Pain IntensityTVNS_TSP_LBPNCT04503889
The Effect of Transauricular Electrical Vagal Nerve Stimulation on Temporal Summation of Pain in Patients With Back Pain
A study testing Transauricular electrical vagal nerve stimulation in people with Pain Intensity, run by University Medicine Greifswald at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Intensity
- What is being tested?
- Transauricular electrical vagal nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 23 Jan 2019to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
David Naegele contact
Germany1 site, 1 recruiting
- Recruiting
University Medicine of Greifswald
Greifswald, 17475
Taras Usichenko, MD, hD, +49383486 ext. 5893, taras@uni-greifswald.de
David Naegele, david.naegele@uni-greifswald.de
About this study
Official title: The Effect of Transauricular Electrical Vagal Nerve Stimulation on Temporal Summation of Heat Pain in Patients With Chronic Low-back Pain
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.
- Conditions
- Pain Intensity
- Being tested
- Transauricular electrical vagal nerve stimulation, taVNS sham
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transauricular electrical vagal nerve stimulationDevice
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 shamDevice
ECO2 TENS device (manufactured by Schwa-Medico GmbH/Germany)
| Study group | Role | What they receive |
|---|---|---|
| Real taVNS intervention | Experimental | taVNS will be administered to cymba conchae of both ears using ECO2-TENS device Receives: Device: Transauricular electrical vagal nerve stimulation; Device: taVNS sham |
| Sham | Sham comparator | aVNS will be administered to lobes of both ears using ECO2-TENS device Receives: Device: Transauricular electrical vagal nerve stimulation; Device: taVNS sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Continuously 5 minutes during the experimental heat pain stimulation
Secondary outcomes (2)
Heart rate
Heart rate (bpm)
Measured: 10 minutes (before, during and after stimulation of heat pain)
blood pressure
non-invasive measurement of systolic and diastolic blood pressure
Measured: 10 minutes (before, during and after stimulation of heat pain)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start23 Jan 2019
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain IntensityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Taras Usichenko, MD, PhD, Study chair, University Medicine of Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503889
- Sponsor's protocol ID
- BB 095/16
- Acronym
- TVNS_TSP_LBP
- Status last verified
- Jul 2020
- First submitted
- 31 Jul 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transauricular Electrical Vagal Nerve Stimulation on Temporal Summation of Heat Pain in Patients With Chronic Low-back Pain
- ClinicalTrials.gov ID
- NCT04503889
- Acronym / sponsor ID
- TVNS_TSP_LBP / BB 095/16
- Conditions
- Pain Intensity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real taVNS intervention | Experimental | Device: Transauricular electrical vagal nerve stimulation, Device: taVNS shamtaVNS will be administered to cymba conchae of both ears using ECO2-TENS device |
| Sham | Sham comparator | Device: Transauricular electrical vagal nerve stimulation, Device: taVNS shamaVNS will be administered to lobes of both ears using ECO2-TENS device |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- opioid medication
- more than 1 low-back surgery
- sensory of motor neurological deficits at the level of back pain
- spinal stenosis
- diabetic polyneuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transauricular electrical vagal nerve stimulationtransauricular 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. | Device | Real taVNS intervention, Sham |
| taVNS shamECO2 TENS device (manufactured by Schwa-Medico GmbH/Germany) | Device | Real taVNS intervention, Sham |
Primary outcome
Unpleasantness of pain
Time frame: 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)
2 secondary outcomes
Heart rate
Time frame: 10 minutes (before, during and after stimulation of heat pain)
blood pressure
Time frame: 10 minutes (before, during and after stimulation of heat pain)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Naegele contact
Taras Usichenko, MD, PhD study chair
University Medicine of Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transauricular electrical vagal nerve stimulation in people with Pain Intensity, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Taras Usichenko, MD. PhD (+49 383486 ext. 5893, taras@uni-greifswald.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unpleasantness of pain (time frame: Continuously 5 minutes during the experimental heat pain stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.