Assessment and Treatment Patients With Atypical Facial Pain Trough Repetitive Transcranial Magnetic Stimulation (EMTr-AFP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ricardo Galhardoni, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01746355
First received: November 27, 2012
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Atypical Facial Pain or Atypical Odontalgia
Procedure: rTMS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Assessment and Treatment Patients With Atypical Facial Pain Trough Repetitive Transcranial Magnetic Stimulation

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Change in Baselin of Pain [ Time Frame: base line (moment of inclusion) and end of each session rTMS (4X in three months) ] [ Designated as safety issue: No ]
    Assessing by verbal analog scale (VAS)


Secondary Outcome Measures:
  • Excitability cortical [ Time Frame: baseline (in the moment of inclusion) and end of each session of rTMS (4X in three months) ] [ Designated as safety issue: No ]
    Changes in the measure of excitability cortical


Estimated Enrollment: 40
Study Start Date: March 2011
Study Completion Date: January 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: rTMS-active
patients undergoing of rTMS real
Procedure: rTMS
Patients undergoing of repetitive transcranial magnetic stimulation for treatment of AFP.
Sham Comparator: rTMS-Sham
patients undergoing to placebo rTMS
Procedure: rTMS
Patients undergoing of repetitive transcranial magnetic stimulation for treatment of AFP.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01746355

Locations
Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP)
São Paulo, SP, Brazil, 05403900
Sponsors and Collaborators
University of Sao Paulo
  More Information

No publications provided

Responsible Party: Ricardo Galhardoni, PhD student, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01746355     History of Changes
Other Study ID Numbers: RG-01
Study First Received: November 27, 2012
Last Updated: April 24, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
atypical facial pain
atypical odontalgia
repetitive transcranial magnetic stimulation
neuropathic pain
chronic pain
assessment

Additional relevant MeSH terms:
Facies
Facial Pain
Toothache
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on August 18, 2014