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Auricular Vagus Nerve Stimulation in Patients With High Impact Chronic Low Back Pain

NCT07681336 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-07-02

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate whether auricular vagus nerve stimulation using the VIVO® device can improve function and reduce pain in adults with high-impact chronic low back pain when added to standard medical care. It will also assess the safety and usability of this therapy.

The study includes adult patients aged 30 to 55 years who have had moderate to severe chronic low back pain for more than 6 months and who did not experience sufficient relief with standard pain treatments.

The main questions this study aims to answer are:

* Does adding the VIVO® device to standard care help people function better in daily life?
* Does the VIVO® device help lower pain and improve wellbeing, sleep, and quality of life?

Researchers will compare standard care plus VIVO® to standard care alone to see if the device improves outcomes.

Standard care may include medication, physiotherapy, or other usual treatments.

The main outcome is the change in disability (measured using the Oswestry Disability Index) after 6 weeks of treatment.

Participants will:

* Attend a baseline visit where medical history, physical examination, and questionnaires about pain, function, mood, sleep, and quality of life are collected;
* Be randomly assigned to one of the two treatment groups;
* Attend weekly visits for 6 weeks during the treatment phase;
* Keep a diary of their pain levels and any treatments or medications used;
* Complete questionnaires about pain, function, sleep, and wellbeing during the study.

Participants in the intervention group will:

Receive a VIVO® wearable device applied to the ear, which delivers electrical stimulation to the vagus nerve; Use the device continuously over 6 weeks, with weekly replacement and adjustment of stimulation settings; Be able to adjust the stimulation intensity themselves using a handheld device.

After the treatment period, all participants will be followed for 12 months, with additional visits or contacts to assess long-term effects, safety, and sustainability of the treatment.

Conditions

  • Chronic Low Back Pain

Interventions

DEVICE

Auricular Vagus Nerve Stimulation (VIVO®)

Auricular vagus nerve stimulation (aVNS) is delivered using the VIVO® device, a CE-marked wearable medical device that applies electrical stimulation to the auricular branch of the vagus nerve via electrodes placed on the ear. The device is worn continuously during a 6-week treatment period and replaced weekly, alternating between ears. Stimulation intensity is adjusted based on individual tolerance using a handheld controller. This intervention is administered in addition to standard of care.

OTHER

Standard of Care (Investigator Choice)

Participants receive standard medical care for chronic low back pain as determined by the treating physician. This may include pharmacological treatment, physiotherapy, behavioral therapy, and other non-invasive or invasive therapies as clinically indicated.

Sponsors & Collaborators

  • Algemeen Ziekenhuis Maria Middelares

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-04
Primary Completion
2027-09-30
Completion
2028-09-30

Countries

  • Belgium

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 NCT07681336 on ClinicalTrials.gov