ClinicalTrials.Veeva

Menu

Immune-Pineal Axis Function in Chronic Tension-Type Headache

H

Hospital de Clinicas de Porto Alegre

Status and phase

Completed
Phase 3
Phase 2

Conditions

Chronic Tension-Type Headache

Treatments

Device: Placebo Sham
Device: Electroacupuncture

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

34 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

34 participants in 2 patient groups

Electroacupuncture
Experimental group
Description:
All patients will receive 10 electroacupuncture sessions.
Treatment:
Device: Electroacupuncture
Placebo Sham
Sham Comparator group
Description:
All patients will receive 10 placebo sham sessions.
Treatment:
Device: Placebo Sham

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems