The Effect of Transauricular Electrical Vagal Nerve Stimulation on Temporal Summation of Pain in Patients With Back Pain
NCT ID: NCT04503889
Last Updated: 2020-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2019-01-23
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Real taVNS intervention
taVNS will be administered to cymba conchae of both ears using ECO2-TENS device
Transauricular electrical vagal nerve stimulation
transauricular electrical vagal nerve stimulation will be applied to the cymba conchae of both ears using ECO2 TENS device (manufactured by Schwa-Medico GmbH/Germany) with currency intensity of max 10 mA and current frequency 2/100 Hz.
taVNS sham
ECO2 TENS device (manufactured by Schwa-Medico GmbH/Germany)
Sham
aVNS will be administered to lobes of both ears using ECO2-TENS device
Transauricular electrical vagal nerve stimulation
transauricular electrical vagal nerve stimulation will be applied to the cymba conchae of both ears using ECO2 TENS device (manufactured by Schwa-Medico GmbH/Germany) with currency intensity of max 10 mA and current frequency 2/100 Hz.
taVNS sham
ECO2 TENS device (manufactured by Schwa-Medico GmbH/Germany)
Interventions
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Transauricular electrical vagal nerve stimulation
transauricular electrical vagal nerve stimulation will be applied to the cymba conchae of both ears using ECO2 TENS device (manufactured by Schwa-Medico GmbH/Germany) with currency intensity of max 10 mA and current frequency 2/100 Hz.
taVNS sham
ECO2 TENS device (manufactured by Schwa-Medico GmbH/Germany)
Eligibility Criteria
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Inclusion Criteria
* age 30-60 yrs old
* without heart disease
* low-back pain intensity at least 4 out of 10 points measured using NRS-10
* without cognitive deficits (Mini Mental State Shake \< 23)
Exclusion Criteria
* more than 1 low-back surgery
* sensory of motor neurological deficits at the level of back pain
* spinal stenosis
* diabetic polyneuropathy
* skin pathology at the site (cymba conchae) of stimulation
30 Years
60 Years
ALL
Yes
Sponsors
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University Medicine Greifswald
OTHER
Responsible Party
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Principal Investigators
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Taras Usichenko, MD, PhD
Role: STUDY_CHAIR
University Medicine of Greifswald
Locations
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University Medicine of Greifswald
Greifswald, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BB 095/16
Identifier Type: -
Identifier Source: org_study_id
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