Chronic Low Back Pain (CLBP)SENECANCT07628179
SENECA - Smart Therapies for Chronic Pain
A study testing VIVO 2nd GEN and Standard-of-Care Multimodal Pain Therapy in people with Chronic Low Back Pain (CLBP), run by Aurimod GmbH at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Chronic Low Back Pain (CLBP)
- What is being tested?
- VIVO 2nd GEN and Standard-of-Care Multimodal Pain Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteAustria
- Study dates
- 17 Sep 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Carinthia, 9020
Hans-Jürgen Gallowitsch, Univ.-Doz. Dr., +43 463 538-31000, md.klagenfurt@kabeg.at
About this study
Official title: Efficacy of Percutaneous Auricular Vagus Nerve Stimulation Within the Multimodal Pain Therapy (SENECA): A Randomized Controlled Pilot Study
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.
Read more
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)
- Being tested
- VIVO 2nd GEN, Standard-of-Care Multimodal Pain Therapy
- Keywords
- auricular vagus nerve stimulation, chronic pain, neuromodulation, multimodal pain therapy, digital therapy management
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIVO 2nd GENDevice
Also called auricular vagus nerve stimulation, percutaneous auricular vagus nerve stimulation
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®.
Standard-of-Care Multimodal Pain TherapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-Care + VIVO 2nd GEN | Experimental | 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). Receives: Device: VIVO 2nd GEN; Other: Standard-of-Care Multimodal Pain Therapy |
| Standard-of-Care (SoC) | Other | 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). Receives: Other: Standard-of-Care Multimodal Pain Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
Questionnaire for assessing functional status and quality-of-life impairment in patients with low back pain or spinal cord disease and injury. The ODI score ranges from 0 - 100%, with higher scores indicating a more severe disability
Measured: Change from baseline to end of treatment (visit V5) at 4 weeks
Secondary outcomes (7)
Questionnaire: Patient evaluation of device perception and usability
Patient evaluation of perception and usability of the VIVO 2nd GEN investigational medical device and the VIVO® Pal smartphone app using questionnaires.
Patients rate agreement with statements on ease of use, tolerability, wearing comfort of the investigational medical device (e.g. "The device was easy to use", "I quickly got used to the device") on scales from 1 (does not apply at all) to 5 (fully applies). Patients rate interference of the device with everyday activities separately for each of 9 activities as "unchanged", "more difficult" and "much more difficult".
Patients rate agreement with statements on ease of use, functionality and optic impression of the accompanying smartphone app on scales from 1 (does not apply at all) to 5 (fully applies).
Measured: 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
Physician's evaluation of satisfaction with therapy and usability of VIVO 2nd GEN device, VIVO® Pal (smartphone app) and therapy management system (web dashboard) using questionnaires.
Physicians rate agreement with statements application and adjustment of the device (e.g. "After training, it was easy to correctly apply the device") on scales from 1 (does not apply at all) to 5 (fully applies). Physicians rate agreement with statements on ease of use, functionality and optic impression of the accompanying smartphone app and web dashboard on scales from 1 (does not apply at all) to 5 (fully applies).
Measured: 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)
Health-related quality of life is reported by patients using the EuroQOL 5 dimensions, 5 levels questionnaire. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
On the EQ VAS, patients rate their health on a vertical visual analogue scale where endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Measured: 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)
The HADS serves as a self-report instrument to assess anxiety and depression, particularly in medical settings. It comprises 14 items, evenly split between two subscales: seven items assessing anxiety and seven evaluating depression. Each item focuses on emotional symptoms, such as feeling tense or cheerful, using a 4-point Likert scale ranging from 0 (not at all) to 3 (most of the time). Total scores range from 0 to 42, with higher scores indicating greater symptom severity.
Measured: 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.
Numerical and qualitative pain rating scales
Numerical and qualitative pain rating scales are used to rate pain intensity and pain quality. Pain intensity is rated at the current moment, as well as worst pain and average pain during the previous four weeks on numerical rating scales (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain). Pain quality is evaluated by selecting between four categories.
Measured: 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
Within the VIVO Pal smartphone applications, patients are encouraged to enter additional patient reported outcomes on overall wellbeing, sleep, mobility, and pain. These items are rated on 5-point-scales ranging from "very bad" to "very good". Patients can also enter their medication throughout the study (in addition to concomitant medication querying by the investigator at in-patient and telemedical visit).
Measured: Throughout the clinical investigation; from baseline to follow up (up to 6 months after end of treatment)
Socioeconomic Data Questionnaire
Patients report socioeconomic data like work status (working, full time/part time, sick leave, retired, etc.)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start17 Sep 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aurimod GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AIT Austrian Institute of Technology GmbH
- Responsible party
- Sponsor
- Investigators
- Rudolf Likar, Prim. Univ.-Prof. Dr. MSc., Principal investigator, Klinikum Klagenfurt am WörtherseeThomas Ettenauer, Dr., Principal investigator, Klinikum Klagenfurt am Wörthersee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628179
- Sponsor's protocol ID
- SENECA
- Other IDs
- S2025-10
- Acronym
- SENECA
- Status last verified
- Aug 2026
- First submitted
- 19 May 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Percutaneous Auricular Vagus Nerve Stimulation Within the Multimodal Pain Therapy (SENECA): A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT07628179
- Acronym / sponsor ID
- SENECA / SENECA
- Conditions
- Chronic Low Back Pain (CLBP)
- Keywords
- auricular vagus nerve stimulation, chronic pain, neuromodulation, multimodal pain therapy, digital therapy management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Aurimod GmbHIndustry (pharma, biotech, devices)
- Collaborators
- AIT Austrian Institute of Technology GmbH
- Study start
- 17 Sep 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard-of-Care + VIVO 2nd GEN | Experimental | Device: VIVO 2nd GEN, Other: Standard-of-Care Multimodal Pain TherapyStandard-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). |
| Standard-of-Care (SoC) | Other | Other: Standard-of-Care Multimodal Pain TherapySoC multimodal therapy training (this includes specifically: physio group therapy, water therapy, strength training, Nordic walking, massages, thermos therapy, lectures and trainings, psychotherapy, local electrotherapy). |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIVO 2nd GENAlso: auricular vagus nerve stimulation, percutaneous auricular vagus nerve stimulationVIVO 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®. | Device | Standard-of-Care + VIVO 2nd GEN |
| Standard-of-Care Multimodal Pain TherapyThe 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 | Other | Standard-of-Care (SoC), Standard-of-Care + VIVO 2nd GEN |
Primary outcome
Oswestry Disability Index (ODI)
Time frame: Change from baseline to end of treatment (visit V5) at 4 weeks
Questionnaire for assessing functional status and quality-of-life impairment in patients with low back pain or spinal cord disease and injury. The ODI score ranges from 0 - 100%, with higher scores indicating a more severe disability
7 secondary outcomes
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.
Numerical and qualitative pain rating scales
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rudolf Likar, Prim. Univ.-Prof. Dr. MSc. principal investigator
Klinikum Klagenfurt am Wörthersee
Thomas Ettenauer, Dr. principal investigator
Klinikum Klagenfurt am Wörthersee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIVO 2nd GEN and Standard-of-Care Multimodal Pain Therapy in people with Chronic Low Back Pain (CLBP), run by Aurimod GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefan Kampusch, DI (+43 650 36 99 271, s.kampusch@aurimod.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (ODI) (time frame: Change from baseline to end of treatment (visit V5) at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.