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

May 20, 2011 updated by: Federal University of Bahia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Paraíba
      • Campina Grande, Paraíba, Brazil, 58100000
        • Hospital Universitário Alcides Carneiro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the allodynea's improvement following these criteria
Time Frame: six months
Evaluate the allodynea's improvement following these criteria: Disappearing at least 50% infiltrated painful points.
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the headache's improvement following these criteria:
Time Frame: 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%.
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Bahia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

April 1, 2011

Study Registration Dates

First Submitted

May 19, 2011

First Submitted That Met QC Criteria

May 20, 2011

First Posted (ESTIMATE)

May 23, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 23, 2011

Last Update Submitted That Met QC Criteria

May 20, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LHUFBA001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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