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

Not Applicable

• Conditions: Pain Intensity
• Interventions: Device: Transauricular electrical vagal nerve stimulation; Device: taVNS sham

• Registration Number: NCT04503889
• Lead Sponsor: University Medicine Greifswald

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-23
• Status Verified: 2020-07
• Study First Submitted: 2020-07-31
• Study First Submitted QC: 2020-08-06
• Last Update Submitted: 2020-08-06
• Study First Posted: 2020-08-07
• Last Update Posted: 2020-08-07
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Real taVNS intervention	Transauricular electrical vagal nerve stimulation	taVNS will be administered to cymba conchae of both ears using ECO2-TENS device
Real taVNS intervention	taVNS sham	taVNS will be administered to cymba conchae of both ears using ECO2-TENS device
Sham	Transauricular electrical vagal nerve stimulation	aVNS will be administered to lobes of both ears using ECO2-TENS device
Sham	taVNS sham	aVNS will be administered to lobes of both ears using ECO2-TENS device

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Medicine of Greifswald; 🇩🇪 Greifswald, Germany