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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
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.
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.
AZ Maria Middelares
Ghent, Oost-Vlaanderen, Belgium
RECRUITINGChange 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.
Time frame: Baseline to 6 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 12 months
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