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.
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);
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.);
Parallel
Auricular Vagus Nerve Stimulation (VIVO®)
DeviceAuricular 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 interventionParticipants 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.
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.
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.
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.
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.
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.
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