Auricular vagus nerve stimulation added to care for high-impact chronic low back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, open-label, randomized trial evaluates the safety and usability of the VIVO auricular vagus nerve stimulation device in adults with high-impact chronic low back pain when used with standard care. Participants are randomized 1:1 to receive standard care plus VIVO or standard care alone for a 6-week intervention period at a single center. The study aims to measure changes in disability, pain, wellbeing, sleep, and quality of life, with standard care consisting of medications, physiotherapy, or other usual treatments. The device is worn on the ear and delivers electrical stimulation via needle electrodes, with weekly replacements. The trial seeks to determine if the VIVO device provides additional functional and symptomatic benefits beyond standard care, while monitoring safety and usability.

Why it matters

Who can join: the full rules

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.

Where it's running

• AZ Maria Middelares
  Ghent, Oost-Vlaanderen, Belgium Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.