Headache Clinical Trial
Official title:
Botulinum Toxin Type A Versus 0,9% Saline in Treatment of Cranial Allodynia in Patients With Headache
The objective of this study is evaluated if the Botulinum Toxin Type A is superior to 0,9%
saline in treatment of cranial Allodynia in patients with headache.
Hypothesis
H(0): Botulinum Toxin Type A is not superior to 0,9% saline in treatment of cranial
Allodynia in patients with headache
H (1): Botulinum Toxin Type A is superior to 0,9% saline in treatment of cranial Allodynia
in patients with headache
After adequation and approve from ethics committee on research involving human the selection
of patients with tension headache or migraine according to The International Classification
of Headache Disorders, 2nd Edition (ICHD II) will start in the Headache Clinic of Alcides
Carneiro Universitary Hospital. Those selected will be oriented regarding to the study steps
and potential risks of the procedures. The patients will catalog the occurrence of headache
and use of analgesics for 30 days through daily headache. At the end of this month patients
will be evaluated by a physician experienced in the treatment of headache to define the
occurrence of pain or allodynia of the scalp. Data gathered in this consultation will be
recorded in standardized questionnaires for the study. The questionnaire is divided:
Patient's identification, illustration of the pain area and allodynea points, pain intensity
by Visual Analogue Scale (VAS) and finally medication use will be collected in the Headache
Diary.
The people are randomized with block permutation, security of equal distribution in two
groups (number previous determined). One group with 0,9% saline and the other Botulinum
Toxin A.
Finishing the application by the Researcher (Who doesn't know the result of randomization
and the infiltrated containing). The patients will be submit to three evaluations: the
first, 30 days after infiltration, with a doctor who didn't participate of the anterior
steps and will analyze the pain intensity by Visual Analogue Scale (VAS), an episode of
headache and use of painkiller trough Headache Diary. The Doctor will ask to the patient
localize, if exist, the allodynia points. The others evolution visit will happen 60 and 90
days after application, with this same doctor using the same methods. Another professional,
who doesn't know about the anterior steps of the study, will do the statics data analyze.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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