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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
- Phase 3
Contacts et emplacements
Lieux d'étude
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brésil, 90035-003
- Hospital de Clinicas e Porto Alegre (HCPA)
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Electroacupuncture
All patients will receive 10 electroacupuncture sessions.
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Eletroacupuncture performed using acupuncture needles.
Autres noms:
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Comparateur factice: 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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pain Visual Analogue Scale (VAS)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Headache Impact Test (HIT-6)
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Biomarkers (BDNF nd TNF)
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Wolnei Caumo, MD, PhD, Hospital de Clinicas de Porto Alegre
- Chercheur principal: Mônica Chassot, Federal University of Health Science of Porto Alegre
- Chercheur principal: Francislea C. Sehn, Federal University of Health Science of Porto Alegre
- Chercheur principal: Rafael Vercelino, Federal University of Health Science of Porto Alegre
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 09-259
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