Chronic Low Back PainVIVONCT07681336
Auricular Vagus Nerve Stimulation in Patients With High Impact Chronic Low Back Pain
A study testing Auricular Vagus Nerve Stimulation (VIVO®) in people with Chronic Low Back Pain, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Auricular Vagus Nerve Stimulation (VIVO®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Mar 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 28Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
AZ Maria Middelares
Ghent, Oost-Vlaanderen, 9000
Nico Blyaert, +32 9 246 17 00, nicoblyaert@mijnziekenhuis.be
About this study
Official title: Auricular Vagus Nerve Stimulation in Patients With High Impact Chronic Low Back Pain - a Prospective, Interventional, Open, Randomized, Controlled, Single-center Trial
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.
Read more
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.
Read the detailed description
This is a prospective, interventional, open-label, randomized controlled, single-center clinical trial evaluating the effectiveness, safety, and usability of auricular vagus nerve stimulation using the VIVO® device in addition to standard of care in adults with high-impact chronic low back pain.
Chronic low back pain remains a major clinical challenge, as many people experience insufficient relief with currently available treatments. Standard approaches such as pharmacological therapy, physiotherapy, and multidisciplinary care often provide only partial improvement. There is therefore a need for additional non-pharmacological treatment options that may improve function and reduce pain.
Auricular vagus nerve stimulation (aVNS) is a minimally invasive neuromodulation technique that delivers electrical stimulation to the auricular branch of the vagus nerve. The VIVO® device is a CE-marked, wearable medical device that applies electrical impulses via small needle electrodes placed in the ear. This stimulation is thought to modulate pain processing through effects on the autonomic nervous system and central pain pathways, potentially supporting pain relief and improved function.
In this study, participants are randomized in a 1:1 ratio to receive either standard of care alone or standard of care combined with VIVO® therapy. The intervention period lasts 6 weeks. Participants in the intervention group receive a VIVO® device that is applied to the ear and replaced weekly, alternating between ears. The stimulation intensity is adjusted based on individual tolerance to achieve a comfortable sensation. Participants are also trained to adjust the stimulation amplitude using a handheld device.
Throughout the treatment period, participants attend regular study visits during which clinical assessments, patient-reported outcomes, and safety data are collected. During follow-up, participants are monitored for up to 12 months to evaluate the durability of treatment effects and to assess longer-term safety and usability.
The study is designed to evaluate whether the addition of aVNS therapy improves functional outcomes compared to standard of care alone. In addition, the study will explore the broader impact of treatment on pain experience, daily functioning, and patient-reported wellbeing. Usability of the device and participant satisfaction are also assessed to better understand how this therapy can be applied in clinical practice.
Safety monitoring will be conducted throughout the study, including the collection and evaluation of adverse events and device-related effects. The expected safety profile of aVNS is favorable, with mainly mild and local side effects such as skin irritation or discomfort at the application site.
The results of this study will provide further evidence on the role of auricular vagus nerve stimulation as a non-pharmacological treatment option for chronic low back pain and may help inform future patient selection and clinical use of this therapy.
- Conditions
- Chronic Low Back Pain
- Being tested
- Auricular Vagus Nerve Stimulation (VIVO®), Standard of Care (Investigator Choice)
- Keywords
- auricular vagus nerve stimulation, VIVO device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Participants receive standard medical care for chronic low back pain. No VIVO® device is used in this group. Receives: 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. Receives: Device: Auricular Vagus Nerve Stimulation (VIVO®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 weeks
Secondary outcomes (13)
Change in Oswestry Disability Index (ODI) over time
Change in functional disability measured using the Oswestry Disability Index (ODI) at predefined time points during the treatment period and follow-up visits. The ODI is a validated questionnaire assessing limitations in daily activities due to low back pain, with total scores ranging from 0 to 100, where higher scores indicate greater disability.
Measured: Baseline to 12 months
Change in pain intensity using Numeric Rating Scale (NRS)
Change in pain intensity measured using the Numeric Rating Scale (NRS) at predefined time points during the treatment period and follow-up visits. The NRS is a patient-reported scale ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity.
