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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04503889

Acronym

TVNS_TSP_LBP

Enrollment

Registered

2020-08-07

Start date

2019-01-23

Completion date

2021-12-31

Last updated

2020-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Intensity

Brief summary

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.

Interventions

DEVICETransauricular 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.

DEVICEtaVNS sham

ECO2 TENS device (manufactured by Schwa-Medico GmbH/Germany)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

Participants and outcome assessor will be unaware regarding the type (real or sham) taVNS intervention

Eligibility

Sex/Gender

ALL

Age

30 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Unpleasantness of pain	Continuously 5 minutes during the experimental heat pain stimulation	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)

Secondary

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

Countries

Germany

Contacts

Primary ContactTaras Usichenko, MD. PhD

taras@uni-greifswald.de+49 383486

Backup ContactDavid Naegele

david.naegele@uni-greifswald.de

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026