Immune-Pineal Axis Function in Chronic Tension-Type Headache

November 15, 2013 updated by: Wolnei Caumo, Hospital de Clinicas de Porto Alegre

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

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.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
        • Hospital de Clinicas e Porto Alegre (HCPA)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electroacupuncture
All patients will receive 10 electroacupuncture sessions.
Eletroacupuncture performed using acupuncture needles.
Other Names:
  • Electrical acupuncture
Sham Comparator: Placebo Sham
All patients will receive 10 placebo sham sessions.
Placebo Sham is performed using electrodes, without electrical stimulation. Lights and sounds were identical to active treatment.
Other Names:
  • Placebo
  • Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Visual Analogue Scale (VAS)
Time Frame: An expected average of 3 months. (At baseline and at the end of each intervention period).
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).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache Impact Test (HIT-6)
Time Frame: An expected average of 3 months. (At baseline and at the end of each intervention period).
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).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers (BDNF nd TNF)
Time Frame: An expected average of 3 months. (At baseline and at the end of each intervention period).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Wolnei Caumo, MD, PhD, Hospital de Clinicas de Porto Alegre
  • Principal Investigator: Mônica Chassot, Federal University of Health Science of Porto Alegre
  • Principal Investigator: Francislea C. Sehn, Federal University of Health Science of Porto Alegre
  • Principal Investigator: Rafael Vercelino, Federal University of Health Science of Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

September 15, 2013

First Submitted That Met QC Criteria

September 26, 2013

First Posted (Estimate)

October 1, 2013

Study Record Updates

Last Update Posted (Estimate)

November 18, 2013

Last Update Submitted That Met QC Criteria

November 15, 2013

Last Verified

September 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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