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

Pain Intensity Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04503889
• Other study ID #: BB 095/16
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2019
• Est. completion date: December 2021

Study information

• Verified date: July 2020
• Source: University Medicine Greifswald
• Contact: Taras Usichenko, MD. PhD
• Phone: +49 383486
• Email: taras[@]uni-greifswald.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Pain
• Pain Intensity

Intervention

Device:
• Transauricular 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.
• taVNS sham
ECO2 TENS device (manufactured by Schwa-Medico GmbH/Germany)

Locations

Country	Name	City	State
Germany	University Medicine of Greifswald	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

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