Clinical trial NCT01954277: Immune-Pineal Axis Function in Chronic Tension-Type Headache
Official title: Immune-Pineal Axis Function in Chronic Tension-Type Headache: Noradrenergic Modulation and the Effect of Electroacupuncture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Tension-Type Headache
Keywords: Chronic Tension-Type Headache
Electroacupuncture
Headache Impact
BDNF
TNF
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2013-10-01
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Women,
* 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:

* Psychiatric or neurologic disorder that unable patient to consent and follow study protocol,
* De-compensated systemic disease,
* Chronic inflammatory disease (e.g. Systemic Lupus Erythematous, Rheumatoid Arthritis),
* HIV.

Primary outcomes:
measure: Pain Visual Analogue Scale (VAS)
timeFrame: An expected average of 3 months. (At baseline and at the end of each intervention period).
Secondary outcomes:
measure: Headache Impact Test (HIT-6)
timeFrame: An expected average of 3 months. (At baseline and at the end of each intervention period).
Other outcomes:
measure: Biomarkers (BDNF nd TNF)
timeFrame: An expected average of 3 months. (At baseline and at the end of each intervention period).
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas e Porto Alegre (HCPA)
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Wolnei Caumo, MD, PhD
role: STUDY_CHAIR
affiliation: Federal University of Health Science of Porto Alegre
name: Mônica Chassot
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Health Science of Porto Alegre
name: Francislea C. Sehn
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Health Science of Porto Alegre
name: Rafael Vercelino
role: PRINCIPAL_INVESTIGATOR
References: