Ignite Creation Date:
2024-05-06 @ 2:01 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01954277
Status:
COMPLETED
Last Update Posted:
2013-11-18
First Post:
2013-09-15
Brief Title:
Immune-Pineal Axis Function in Chronic Tension-Type Headache
Sponsor:
Hospital de Clinicas de Porto Alegre
Organization:
Hospital de Clinicas de Porto Alegre
Study Overview
Official Title:
Immune-Pineal Axis Function in Chronic Tension-Type Headache Noradrenergic Modulation and the Effect of Electroacupuncture
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None