Immune-Pineal Axis Function in Chronic Tension-Type Headache

Phase 2

Completed

• Conditions: Chronic Tension-Type Headache
• Interventions: Device: Electroacupuncture; Device: Placebo Sham

• Registration Number: NCT01954277
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study Start: 2010-10
• Status Verified: 2013-09
• Study First Submitted: 2013-09-15
• Study First Submitted QC: 2013-09-26
• Primary Completion: 2013-10
• Study First Posted: 2013-10-01
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-15
• Last Update Posted: 2013-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Electroacupuncture	Electroacupuncture	All patients will receive 10 electroacupuncture sessions.
Placebo Sham	Placebo Sham	All patients will receive 10 placebo sham sessions.

Primary Outcome Measures

Name	Time	Method
Pain Visual Analogue Scale (VAS)	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).

Secondary Outcome Measures

Name	Time	Method
Headache Impact Test (HIT-6)	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.

Trial Locations

Locations (1)

Hospital de Clinicas e Porto Alegre (HCPA); 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil