The Effect of Transauricular Electrical Vagal Nerve Stimulation on Temporal Summation of Pain in Patients With Back Pain
TVNS_TSP_LBP
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 23, 2019
CompletedFirst Submitted
Initial submission to the registry
July 31, 2020
CompletedFirst Posted
Study publicly available on registry
August 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedAugust 7, 2020
July 1, 2020
2.9 years
July 31, 2020
August 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Heart rate
10 minutes (before, during and after stimulation of heat pain)
blood pressure
10 minutes (before, during and after stimulation of heat pain)
Study Arms (2)
Real taVNS intervention
EXPERIMENTALtaVNS will be administered to cymba conchae of both ears using ECO2-TENS device
Sham
SHAM COMPARATORaVNS will be administered to lobes of both ears using ECO2-TENS device
Interventions
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.
ECO2 TENS device (manufactured by Schwa-Medico GmbH/Germany)
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medicine of Greifswald
Greifswald, 17475, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Taras Usichenko, MD, PhD
University Medicine of Greifswald
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Participants and outcome assessor will be unaware regarding the type (real or sham) taVNS intervention
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2020
First Posted
August 7, 2020
Study Start
January 23, 2019
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
August 7, 2020
Record last verified: 2020-07