SENECA - Smart Therapies for Chronic Pain

Summary

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).

Conditions

• Chronic Low Back Pain (CLBP)

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 electrical signals with a defined set of parameters, i.e., fixed pulse width, fixed frequency, fixed bursted stimulation, but with adjustable amplitude and fixed duty cycle. It is smaller and lighter than VIVO® and the stimulator is re-usable with single-use battery pack and needle electrodes. Stimulation parameters are equal to VIVO®.

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

Sponsors & Collaborators

• AIT Austrian Institute of Technology GmbH

  collaborator OTHER

• Aurimod GmbH

  lead INDUSTRY

Principal Investigators

• Rudolf Likar, Prim. Univ.-Prof. Dr. MSc. · Klinikum Klagenfurt am Wörthersee

• Thomas Ettenauer, Dr. · Klinikum Klagenfurt am Wörthersee

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-17

Primary Completion

2027-03-31

Completion

2027-04-30

Countries

• Austria

Study Locations