Efficacy of Percutaneous Auricular Vagus Nerve Stimulation Within the Multimodal Pain Therapy (SENECA): A Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Aurimod GmbH
- 入组人数
- 44
- 试验地点
- 1
研究概览
简要总结
This will be a randomized controlled prospective pilot study: The feasibility and usability of VIVO 2nd GEN therapy + Standard-of-Care (SoC) vs. Standard-of-Care alone will be evaluated.
At baseline, after informed consent and evaluation of inclusion and exclusion criteria, evaluation of pain on Numerical and qualitative pain rating scales, quality of life (EQ-5D-5L questionnaire), mental health (HADS questionnaire), and the effect of back pain on function and daily activities (ODI questionnaire) will be performed. After that, all patients will start their multimodal treatment plan.
The control group will only receive SoC multimodal therapy training (this includes specifically: physio group therapy, water therapy, strength training, Nordic walking, massages, thermos therapy, lectures and trainings, psychotherapy, local electrotherapy).
The treatment group will additionally receive pVNS as add-on therapy. Within this study the next generation device VIVO 2nd GEN will be used within a pVNS proofed indication.
The study documentation in both groups will be supported by a digital diary App (VIVO® Pal) and an online dashboard for physicians/therapists (Therapy Management System - TMS), allowing for pseudonymized data entries and management.
Patients will remain on treatment for 4 weeks. All patients will be evaluated using questionnaires (Numerical and qualitative pain rating scales, EQ-5D-5L, HADS, ODI) at baseline, weekly during treatment for 4 weeks, by end of treatment and at 4 weeks (optional 3 months and 6 months) follow-up (e.g., via telephone or the App, see below).
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
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged between 30 and 65 years
- •Indication: chronic myofascial/musculoskeletal back pain
- •normal function of spinal nerves
- •Intractable pain for more than 6 months
- •Patient on oral pharmacotherapy ≤ WHO II with no adequate response or intolerant
- •Average pain over the last 4 weeks according to the 0-10 numerical pain rating scale ≥ 4 and ≤ 9 at baseline
- •ODI 20-80 at baseline
- •Basic digital understanding to work with the patient pain app
- •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, severe degenerative spine, documented high-grade spinal stenosis, rheumatologic conditions)
- •Indication for back surgery
- •Back surgery within the last 6 months
- •New analgesics 2 weeks before baseline (paracetamol, NSAIDs, Metamizol, etc.)
- •Opioid analgesic therapy > WHO II
- •New physical therapy modalities for back pain, also TENS, 2 weeks before baseline
- •History of vagus nerve stimulation or electrical auricular stimulation
- •History of vasovagal syncope
- •High BMI > 35 kg/m² (Obesity Class 2 or higher)
- •Hemophilia
- •Autonomic disorders
- •Advanced stage or poorly controlled diabetes mellitus type I or II
- •Poorly controlled high blood pressure
- •Major psychiatric comorbidity (HADS > 10 on each subscale at baseline)
- •Other serious clinically relevant co-morbidity
- •History of arrhythmia, bradycardia, other rhythm disorders or any other clinically significant cardiac anomalies
- •Infection, eczema, or psoriasis at application site (ear and neck)
- •Numbed and desensitized skin at the application site (ear and neck)
- •Chronic drug or alcohol abuse within the last 6 months
- •Pregnant or nursing female patients
- •Active implantable device
- •Open pension request
- •Currently participating in another clinical trial or participated over the last 3 months
- •Change in concomitant treatment or medication during the study
研究组 & 干预措施
Standard-of-Care + VIVO 2nd GEN
Standard-of-Care 4-week multimodal pain therapy for chronic pain patients (this includes specifically: physio group therapy, water therapy, strength training, Nordic walking, massages, thermos therapy, lectures and trainings, psychotherapy, local electrotherapy) will be combined with the VIVO 2nd GEN wearable medical device for personalized pain treatment through percutaneous auricular vagus nerve stimulation (paVNS).
干预措施: VIVO 2nd GEN (Device)
Standard-of-Care (SoC)
SoC multimodal therapy training (this includes specifically: physio group therapy, water therapy, strength training, Nordic walking, massages, thermos therapy, lectures and trainings, psychotherapy, local electrotherapy).
干预措施: Standard-of-Care Multimodal Pain Therapy (Other)
Standard-of-Care + VIVO 2nd GEN
Standard-of-Care 4-week multimodal pain therapy for chronic pain patients (this includes specifically: physio group therapy, water therapy, strength training, Nordic walking, massages, thermos therapy, lectures and trainings, psychotherapy, local electrotherapy) will be combined with the VIVO 2nd GEN wearable medical device for personalized pain treatment through percutaneous auricular vagus nerve stimulation (paVNS).
干预措施: Standard-of-Care Multimodal Pain Therapy (Other)
结局指标
主要结局
未指定
次要结局
- Numerical and qualitative pain rating scales(Change from baseline to end-of-treatment at 4 weeks and to follow up at 4 weeks, 3 months, and 6 months after end-of-treatment.)