Measured: Baseline to 12 months
Change in health-related quality of life using EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire
Change in health-related quality of life measured using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire from baseline to the end of the treatment and follow-up visits. The EQ-5D-5L consists of a descriptive system assessing five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five levels of severity. Responses can be combined into a 5-digit health state profile, which can be converted into a single index value using a country-specific value set. Higher index scores indicate better health-related quality of life. The EQ visual analogue scale (EQ VAS) records the participant's self-rated health, where higher scores indicate better perceived health.
Measured: Baseline to 12 months
Change in anxiety and depression using Hospital Anxiety and Depression Scale (HADS)
Change in anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS) from baseline to the end of the treatment and follow-up visits. The HADS is a validated questionnaire consisting of two subscales (anxiety and depression), each ranging from 0 to 21, with higher scores indicating greater symptom severity.
Measured: Baseline to 12 months
Change in sleep quality using Pittsburgh Sleep Quality Index (PSQI)
Change in sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI) from baseline to the end of treatment and follow-up visits. The PSQI is a validated questionnaire assessing sleep quality, with total scores ranging from 0 to 21, where higher scores indicate worse sleep quality.
Measured: Baseline to 12 months
Change in neuropathic pain characteristics using Douleur Neuropathique 4 questionnaire (DN4)
Change in neuropathic pain characteristics measured using the Douleur Neuropathique 4 questionnaire (DN4) from baseline to the end of treatment and follow-up visits. The DN4 is a validated questionnaire used to identify neuropathic pain, with total scores ranging from 0 to 10, where higher scores indicate a greater likelihood of neuropathic pain.
Measured: Baseline to 12 months
Change in employment status over time
Change in employment status over time, assessed by recording participants' employment category (e.g., full-time employment, part-time employment, sick leave, invalidity, retirement) at predefined time points during the treatment period and follow-up.
Measured: Baseline to 12 weeks
Change in pain medication use assessed by medication type and frequency
Change in pain medication use over time, assessed by recording the type and frequency of analgesic medications used by participants at predefined time points during the study period.
Measured: Baseline to 12 months
Change in use of additional non-pharmacological therapies assessed by type and frequency
Change in the use of additional non-pharmacological therapies, including physiotherapy, assessed by recording the type and frequency of therapies received by participants at predefined time points during the study period.
Measured: Baseline to 12 months
Patient satisfaction and device usability assessed using a VIVO Perception & Usability questionnaire
Evaluation of patient-reported satisfaction with treatment and usability of the VIVO® device and its accessories, assessed using the VIVO® Perception \& Usability Scale, a manufacturer-developed 14-item questionnaire rated on a 5-point ordinal scale. This questionnaire is designed to measure patient perception and practical experience with the device. The assessment is performed once at the end of the treatment period.
Measured: At end of treatment period (week 6)
Physician and therapist satisfaction and device usability assessed using the VIVO® Perception & Usability Scale for Healthcare Professionals
Evaluation of physician and therapist satisfaction with treatment and usability of the VIVO® device and its accessories, assessed using the VIVO® Perception \& Usability Scale for Healthcare Professionals (HCPs), a manufacturer-developed 9-item questionnaire mostly rated on a 5-point ordinal scale. This questionnaire is designed to measure the perception and practical experience of healthcare professionals applying and treating patients with the VIVO® device. The assessment is performed once by the participating pain physician at the end of the treatment period for the last patient.
Measured: At end of treatment period (week 6, last patient)
Incidence of adverse events
Assessment of adverse events occurring during the treatment and follow-up period, including type, frequency, and severity of events, as reported and recorded at predefined time points.
Measured: Baseline to 12 months
Number of protocol deviations
Assessment of protocol deviations and non-conformities occurring during the study period, recorded throughout the treatment and follow-up period.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start4 Mar 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Algemeen Ziekenhuis Maria Middelares
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nico Blyaert, Algemeen Ziekenhuis Maria Middelares
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681336
- Sponsor's protocol ID
- MMS.2025.011
- Acronym
- VIVO
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. Data will be used for the purposes of this study and handled in accordance with applicable data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Vagus Nerve Stimulation in Patients With High Impact Chronic Low Back Pain - a Prospective, Interventional, Open, Randomized, Controlled, Single-center Trial
- ClinicalTrials.gov ID
- NCT07681336
- Acronym / sponsor ID
- VIVO / MMS.2025.011
- Conditions
- Chronic Low Back Pain
- Keywords
- auricular vagus nerve stimulation, VIVO device
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Algemeen Ziekenhuis Maria MiddelaresUniversity, hospital or other
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, interventional, open-label, randomized controlled, single-center clinical trial evaluating the effectiveness, safety, and usability of auricular vagus nerve stimulation using the VIVO® device in addition to standard of care in adults with high-impact chronic low back pain.
