Could a gentle zap to the ear ease stubborn back pain?

NCT ID NCT07681336

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study tests whether a wearable device that gently stimulates a nerve in the ear can help people with long-term, hard-to-treat low back pain. Adults aged 30 to 60 with moderate to severe pain for over six months will either receive standard care alone or standard care plus the ear stimulation device for six weeks. Researchers will measure changes in daily function, pain, sleep, and quality of life, and follow participants for a year to see if any benefits last.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
auricular vagus nerve stimulation device (VIVO®)
What this could lead to
If it works, this could offer a drug-free option to help people with stubborn back pain move better and feel less pain.
What could go wrong
This is a small, early-stage trial, so results may not apply to everyone. The device may not work better than standard care, and some people may find the ear stimulation uncomfortable.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 44 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

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How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • AZ Maria Middelares

    RECRUITING

    Ghent, Oost-Vlaanderen, 9000, Belgium

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