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).
Who can participate
Age range
30 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as 'not yet recruiting' — can you help me find out when it's expected to open and whether it would be worth waiting for it versus starting another treatment now?
2The trial is measuring success using something called the Oswestry Disability Index, which tracks how much back pain limits daily activities — based on how much my daily life is currently affected, do you think I'd be a good candidate to discuss with the research team?
3Since this trial is listed as Phase NA, which sometimes means it's testing a digital or behavioral approach rather than a drug, can you tell me more about what 'smart therapies' actually involves and whether there are any known risks I should be aware of?
4Are there standard treatments for chronic low back pain — like physical therapy, medication, or injections — that I should try first before considering enrolling in a study like this one?
5Given that this trial hasn't started recruiting yet, is there anything I can do now, like getting on a waitlist or having my medical records reviewed, so I'm prepared if I do decide to pursue it when it opens?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Oswestry Disability Index (ODI)
Timeframe: Change from baseline to end of treatment (visit V5) at 4 weeks