Chronic Low Back Pain
Conditions
Keywords
auricular vagus nerve stimulation, VIVO device
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.
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.
Interventions
DEVICEAuricular 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.
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.
Sponsors
Algemeen Ziekenhuis Maria Middelares
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study. Participants, care providers, and investigators are aware of the assigned treatment.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oswestry Disability Index (ODI) from Baseline to 6 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oswestry Disability Index (ODI) over time | Baseline to 12 months | 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. |
| Change in pain intensity using Numeric Rating Scale (NRS) | Baseline to 12 months | 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. |
| Change in health-related quality of life using EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire | Baseline to 12 months | 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. |
| Change in anxiety and depression using Hospital Anxiety and Depression Scale (HADS) | Baseline to 12 months | 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. |
| Change in sleep quality using Pittsburgh Sleep Quality Index (PSQI) | Baseline to 12 months | 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. |
| Change in neuropathic pain characteristics using Douleur Neuropathique 4 questionnaire (DN4) | Baseline to 12 months | 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. |
| Change in employment status over time | Baseline to 12 weeks | 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. |
| Change in pain medication use assessed by medication type and frequency | Baseline to 12 months | 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. |
| Change in use of additional non-pharmacological therapies assessed by type and frequency | Baseline to 12 months | 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. |
| Patient satisfaction and device usability assessed using a VIVO Perception & Usability questionnaire | At end of treatment period (week 6) | 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. |
| Physician and therapist satisfaction and device usability assessed using the VIVO® Perception & Usability Scale for Healthcare Professionals | At end of treatment period (week 6, last patient) | 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. |
| Incidence of adverse events | Baseline to 12 months | 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. |
| Number of protocol deviations | Baseline to 12 months | Assessment of protocol deviations and non-conformities occurring during the study period, recorded throughout the treatment and follow-up period. |
Countries
Belgium
Outcome results
None listed