS
Intervention Description
Patients undergoing of repetitive transcranial magnetic stimulation for treatment of AFP.
Primary Outcome Measure Information:
Title
Change in Baselin of Pain
Description
Assessing by verbal analog scale (VAS)
Time Frame
base line (moment of inclusion) and end of each session rTMS (4X in three months)
Secondary Outcome Measure Information:
Title
Excitability cortical
Description
Changes in the measure of excitability cortical
Time Frame
baseline (in the moment of inclusion) and end of each session of rTMS (4X in three months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP)
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403900
Country
Brazil
12. IPD Sharing Statement
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Assessment and Treatment Patients With Atypical Facial Pain Trough Repetitive Transcranial Magnetic Stimulation
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