Pilot Study of Vagal Stimulation in Chronic Low Back Pain

NCT05639270 | Completed

• 1 other identifier: RECHMPL21_0598
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Low back pain is a major public health problem. It is the leading cause of disability in the world. The factors that lead to chronicity of low back pain are multi-factorial and are essentially represented by psychosocial factors (catastrophism, kinesiophobia, algophobia job dissatisfaction, emotional problems such as depression, anxiety, stress, injustice, etc.). Pain is a multimodal experience that involves different brain structures that are activated by the pain signal and involve the autonomic nervous system (ANS). The vagus nerve is the main actor of one of the two branches of the ANS, the parasympathetic system, which acts as a "slow-down". The vagus nerve participates in the inter-neuronal transmission of key neurotransmitters for mood, alertness, attention and motivation. Vagal stimulation has been used for many years as an analgesic device in chronic pain (vascular pain (facial vascular pain, fibromyalgia, visceral pain, gastrointestinal and pelvic pain...) To date, no study has been conducted on the value of vagal stimulation in chronic low back pain.

Conditions

Low Back Pain

Keywords

Vagus nerve stimulation; low back pain

Outcome Measures

Primary Outcomes (1)

• change from baseline pain at 1 month

  evaluated by a Visual Analog Scale (VAS, 0 the worst result and 100 the best result)

  between baseline and 1 month

Secondary Outcomes (18)

• change from baseline functional disability at 1 month

  between baseline and 1 month

• change from baseline functional disability at 3 month

  between baseline and 3 month

• change from baseline quality of life at 1 month

  between baseline and 1 month

• change from baseline quality of life at 3 month

  between baseline and 3 month

• change from baseline anxiety and depression at 1 month

  between baseline and 1 month

Study Arms (1)

low back pain

EXPERIMENTAL

The experimental intervention consists of vagal stimulation using the Tens Eco device with an auricular electrode and conductive gel. The stimulation will have an intensity of 25 Hz, lasting 30 minutes, once a day, for 3 months. An evaluation of the pain will be done every week by phone for the first month and then in consultation at one month and at 3 months.

Device: use of an auricular electrode

Interventions

use of an auricular electrode DEVICE

Use of the auricular electrode throughout the duration of the study (30minutes/day) combined with assessment of pain, tolerance, vagal tone.

low back pain

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Low back pain with a VAS greater than or equal to 40 that has been ongoing for more than 3 months
• Failed or insufficiently relieved by private physiotherapy
• Failed or insufficiently relieved or intolerant of level II analgesics
• No change in therapy envisaged within one month.

You may not qualify if:

• Non-common low back pain will not be accepted (presence of red flags).
• Auricular canal not adapted to the stimulation device.
• Use of another type of electrical device (pacemaker or TENS).
• History of vagotomy.
• Heart rhythm disorder.
• Presence of a cochlear implant on the stimulation side
• Pregnancy in progress or planned during the study period
• Adult protected by law or patient under guardianship or curator
• Person unable to give consent.
• Participation in other ongoing biomedical research
• Absence of express informed consent after a reflection period
• Not being affiliated to a French social security system or being a beneficiary of such a system

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (2)

CHU Montpellier

Montpellier, France, 34295, France

Location

CHU Nîmes - Le Grau du Roi

Nîmes, 30240, France

Location

Related Publications (1)

• Tavares-Figueiredo I, Pers YM, Duflos C, Herman F, Sztajnzalc B, Lecoq H, Laffont I, Dupeyron AF, Homs AF. Effect of Transcutaneous Auricular Vagus Nerve Stimulation in Chronic Low Back Pain: A Pilot Study. J Clin Med. 2024 Dec 13;13(24):7601. doi: 10.3390/jcm13247601.

  PMID: 39768526 RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 6, 2022
• Study Start: February 15, 2023
• Primary Completion: March 14, 2024
• Study Completion: March 14, 2024
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

FR (2)