Percutaneous ear (auricular) vagus nerve stimulation plus standard rehabilitation for chronic back pain

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 is a prospective, open-label, randomized controlled pilot testing percutaneous auricular vagus nerve stimulation (pVNS) using the VIVO® wearable device combined with standard-of-care inpatient rehabilitation over a 3-week program. Patients with chronic myofascial/musculoskeletal back pain will be randomized to receive pVNS plus rehabilitation or rehabilitation alone. The trial will measure feasibility, safety, pain levels, and functional outcomes using standard instruments such as painDETECT and the Oswestry Disability Index. The goal is to determine whether adding personalized pVNS during physiotherapy produces measurable short-term improvements.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female aged ≥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
* Severity according to "Leistungskategorie 2" of BVAEB classification, which means Barthel Index 35-80, 6-minute walk test 300-480 m OR ergometry 50-80%/0.75-1.25, ICF-Core-Sets grade 3
* Average pain over the last 4 weeks according to painDETECT ≥ 4 and ≤ 9 at baseline
* ODI 20-80 at baseline
* Patient understands the therapy and procedures, agrees to its provisions, and gives written informed consent prior to any procedures

Exclusion Criteria:

* Organic back pain (trauma, fracture, tumor, infection, severe degenerative spine, documented high-grade spinal stenosis, rheumatologic conditions)
* Indication for back surgery
* Radicular pain
* Back surgery within the last 6 months
* New analgesics 2 weeks before baseline (paracetamol, NSAIDs, Metamizol, etc.)
* Opioid analgesic therapy \> WHO II
* Underwent other 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 or strong anti-coagulation medication
* Autonomic disorders
* Advanced stage or poorly controlled diabetes mellitus type I or II
* Poorly controlled high blood pressure
* Major psychiatric comorbidity (at the discretion of the PI)
* 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
* Relevant change in concomitant treatment or medication during the study

Where it's running

• BVAEB Rehazentrum Engelsbad
  Baden, Lower Austria, Austria Recruiting

Study contacts

• Principal investigator: Richard Crevenna, Univ.-Prof. Dr. MBA, MSc, MSc — Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Austria
• Study coordinator: Richard Crevenna, Univ.-Prof. Dr. MBA, MSc, MSc
• Email: richard.crevenna@meduniwien.ac.at
• Phone: +43/1 40400-43330

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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.