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Completed

NCT Number: NCT01954277

Immune-Pineal Axis Function in Chronic Tension-Type Headache

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.

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Key information

Conditions

Chronic Tension-Type Headache

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital de Clinicas e Porto Alegre (HCPA)

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electroacupuncture

Device

Eletroacupuncture performed using acupuncture needles.

Other names: Electrical acupuncture

Placebo sham

Device

Placebo Sham is performed using electrodes, without electrical stimulation. Lights and sounds were identical to active treatment.

Other names: Placebo, Sham

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Federal University of Rio Grande do Sul

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 1, 2013
Registry last updated
Nov 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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