Chronic Low Back Pain study: VIVO
Official title SENECA - Smart Therapies for Chronic Pain
ClinicalTrials.gov ID: NCT07628179
What this study is testing
- What it's testing
- This will be a controlled study: The feasibility and usability of VIVO 2nd GEN therapy + Standard-of-Care (SoC) vs.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 65
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Klagenfurt, Carinthia, Austria
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Klagenfurt, Carinthia, Austria. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.