Chronic low back pain remains a major clinical challenge, as many people experience insufficient relief with currently available treatments. Standard approaches such as pharmacological therapy, physiotherapy, and multidisciplinary care often provide only partial improvement. There is therefore a need for additional non-pharmacological treatment options that may improve function and reduce pain.
Auricular vagus nerve stimulation (aVNS) is a minimally invasive neuromodulation technique that delivers electrical stimulation to the auricular branch of the vagus nerve. The VIVO® device is a CE-marked, wearable medical device that applies electrical impulses via small needle electrodes placed in the ear. This stimulation is thought to modulate pain processing through effects on the autonomic nervous system and central pain pathways, potentially supporting pain relief and improved function.
In this study, participants are randomized in a 1:1 ratio to receive either standard of care alone or standard of care combined with VIVO® therapy. The intervention period lasts 6 weeks. Participants in the intervention group receive a VIVO® device that is applied to the ear and replaced weekly, alternating between ears. The stimulation intensity is adjusted based on individual tolerance to achieve a comfortable sensation. Participants are also trained to adjust the stimulation amplitude using a handheld device.
Throughout the treatment period, participants attend regular study visits during which clinical assessments, patient-reported outcomes, and safety data are collected. During follow-up, participants are monitored for up to 12 months to evaluate the durability of treatment effects and to assess longer-term safety and usability.
The study is designed to evaluate whether the addition of aVNS therapy improves functional outcomes compared to standard of care alone. In addition, the study will explore the broader impact of treatment on pain experience, daily functioning, and patient-reported wellbeing. Usability of the device and participant satisfaction are also assessed to better understand how this therapy can be applied in clinical practice.
Safety monitoring will be conducted throughout the study, including the collection and evaluation of adverse events and device-related effects. The expected safety profile of aVNS is favorable, with mainly mild and local side effects such as skin irritation or discomfort at the application site.
The results of this study will provide further evidence on the role of auricular vagus nerve stimulation as a non-pharmacological treatment option for chronic low back pain and may help inform future patient selection and clinical use of this therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of Care (Investigator Choice)Participants receive standard medical care for chronic low back pain. No VIVO® device is used in this group. |
| VIVO® + Standard of Care | Experimental | Device: Auricular Vagus Nerve Stimulation (VIVO®)Participants receive standard of care in combination with auricular vagus nerve stimulation using the VIVO® device for 6 weeks. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (28 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | VIVO® + Standard of Care |
| 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. | Other | Standard of Care |
Primary outcome
Change in Oswestry Disability Index (ODI) from Baseline to 6 Weeks
Time frame: 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.
13 secondary outcomes
Change in Oswestry Disability Index (ODI) over time
Time frame: Baseline to 12 months
Change in pain intensity using Numeric Rating Scale (NRS)
Time frame: Baseline to 12 months
Change in health-related quality of life using EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire
Time frame: Baseline to 12 months
Change in anxiety and depression using Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline to 12 months
Change in sleep quality using Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline to 12 months
Change in neuropathic pain characteristics using Douleur Neuropathique 4 questionnaire (DN4)
Time frame: Baseline to 12 months
Change in employment status over time
Time frame: Baseline to 12 weeks
Change in pain medication use assessed by medication type and frequency
Time frame: Baseline to 12 months
Change in use of additional non-pharmacological therapies assessed by type and frequency
Time frame: Baseline to 12 months
Patient satisfaction and device usability assessed using a VIVO Perception & Usability questionnaire
Time frame: At end of treatment period (week 6)
Physician and therapist satisfaction and device usability assessed using the VIVO® Perception & Usability Scale for Healthcare Professionals
Time frame: At end of treatment period (week 6, last patient)
Incidence of adverse events
Time frame: Baseline to 12 months
Number of protocol deviations
Time frame: Baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. Data will be used for the purposes of this study and handled in accordance with applicable data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Vagus Nerve Stimulation (VIVO®) in people with Chronic Low Back Pain, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oswestry Disability Index (ODI) from Baseline to 6 Weeks (time frame: Baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.