NCT07628179 SENECA - Smart Therapies for Chronic Pain
| NCT ID | NCT07628179 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aurimod GmbH |
| Condition | Chronic Low Back Pain (CLBP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2026-10-10 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2026-10-10 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
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 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
Contact & Investigator
Rudolf Likar, Prim. Univ.-Prof. Dr. MSc.
PRINCIPAL INVESTIGATOR
Klinikum Klagenfurt am Wörthersee
Frequently Asked Questions
Who can join the NCT07628179 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 65 Years, studying Chronic Low Back Pain (CLBP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07628179 currently recruiting?
Yes, NCT07628179 is actively recruiting participants. Contact the research team at s.kampusch@aurimod.com for enrollment information.
Where is the NCT07628179 trial being conducted?
This trial is being conducted at Klagenfurt, Austria.
Who is sponsoring the NCT07628179 clinical trial?
NCT07628179 is sponsored by Aurimod GmbH. The principal investigator is Rudolf Likar, Prim. Univ.-Prof. Dr. MSc. at Klinikum Klagenfurt am Wörthersee. The trial plans to enroll 44 participants.