SENECA - Smart Therapies for Chronic Pain

Official title

Efficacy of Percutaneous Auricular Vagus Nerve Stimulation Within the Multimodal Pain Therapy (SENECA): A Randomized Controlled Pilot Study

Overview

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 painDETECT, 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 (painDETECT, 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).

Interventions

• Device VIVO 2nd GEN
  VIVO 2nd GEN is a wearable medical device for personalized pain treatment through percutaneous auricular vagus nerve stimulation (pVNS). It is the next-generation device of the CE-marked pVNS device VIVO®, which is approved for chronic pain indications including chronic back pain. It is a battery-operated electrical stimulation device, to be placed behind the ear on the neck, and connects to three needle electrodes, which are placed in vagally innervated regions of the auricle. It emits electric
• Other Standard-of-Care Multimodal Pain Therapy
  The Standard-of-Care multimodal pain therapy includes specifically: physio group therapy, water therapy, strength training, Nordic walking, massages, thermos therapy, lectures and trainings, psychotherapy, local electrotherapy, medical evaluation

Primary outcome measures

• Oswestry Disability Index (ODI) [Time frame: Change from baseline to end of treatment (visit V5) at 4 weeks]

Secondary outcome measures (7)

• Questionnaire: Patient evaluation of device perception and usability [Time frame: Perception and usability of the VIVO 2nd GEN device is assessed at end of treatment (EoT) at 4 weeks. Perception and usability of the VIVO® Pal smartphone app is assessed at EoT at 4 weeks and at follow ups 4 weeks, 3 months and 6 months after EoT.]
• Questionnaire: Physicians' evaluation of device perception and usability [Time frame: Perception and usability of the VIVO 2nd GEN device assessed at end of treatment (EoT) at 4 weeks. Perception and usability of the VIVO® Pal smartphone app and web dashboard at EoT at 4 weeks and at follow ups 4 weeks, 3 months and 6 months after EoT.]
• Health-related quality of life questionnaire (EQ-5D-5L) [Time frame: 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.]
• Hospital Anxiety and Depression Scale (HADS) [Time frame: 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.]
• Pain Questionnaire painDETECT [Time frame: 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.]
• Smartphone-App Patient-Reported Outcomes [Time frame: Throughout the clinical investigation; from baseline to follow up (up to 6 months after end of treatment)]
• Socioeconomic Data Questionnaire [Time frame: 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.]

Eligibility criteria

Inclusion criteria

• 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 painDETECT subscale ≥ 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Austria · 1 center

• Klinikum Klagenfurt am Wörthersee — Klagenfurt

Identifiers

NCT: NCT07628179 · SENECA · S2025-10

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