Auricular Vagus Nerve Stimulation in Patients With High Impact Chronic Low Back Pain - a Prospective, Interventional, Open, Randomized, Controlled, Single-center Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in Oswestry Disability Index (ODI) from Baseline to 6 Weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study. Participants, care providers, and investigators are aware of the assigned treatment.
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Change in Oswestry Disability Index (ODI) from Baseline to 6 Weeks
时间窗: 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.
次要结局
- 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)
- Change in neuropathic pain characteristics using Douleur Neuropathique 4 questionnaire (DN4)(Baseline to 12 months)
- Change in employment status over time(Baseline to 12 weeks)
- Change in pain medication use assessed by medication type and frequency(Baseline to 12 months)
- Change in use of additional non-pharmacological therapies assessed by type and frequency(Baseline to 12 months)
- Patient satisfaction and device usability assessed using a VIVO Perception & Usability questionnaire(At end of treatment period (week 6))
- 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))
- Incidence of adverse events(Baseline to 12 months)
- Number of protocol deviations(Baseline to 12 months)
研究者
Nico Blyaert
Anesthesiologist / Algologist
Algemeen Ziekenhuis Maria Middelares