Immune-Pineal Axis Function in Chronic Tension-Type Headache
Immune-Pineal Axis Function in Chronic Tension-Type Headache: Noradrenergic Modulation and the Effect of Electroacupuncture
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
- Fase 3
Contacten en locaties
Studie Locaties
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazilië, 90035-003
- Hospital de Clinicas e Porto Alegre (HCPA)
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Electroacupuncture
All patients will receive 10 electroacupuncture sessions.
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Eletroacupuncture performed using acupuncture needles.
Andere namen:
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Sham-vergelijker: Placebo Sham
All patients will receive 10 placebo sham sessions.
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Placebo Sham is performed using electrodes, without electrical stimulation.
Lights and sounds were identical to active treatment.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Pain Visual Analogue Scale (VAS)
Tijdsspanne: An expected average of 3 months. (At baseline and at the end of each intervention period).
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The intensity of pain was measured by a 10 cm VAS.
The scores range from no pain (zero) to the worst possible pain (10 cm).
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An expected average of 3 months. (At baseline and at the end of each intervention period).
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Headache Impact Test (HIT-6)
Tijdsspanne: An expected average of 3 months. (At baseline and at the end of each intervention period).
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This test was developed in 2004, and has equivalent psychometric properties in nine languages, including Portuguese.
It consists of six questions that assess the impact of headache on the ability to work, study, home and in social situations.
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An expected average of 3 months. (At baseline and at the end of each intervention period).
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Biomarkers (BDNF nd TNF)
Tijdsspanne: An expected average of 3 months. (At baseline and at the end of each intervention period).
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The BDNF and the TNF will be measured by ELISA.
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An expected average of 3 months. (At baseline and at the end of each intervention period).
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Studie stoel: Wolnei Caumo, MD, PhD, Hospital de Clinicas de Porto Alegre
- Hoofdonderzoeker: Mônica Chassot, Federal University of Health Science of Porto Alegre
- Hoofdonderzoeker: Francislea C. Sehn, Federal University of Health Science of Porto Alegre
- Hoofdonderzoeker: Rafael Vercelino, Federal University of Health Science of Porto Alegre
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 09-259
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