Immune-Pineal Axis Function in Chronic Tension-Type Headache
NCT ID: NCT01954277
Last Updated: 2013-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
34 participants
INTERVENTIONAL
2010-10-31
2013-11-30
Brief Summary
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Detailed Description
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This is a clinical Trial study, randomised, in parallel, cross-over with a blinded assessor, and with a sham placebo control.
The study will be carried out in the Clinical Research Outpatient Clinic of the Hospital de Clínicas de Porto Alegre (HCPA), with women aged between 18 and 60 years old. The participants will respond to questionnaires at the beginning and end of each therapeutic intervention, with 24-hour urine, blood and saliva collection. The therapeutic intervention will include: 10 electroacupuncture sessions and 10 sham placebo sessions. The measurements taken will be: quality of life, depression, impact of headache on daily life, sleep quality, chronotropic types, immuno-inflammatory mediators, levels of 6-sulfatoxymelatonin, and salivary cortisol.
Through these interventions it is hoped that patients will present an improvement in their pain presentation, quality of life and sleep, as well as central autonomic regulation. Evidence for these hypotheses will support a minimally-invasive treatment, with few side-effects and a low cost.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Electroacupuncture
All patients will receive 10 electroacupuncture sessions.
Electroacupuncture
Eletroacupuncture performed using acupuncture needles.
Placebo Sham
All patients will receive 10 placebo sham sessions.
Placebo Sham
Placebo Sham is performed using electrodes, without electrical stimulation. Lights and sounds were identical to active treatment.
Interventions
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Electroacupuncture
Eletroacupuncture performed using acupuncture needles.
Placebo Sham
Placebo Sham is performed using electrodes, without electrical stimulation. Lights and sounds were identical to active treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged between 18 and 60 years old,
* Providing informed consent to participate in the study,
* Literate,
* Clinical diagnosis of Chronic Tension-Type Headache according to the International Headache Society.
Exclusion Criteria
* De-compensated systemic disease,
* Chronic inflammatory disease (e.g. Systemic Lupus Erythematous, Rheumatoid Arthritis),
* HIV.
18 Years
60 Years
FEMALE
No
Sponsors
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Federal University of Rio Grande do Sul
OTHER
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
OTHER_GOV
Hospital de Clinicas de Porto Alegre
OTHER
Responsible Party
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Wolnei Caumo
MD, PhD, Professor and coordinator of Pain & Neuromodulation Lab
Principal Investigators
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Wolnei Caumo, MD, PhD
Role: STUDY_CHAIR
Hospital de Clinicas de Porto Alegre
Mônica Chassot
Role: PRINCIPAL_INVESTIGATOR
Federal University of Health Science of Porto Alegre
Francislea C. Sehn
Role: PRINCIPAL_INVESTIGATOR
Federal University of Health Science of Porto Alegre
Rafael Vercelino
Role: PRINCIPAL_INVESTIGATOR
Federal University of Health Science of Porto Alegre
Locations
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Hospital de Clinicas e Porto Alegre (HCPA)
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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Other Identifiers
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09-259
Identifier Type: -
Identifier Source: org_study_id