Immune-Pineal Axis Function in Chronic Tension-Type Headache

NCT01954277 | Completed Phase 2 DMC

• 1 other identifier: 09-259
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Tension-Type Headache

Keywords

Chronic Tension-Type Headache; Electroacupuncture; Headache Impact; BDNF; TNF

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (1)

• Headache Impact Test (HIT-6)

  An expected average of 3 months. (At baseline and at the end of each intervention period).

Other Outcomes (1)

• Biomarkers (BDNF nd TNF)

  An expected average of 3 months. (At baseline and at the end of each intervention period).

Study Arms (2)

Electroacupuncture

EXPERIMENTAL

All patients will receive 10 electroacupuncture sessions.

Device: Electroacupuncture

Placebo Sham

SHAM COMPARATOR

All patients will receive 10 placebo sham sessions.

Device: Placebo Sham

Interventions

Electroacupuncture DEVICE

Eletroacupuncture performed using acupuncture needles.

Also known as: Electrical acupuncture

Electroacupuncture

Placebo Sham DEVICE

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

Also known as: Placebo, Sham

Placebo Sham

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Federal University of Rio Grande do Sul: collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Hospital de Clinicas e Porto Alegre (HCPA)

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

Location

MeSH Terms

Interventions

Electroacupuncture

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Wolnei Caumo, MD, PhD

  Hospital de Clinicas de Porto Alegre

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor and coordinator of Pain & Neuromodulation Lab

Study Record Dates

• First Submitted: September 15, 2013
• First Posted: October 1, 2013
• Study Start: October 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 18, 2013

Record last verified: 2013-09

Locations

BR (1)