Immune-Pineal Axis Function in Chronic Tension-Type Headache

Chronic Tension-Type Headache Clinical Trial

Official title:

Immune-Pineal Axis Function in Chronic Tension-Type Headache: Noradrenergic Modulation and the Effect of Electroacupuncture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01954277
• Other study ID #: 09-259
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 15, 2013
• Last updated: November 15, 2013
• Start date: October 2010
• Est. completion date: November 2013

Study information

• Verified date: September 2013
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Tension-Type Headache
• Headache
• Tension-Type Headache

Intervention

Device:
• Electroacupuncture
Eletroacupuncture performed using acupuncture needles.
• Placebo Sham
Placebo Sham is performed using electrodes, without electrical stimulation. Lights and sounds were identical to active treatment.

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas e Porto Alegre (HCPA)	Porto Alegre	Rio Grande do Sul

Sponsors (3)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biomarkers (BDNF nd TNF)	The BDNF and the TNF will be measured by ELISA.	An expected average of 3 months. (At baseline and at the end of each intervention period).	No
Primary	Pain Visual Analogue Scale (VAS)	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).	An expected average of 3 months. (At baseline and at the end of each intervention period).	No
Secondary	Headache Impact Test (HIT-6)	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.	An expected average of 3 months. (At baseline and at the end of each intervention period).	No