The Effect of Transauricular Electrical Vagal Nerve Stimulation on Temporal Summation of Pain in Patients With Back Pain

Study Overview
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Brief Summary
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The effect of transauricular electrical vagal nerve stimulation (taVNS) will be studied on temporal summation of heat pain (TSP) in 30 patients with chronic low-back pain and in 30 heathy volunteers. Participants will receive either taVNS or sham stimulation before and during TSP induction in a randomized crossover manner. The participants will be unaware regarding the type of intervention.

Official Title
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The Effect of Transauricular Electrical Vagal Nerve Stimulation on Temporal Summation of Heat Pain in Patients With Chronic Low-back Pain

Conditions
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Pain Intensity

Intervention / Treatment
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* Device: Transauricular electrical vagal nerve stimulation
* Device: taVNS sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chronic low-back pain 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: opioid medication 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real taVNS intervention<br>taVNS will be administered to cymba conchae of both ears using ECO2-TENS device | Device: Transauricular electrical vagal nerve stimulation<br>* 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.<br>Device: taVNS sham<br>* ECO2 TENS device (manufactured by Schwa-Medico GmbH/Germany)<br>|
| Sham Comparator: Sham<br>aVNS will be administered to lobes of both ears using ECO2-TENS device | Device: Transauricular electrical vagal nerve stimulation<br>* 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.<br>Device: taVNS sham<br>* ECO2 TENS device (manufactured by Schwa-Medico GmbH/Germany)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unpleasantness of pain | Perceived unpleasantness of pain, which participants will rate continuously during the repetitive heat stimulation using a computerized visual analogue scale (CoVAS, Medoc Advanced Medical Systems, Ramat Yishai, Israel) ranging from 0 (= not unpleasant at all) to 100 (= intolerable pain) | Continuously 5 minutes during the experimental heat pain stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Heart rate (bpm) | 10 minutes (before, during and after stimulation of heat pain) | 
| blood pressure | non-invasive measurement of systolic and diastolic blood pressure | 10 minutes (before, during and after stimulation of heat pain) |