VIVO 2nd GEN add-on for chronic low back pain with multimodal therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized pilot study compares standard multimodal pain therapy alone versus standard therapy plus the VIVO 2nd GEN auricular vagus nerve stimulation in adults with chronic low back pain. Participants undergo baseline assessments of pain, quality of life, mood, and function, then receive their assigned treatment plan for a defined period. Outcomes will inform feasibility and usability of the device and its potential to improve pain, daily functioning, and quality of life when used alongside conventional care. The study uses a multimodal approach including physical therapy, aquatic therapy, exercise, and psychosocial support, with the device added for the treatment group. The next-generation device is used as an add-on therapy in this evaluation.

Why it matters

Who can join: the full rules

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 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

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

Where it's running

• Klinikum Klagenfurt am Wörthersee
  Klagenfurt, Carinthia, Austria Recruiting

Study contacts

• Principal investigator: Rudolf Likar, Prim. Univ.-Prof. Dr. MSc. — Klinikum Klagenfurt am Wörthersee
• Study coordinator: Stefan Kampusch, DI
• Email: s.kampusch@aurimod.com
• Phone: +43 650 36 99 271

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.