Atypical Facial Pain or Atypical Odontalgia Clinical Trial
— EMTr-AFPOfficial title:
Assessment and Treatment Patients With Atypical Facial Pain Trough Repetitive Transcranial Magnetic Stimulation
| Verified date | April 2014 |
| Source | University of Sao Paulo |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Brazil: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | January 2014 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP) | São Paulo | SP |
| Lead Sponsor | Collaborator |
|---|---|
| University of Sao Paulo |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Baselin of Pain | Assessing by verbal analog scale (VAS) | base line (moment of inclusion) and end of each session rTMS (4X in three months) | No |
| Secondary | Excitability cortical | Changes in the measure of excitability cortical | baseline (in the moment of inclusion) and end of each session of rTMS (4X in three months) | No |