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

NCT07681336 | Recruiting

• 1 other identifier: MMS.2025.011
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

auricular vagus nerve stimulation; VIVO device

Outcome Measures

Primary Outcomes (1)

• Change in Oswestry Disability Index (ODI) from Baseline to 6 Weeks

  The primary outcome is the change in functional disability, measured using the Oswestry Disability Index (ODI), from baseline to the end of the treatment at 6 weeks. The ODI is a validated questionnaire assessing limitations in daily activities related to low back pain, with total scores ranging from 0 to 100, where higher scores indicate greater disability.

  Baseline to 6 weeks

Secondary Outcomes (13)

• Change in Oswestry Disability Index (ODI) over time

  Baseline to 12 months

• Change in pain intensity using Numeric Rating Scale (NRS)

  Baseline to 12 months

• Change in health-related quality of life using EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire

  Baseline to 12 months

• Change in anxiety and depression using Hospital Anxiety and Depression Scale (HADS)

  Baseline to 12 months

• Change in sleep quality using Pittsburgh Sleep Quality Index (PSQI)

  Baseline to 12 months

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Participants receive standard medical care for chronic low back pain. No VIVO® device is used in this group.

Other: Standard of Care (Investigator Choice)

VIVO® + Standard of Care

EXPERIMENTAL

Participants receive standard of care in combination with auricular vagus nerve stimulation using the VIVO® device for 6 weeks.

Device: Auricular Vagus Nerve Stimulation (VIVO®)

Interventions

Auricular Vagus Nerve Stimulation (VIVO®) DEVICE

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.

VIVO® + Standard of Care

Standard of Care (Investigator Choice) OTHER

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.

Standard of Care

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Algemeen Ziekenhuis Maria Middelares: lead

Study Sites (1)

AZ Maria Middelares

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Participants, care providers, and investigators are aware of the assigned treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist / Algologist

Model Details: Participants are randomized in a 1:1 ratio to receive either standard of care alone or standard of care in combination with auricular vagus nerve stimulation using the VIVO® device. Both groups are followed in parallel.

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: July 2, 2026
• Study Start: March 4, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)