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

This study has been completed.
Sponsor:
Information provided by:
Federal University of Bahia
ClinicalTrials.gov Identifier:
NCT01357798
First received: May 19, 2011
Last updated: May 20, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Headache
Allodynia
Drug: Botulinum toxin type A
Drug: 0,9% saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Federal University of Bahia:

Primary Outcome Measures:
  • Evaluate the allodynea's improvement following these criteria [ Time Frame: six months ] [ Designated as safety issue: No ]
    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: [ Time Frame: six months ] [ Designated as safety issue: No ]
    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%.


Estimated Enrollment: 40
Study Start Date: December 2010
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 .

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357798

Locations
Brazil
Hospital Universitário Alcides Carneiro
Campina Grande, Paraíba, Brazil, 58100000
Sponsors and Collaborators
Federal University of Bahia
  More Information

No publications provided

Responsible Party: PHD Ailton de Souza Melo, UFBA
ClinicalTrials.gov Identifier: NCT01357798     History of Changes
Other Study ID Numbers: LHUFBA001
Study First Received: May 19, 2011
Last Updated: May 20, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of Bahia:
Headache
Allodynia
Botulinum Toxin Type A

Additional relevant MeSH terms:
Headache
Hyperalgesia
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Somatosensory Disorders
Sensation Disorders
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 20, 2014