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

University Medicine Greifswald

Status: Unknown

Conditions: Pain Intensity

Treatments: Device: taVNS sham; Device: Transauricular electrical vagal nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04503889

BB 095/16

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Real taVNS intervention

Experimental group

Description:

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

Treatment:

Device: taVNS sham

Device: Transauricular electrical vagal nerve stimulation

Sham

Sham Comparator group

Description:

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

Treatment:

Device: taVNS sham

Device: Transauricular electrical vagal nerve stimulation