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

Primary Purpose

Pain Intensity

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Transauricular electrical vagal nerve stimulation
taVNS sham
Sponsored by
University Medicine Greifswald
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain Intensity

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Medicine of GreifswaldRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real taVNS intervention

Sham

Arm Description

taVNS will be administered to cymba conchae of both ears using ECO2-TENS device

aVNS will be administered to lobes of both ears using ECO2-TENS device

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Heart rate
Heart rate (bpm)
blood pressure
non-invasive measurement of systolic and diastolic blood pressure

Full Information

First Posted
July 31, 2020
Last Updated
August 6, 2020
Sponsor
University Medicine Greifswald
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1. Study Identification

Unique Protocol Identification Number
NCT04503889
Brief Title
The Effect of Transauricular Electrical Vagal Nerve Stimulation on Temporal Summation of Pain in Patients With Back Pain
Acronym
TVNS_TSP_LBP
Official Title
The Effect of Transauricular Electrical Vagal Nerve Stimulation on Temporal Summation of Heat Pain in Patients With Chronic Low-back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 23, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medicine Greifswald

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Intensity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participants and outcome assessor will be unaware regarding the type (real or sham) taVNS intervention
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Real taVNS intervention
Arm Type
Experimental
Arm Description
taVNS will be administered to cymba conchae of both ears using ECO2-TENS device
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
aVNS will be administered to lobes of both ears using ECO2-TENS device
Intervention Type
Device
Intervention Name(s)
Transauricular electrical vagal nerve stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
taVNS sham
Intervention Description
ECO2 TENS device (manufactured by Schwa-Medico GmbH/Germany)
Primary Outcome Measure Information:
Title
Unpleasantness of pain
Description
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)
Time Frame
Continuously 5 minutes during the experimental heat pain stimulation
Secondary Outcome Measure Information:
Title
Heart rate
Description
Heart rate (bpm)
Time Frame
10 minutes (before, during and after stimulation of heat pain)
Title
blood pressure
Description
non-invasive measurement of systolic and diastolic blood pressure
Time Frame
10 minutes (before, during and after stimulation of heat pain)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taras Usichenko, MD. PhD
Phone
+49 383486
Ext
5893
Email
taras@uni-greifswald.de
First Name & Middle Initial & Last Name or Official Title & Degree
David Naegele
Email
david.naegele@uni-greifswald.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taras Usichenko, MD, PhD
Organizational Affiliation
University Medicine of Greifswald
Official's Role
Study Chair
Facility Information:
Facility Name
University Medicine of Greifswald
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taras Usichenko, MD, hD
Phone
+49383486
Ext
5893
Email
taras@uni-greifswald.de
First Name & Middle Initial & Last Name & Degree
David Naegele
Email
david.naegele@uni-greifswald.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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