Chronic Tension-Type HeadachePhase 2/3NCT01954277
Immune-Pineal Axis Function in Chronic Tension-Type Headache
A Phase 2/3 study testing Electroacupuncture in people with Chronic Tension-Type Headache, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Chronic Tension-Type Headache
- What is being tested?
- Electroacupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2010to Nov 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas e Porto Alegre (HCPA)
Porto Alegre, Rio Grande do Sul, 90035-003
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Tension-Type Headache
- Being tested
- Electroacupuncture, Placebo Sham
- Keywords
- Chronic Tension-Type Headache, Electroacupuncture, Headache Impact, BDNF, TNF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureDevice
Also called Electrical acupuncture
Eletroacupuncture performed using acupuncture needles.
Placebo ShamDevice
Also called Placebo, Sham
Placebo Sham is performed using electrodes, without electrical stimulation. Lights and sounds were identical to active treatment.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture | Experimental | All patients will receive 10 electroacupuncture sessions. Receives: Device: Electroacupuncture |
| Placebo Sham | Sham comparator | All patients will receive 10 placebo sham sessions. Receives: Device: Placebo Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: An expected average of 3 months. (At baseline and at the end of each intervention period).
Secondary outcomes (1)
Headache Impact Test (HIT-6)
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.
Measured: An expected average of 3 months. (At baseline and at the end of each intervention period).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startOct 2010
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Tension-Type HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Wolnei Caumo, Hospital de Clinicas de Porto Alegre
- Investigators
- Wolnei Caumo, MD, PhD, Study chair, Hospital de Clinicas de Porto AlegreMônica Chassot, Principal investigator, Federal University of Health Science of Porto AlegreFrancislea C. Sehn, Principal investigator, Federal University of Health Science of Porto AlegreRafael Vercelino, Principal investigator, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954277
- Sponsor's protocol ID
- 09-259
- Status last verified
- Sep 2013
- First submitted
- 15 Sep 2013
- Last updated
- 18 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune-Pineal Axis Function in Chronic Tension-Type Headache: Noradrenergic Modulation and the Effect of Electroacupuncture
- ClinicalTrials.gov ID
- NCT01954277
- Acronym / sponsor ID
- 09-259
- Conditions
- Chronic Tension-Type Headache
- Keywords
- Chronic Tension-Type Headache, Electroacupuncture, Headache Impact, BDNF, TNF
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Oct 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 1 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture | Experimental | Device: ElectroacupunctureAll patients will receive 10 electroacupuncture sessions. |
| Placebo Sham | Sham comparator | Device: Placebo ShamAll patients will receive 10 placebo sham sessions. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureAlso: Electrical acupunctureEletroacupuncture performed using acupuncture needles. | Device | Electroacupuncture |
| Placebo ShamAlso: Placebo, ShamPlacebo Sham is performed using electrodes, without electrical stimulation. Lights and sounds were identical to active treatment. | Device | Placebo Sham |
Primary outcome
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).
1 secondary outcome
Headache Impact Test (HIT-6)
Time frame: An expected average of 3 months. (At baseline and at the end of each intervention period).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolnei Caumo, MD, PhD study chair
Hospital de Clinicas de Porto Alegre
Mônica Chassot principal investigator
Federal University of Health Science of Porto Alegre
Francislea C. Sehn principal investigator
Federal University of Health Science of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Electroacupuncture in people with Chronic Tension-Type Headache, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Visual Analogue Scale (VAS) (time frame: An expected average of 3 months. (At baseline and at the end of each intervention period).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2013.