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Headache is a very frequent symptom among the world population, the adult population with an active headache disorder are 46% for headache in general, 11% for migraine, 42% for tension-type headache and 3% for chronic daily headache. There are different therapeutic approaches for the improvement of headache. Transcutaneous stimulation of the auricular vagal nerve is being used for the treatment of headache due to the involvement of the vagus nerve in inflammation and pain modulation. On the other hand, galvanic current has shown a measurable effect by increasing parasympathetic activity. The objective of this clinical trial is to stimulate the auricular vagal nerve with galvanic current using a needle as an electrode that will be inserted into the concha of the ear. As a tool for measuring results, infrared thermography will be used to observe changes in facial skin temperature, since patients with high sympathetic activity present a characteristic pattern of "cold nose" and/or "cold patch". In addition, variables that record changes in autonomic activity such as skin conductance and heart rate variability will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pecutaneous electrolysis group | Experimental | Subjects were treated twice (one day and one week). The technique consisted in the application of a galvanic electrical current using a needle as an electrode that will be inserted into the concha of the ear. The subjects were lying in supinus. |
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| dry needling group | Other | Subjects were treated twice (one day and one week). The technique consisted in the puncture with a needle in the concha of the ear. The subjects were lying in supinus. |
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| Sham group | Sham Comparator | Subjects were treated twice (one day and one week). The technique consisted in the puncture with a sham-needle in the concha of the ear. The subjects were lying in supinus. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| percutaneous needle electrolysis | Other | It´s an intervention of physiotherapy. It´s an invasive technique. |
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| Measure | Description | Time Frame |
|---|---|---|
| Skin temperature | It´s a camera to take infrared thermal images. The images provide facial temperature measurement. | Change from Baseline up to 30 minutes |
| Headache Impact Test (HIT-6) | Headache Impact (HIT) is a tool used to measure the impact headaches have on your ability to function at work, home, school and in social situations. Your score shows you the effect that headaches they have in normal daily life and in their ability to function.A score of 60 or higher is associated with a very severe impact. A score equal to or less than 49 is associated with a low impact. | Change from Baseline up to 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Skin bioimpedance | It´s a system to acquire bio-electrical and physiological signals (galvanic skin conductance, heart rate variability), and transfer these signals to a computer for processing an analysis. | Change from Baseline up to 30 minutes |
| Heart rate variability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Álvarez, Prof | Contact | +34 673 60 83 11 | fisioceano@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Pecos-Martin, PhD | Alcala University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physioterapy and Pain center research | Recruiting | Alcalá de Henares | Madrid | 28805 | Spain |
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| ID | Term |
|---|---|
| D006261 | Headache |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000079245 | Dry Needling |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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clinical random assignment
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triple (care provider, evaluator and outcome assessor)
| Dry needling | Other | It´s an intervention of physiotherapy. It´s an invasive technique. |
|
| Sham needling | Other | It´s an intervention of physiotherapy. It´s an invasive technique simulation. |
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It´s a system to acquire bio-electrical and physiological signals (galvanic skin conductance, heart rate variability), and transfer these signals to a computer for processing an analysis. |
| Change from Baseline up to 30 minutes |
| Numerical Rating Scale | Patients vebally requested to rate their pain: "Rate your pain from = (no pain) to 10 (unbearable pain) | Change from Baseline up to three months |
| Patients global impressions scale: | It´s the Patient reported outcomes counterpart to the Clinical Global Impressions scale. The PGIS are 1-item questionnaire that ask an individual patient to rate the severity of a specific condition (single-state scales) at baseline and or to rate at endpoint the perceived change in is/her condition in response to therapy; in the other hand PGIC measures change in clinical status. | Change from Baseline up to three months |
| Pittsburg Sleep Quality Index score | Improvement in Pittsburg Sleep Quality Index (PSQI), Scale is 0 to 21, higher score is worse outcome | Change from Baseline up to three months |