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Pilot Study of Vagal Stimulation in Chronic Low Back Pain

NCT05639270 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-09-13

No results posted yet for this study

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

Interventions

DEVICE

use of an auricular electrode

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

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-15
Primary Completion
2024-01-31
Completion
2024-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05639270 on ClinicalTrials.gov