Botulinum Toxin Type A in Treatment of Cranial Allodynia in Patients With Headache

Sponsor

Federal University of Bahia (Other)

Overall Status

Completed

CT.gov ID

NCT01357798

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Headache Allodynia	Drug: Botulinum toxin type A Drug: 0,9% saline	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Botulinum Toxin Type A Versus 0,9% Saline in Treatment of Cranial Allodynia in Patients With Headache

Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Btx-A: Active Comparator Botulinum Toxin group Will have the syringe with Botulinum toxin type A . During the study the patients will be following in the headache's clinic where the evaluator will graduate the pathologies' evolution.	Drug: Botulinum toxin type A Botulinum Toxin group Will have the syringe with Botulinum toxin type A . During the study the patients will be following in the headache's clinic where the evaluator will graduate the pathologies' evolution.
Placebo Comparator: Placebo Comparator 0,9% saline group Will have the syringe with 0,9% saline. During the study the patients will be following in the headache's clinic where the evaluator will graduate the pathologies' evolution .	Drug: 0,9% saline 0,9% saline group Will have the syringe with 0,9% saline. During the study the patients will be following in the headache's clinic where the evaluator will graduate the pathologies' evolution .

Arm

Intervention/Treatment

Active Comparator: Btx-A: Active Comparator

Botulinum Toxin group Will have the syringe with Botulinum toxin type A . During the study the patients will be following in the headache's clinic where the evaluator will graduate the pathologies' evolution.

Drug: Botulinum toxin type A

Placebo Comparator: Placebo Comparator

0,9% saline group Will have the syringe with 0,9% saline. During the study the patients will be following in the headache's clinic where the evaluator will graduate the pathologies' evolution .

Drug: 0,9% saline

0,9% saline group Will have the syringe with 0,9% saline. During the study the patients will be following in the headache's clinic where the evaluator will graduate the pathologies' evolution .

Outcome Measures

Primary Outcome Measures

Evaluate the allodynea's improvement following these criteria [six months]
Evaluate the allodynea's improvement following these criteria: Disappearing at least 50% infiltrated painful points.

Secondary Outcome Measures

Evaluate the headache's improvement following these criteria: [six months]
Headache's episodes reduction at least 50% in the last month or pain intensity reduction by Visual Analogue Scale (VAS) in at least three points or dose's painkiller reduction at least 50%.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients diagnosed with tensional headache or migraine as The International Classification of Headache Disorders, 2nd Edition - ICHD II
Patients from both sexes older than 18 years

Exclusion Criteria:

Fill the diagnostics criteria for more than one type of primary headache as ICHD II
Another neurological disease or systemic illness that causes headache.
Condition that contraindicate the use of Study's Medication.
Cognitive impairment
Use of botulinum toxin within the last six months
Blood, liver, or kidney disorders and pregnant or lactating women