Botulinum Toxin Type A in Treatment of Cranial Allodynia in Patients With Headache
Primary Purpose
Headache, Allodynia
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Botulinum toxin type A
0,9% saline
Sponsored by
About this trial
This is an interventional treatment trial for Headache focused on measuring Headache, Allodynia, Botulinum Toxin Type A
Eligibility Criteria
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
Sites / Locations
- Hospital Universitário Alcides Carneiro
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Btx-A: Active Comparator
Placebo Comparator
Arm Description
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.
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 .
Outcomes
Primary Outcome Measures
Evaluate the allodynea's improvement following these criteria
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:
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%.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01357798
Brief Title
Botulinum Toxin Type A in Treatment of Cranial Allodynia in Patients With Headache
Official Title
Botulinum Toxin Type A Versus 0,9% Saline in Treatment of Cranial Allodynia in Patients With Headache
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of Bahia
4. Oversight
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Allodynia
Keywords
Headache, Allodynia, Botulinum Toxin Type A
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Btx-A: Active Comparator
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
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 .
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type A
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
0,9% saline
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Evaluate the allodynea's improvement following these criteria
Description
Evaluate the allodynea's improvement following these criteria: Disappearing at least 50% infiltrated painful points.
Time Frame
six months
Secondary Outcome Measure Information:
Title
Evaluate the headache's improvement following these criteria:
Description
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%.
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Universitário Alcides Carneiro
City
Campina Grande
State/Province
Paraíba
ZIP/Postal Code
58100000
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Botulinum Toxin Type A in Treatment of Cranial Allodynia in Patients With Headache
We'll reach out to this number within 24 hrs