Chronic Tension-Type Headache Clinical Trial
Official title:
Immune-Pineal Axis Function in Chronic Tension-Type Headache: Noradrenergic Modulation and the Effect of Electroacupuncture
The purpose of this study is to determine whether electroacupuncture is effective in the treatment of chronic tension-type headache, measured by Headache Impact Test, Visual Analogue Scale and biomarkers.
Tension-type headache can be defined as a constant sensation of pressure or heaviness, and
is a highly-prevalent condition in the health services. The objective of the present study
is to investigate the function of the immuno-pineal axis in chronic tension headache,
focussed on the neuro-immune regulatory dysfunction. In addition, the effect of
neuro-stimulation (electroacupuncture) on the function of this axis will also be studied.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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