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NCT07681336

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

Sponsor: Algemeen Ziekenhuis Maria Middelares

View on ClinicalTrials.gov

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.

Official title: Auricular Vagus Nerve Stimulation in Patients With High Impact Chronic Low Back Pain - a Prospective, Interventional, Open, Randomized, Controlled, Single-center Trial

Key Details

Gender

All

Age Range

30 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-03-04

Completion Date

2028-09

Last Updated

2026-07-02

Healthy Volunteers

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.

Inclusion Criteria: * Male or female patients aged ≥ 30 and ≤ 60 years; * High impact lumbar or lumbosacral myofascial/musculoskeletal chronic (\> 6 months) low back pain that is moderate to severe (defined as average pain over the last 4 weeks ≥ 5 on the NRS at baseline); * Normal function of lumbosacral nerves based on clinical assessment; * Unresponsive/intolerance (meaning insufficient pain reduction or intolerance) to oral pharmacotherapy (World Health Organization (WHO) grade II); * ODI 21-80 at baseline; * Patient understands the therapy and procedures, agrees to its provisions, and gives written informed consent prior to any procedures Exclusion Criteria: * Organic low back pain (trauma, fracture, tumor, infection, documented severe degenerative spine, documented high-grade spinal stenosis, rheumatologic conditions); * Indication for back surgery; * Radicular pain; * New analgesics 2 weeks before baseline (paracetamol, NSAIDs, etc.); * Opioid analgesic therapy; * Underwent other physical therapy modalities, including TENS, ultrasound, infiltration, RF-treatment, 2 weeks before screening; * History of Vagus Nerve Stimulation or ear stimulation; * History of vasovagal syncope; * BMI \> 35 kg/m² (Obesity Class 2 or higher); * Hemophilia; * Documented autonomic disorders; * Advanced stage or poorly controlled diabetes mellitus type I or II * Poorly controlled high blood pressure at baseline (systolic blood pressure (SBP) \> 160 mmHg); * Major psychiatric comorbidity (HADS ≥ 10 on each subscale at baseline); * Other serious clinically relevant co-morbidity, florid malignant conditions or neurological diseases; * History of arrhythmia, bradycardia, other rhythm disorders or any other clinically significant cardiac anomalies; * Use of prescription blood thinners, e.g., oral anticoagulants (marevan, sintrom, marcoumar), noval oral anticoagulants (pradaxa, xarelto, eliquis, lixiana), anti-platelet medication (asaflow); * Infection, eczema, or psoriasis at application site (ear and neck); * Numbed and desensitized skin at the application site (ear and neck); * Serious drug-related behavioral issues (e.g., alcohol dependency, illegal substance abuse) in the last 6 months; * Pregnant, parturient or breast-feeding women; * Active implantable device (e.g. cardiac pacemaker, defibrillator, cochlear implant, neurostimulator like Spinal Cord Stimulation or Peripheral Nerve Stimulation) ; * Currently participating in another interventional clinical trial or participated over the last 3 months; * Patients who are unable to sufficiently speak and write in the Dutch language; * Mental and physical impairments that represent a source of risk for handling the device; * Patients under legal protection (curatorship, guardianship); * Patients subject to a legal protection measure; * An adult who is incapable or unable to give consent.

Locations (1)

AZ Maria Middelares

Ghent, Oost-Vlaanderen, Belgium