Percutaneous ear (auricular) vagus nerve stimulation plus standard rehabilitation for chronic back pain
Efficacy of Percutaneous Auricular Vagus Nerve Stimulation Combined With Conventional Rehabilitation Training to Improve Functional Outcome in Chronic Back Pain Patients (CURA): A Randomized Controlled Pilot Study
NA · Medical University of Vienna · NCT07529392
This will try adding tiny electrical stimulation to the outer ear (pVNS) alongside standard rehabilitation to see if adults with chronic back pain have less pain and better function.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | All |
| Sponsor | Medical University of Vienna (other) |
| Locations | 1 site (Baden, Lower Austria) |
| Trial ID | NCT07529392 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 30–65 with chronic myofascial/musculoskeletal back pain for more than 6 months who meet the study pain and function thresholds and are eligible for inpatient rehabilitation are ideal candidates.
Not a fit: Patients with organic or radicular causes of back pain, recent back surgery, indications for surgical treatment, or other excluded conditions are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, adding pVNS to rehabilitation could reduce pain and improve function during and after a 3-week inpatient program.
How similar studies have performed: Small studies and programs combining VNS with exercise—including work in stroke patients and limited back pain cohorts—have reported short-term benefits, but robust larger randomized data are lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Baden, Lower Austria
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Back Pain, Percutaneous Auricular Vagus Nerve Stimulation, Rehabilitation