Percutaneous Auricular Vagus Nerve Stimulation With Conventional Rehabilitation Training in Chronic Back Pain Patients (CURA)

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

The therapeutic action of aVNS in pain treatment is based on the masking of pain by the electrical stimulation pulses, the activation of inhibiting pain control systems, and the release of neurotransmitters, such as endorphins. Pairing VNS stimulation with exercise and physiotherapy has yielded beneficial results in stroke patients as well as in smaller studies with back pain patients, already in short periods of time (2-4 weeks).

The current study is intended to evaluate the performance of percutaneous auricular Vagus Nerve Stimulation (pVNS) in combination with Standard-of-Care (SoC) in a 3-week in-patient rehabilitation setting, in patients with chronic musculoskeletal/myofascial back pain. This will be a prospective, open, randomized, controlled pilot study to evaluate pVNS using the VIVO® wearable medical device for personalized pain treatment, in terms of feasibility, efficacy, and safety in combination with rehabilitation training. Patients will be randomized into one of the following treatment groups:

• Group A: VIVO® (pVNS) + SoC (treatment group)
• Group B: SoC (control/comparator group) Patients will remain on treatment for 3 weeks. This is comparable to other studies performed earlier, which showed safe and effective use of pVNS in chronic pain patients. The additional follow-up period of 3 weeks (optional 3 months and 6 months) allows to evaluate sustainable effects of treatment and late time effects, as previously shown in other studies.

Patients in the treatment group (VIVO® + SoC) will receive personalized aVNS therapy in combination with SoC. Personalization of VIVO® treatment is performed based on the individual perception level of the stimulation at the ear with regards to the stimulation amplitude (in Group A). Amplitude is adjusted (range 0-5 V) to reach a distinct but comfortable tingling sensation to reach activation of Aβ-fibers of the auricular vagus nerve but not Aδ-fibers producing a sensation of pain. Not only the Investigator is able to adjust the amplitude at the trial visit (via VIVO® Pen) but also the patient is able to adjust the amplitude according to his/her perception.

Patients will be randomized in this pilot study to receive either aVNS with the VIVO® system in addition to SoC vs. SoC alone as comparator group. Estimates of performance endpoints will thus be contrasted between aVNS and an established treatment option in this indication and controlled for regression to the mean and other forms of sampling bias.

All concomitant medication and therapies will be thoroughly documented and taken into account in the final analysis.

Study Overview

• Status: Recruiting
• Conditions: Chronic Back Pain
• Intervention / Treatment: Device: Percutaneous auricular vagus nerve stimulation (pVNS); Other: Standard of care

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Richard Crevenna, Univ.-Prof. Dr. MBA, MSc, MSc; Phone Number: +43/1 40400-43330; Email: richard.crevenna@meduniwien.ac.at
• Study Contact Backup: Name: Timothy Hasenöhrl, PD Dr. MSc, BSc; Email: timothy.hasenoehrl@meduniwien.ac.at

Study Locations

• Austria
  • Lower Austria
    • Baden, Lower Austria, Austria, 2500
      • Recruiting
      • BVAEB Rehazentrum Engelsbad
      • Contact: Alexander Fellmann Bauer, Prim. Dr.; Phone Number: +43/050405-81090; Email: alexander.fellmann-bauer@bvaeb.at
      • Contact: Peter Machacek, Dr.; Email: peter.machacek@bvaeb.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Percutaneous auricular vagus nerve stimulation combined with standard-of-care rehabilitation; In addition to standard treatment and training at the rehabilitation center where the study is taking place, patients in the experimental group will receive a portable medical device for personalized pain management via percutaneous auricular vagus nerve stimulation (pVNS) during their rehabilitation stay.	Device: Percutaneous auricular vagus nerve stimulation (pVNS); Personalized pain treatment through percutaneous auricular vagus nerve stimulation (pVNS) in addition to standard rehabilitation.; Other: Standard of care; Standard of care rehabilitation training, in the course of the in-patient rehabilitation
Active Comparator: Standard-of-care rehabilitation; The patients in this group will receive standard treatment and training at the rehabilitation center where the study is taking place.	Other: Standard of care; Standard of care rehabilitation training, in the course of the in-patient rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI)	The Oswestry Disability Index (ODI) is a self-administered, 10-item questionnaire used to measure permanent functional disability in patients with low back pain. It assesses functional limitations in daily activities like pain intensity, personal hygiene, lifting, walking, sleeping, and social life, scoring from 0 (minimum, no pain-related disability) to 100 (maximum, highest possible pain-related disability).	Baseline to End of Treatment (3 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VIVO® Perception & Usability Questionnaire	The VIVO® Perception & Usability Questionnare is a qualitative questionnaire to evaluate user acceptance, where only some questions include numerical (quantitative) ratings from 1-5 to assess usability, with 1 being the least satisfying user experience and 5 the best user experience. Each question will be analyzed separately.	End of Treatment (3 weeks)
Oswestry Disability Index (ODI)	The Oswestry Disability Index (ODI) is a self-administered, 10-item questionnaire used to measure permanent functional disability in patients with low back pain. It assesses functional limitations in daily activities like pain intensity, personal hygiene, lifting, walking, sleeping, and social life, scoring from 0 (minimum, no pain-related disability) to 100 (maximum, highest possible pain-related disability).	Baseline to follow-up (3 months)
painDETECT	The painDETECT questionnaire (PD-Q) is a screening tool used to identify neuropathic pain components, with a total score ranging from to 38. A score of indicates a >90% likelihood of neuropathic pain, 13-18 suggests a possible or transitional neuropathic component, and suggests a lower likelihood, often indicating nociceptive pain.	Baseline to End of Treatment (3 weeks) and follow-up (3 months)
EuroQol 5-Dimension 5-Level (EQ-5D-5L)	The EuroQol 5-Dimension 5-Level (EQ-5D-5L) consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems (1 to 5). The results for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The higher the score the worse the outcome. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of subjective health perception. the higher the VAS the better the patients subjective health rating (0-100).	Baseline to End of Treatment (3 weeks) and follow-up (3 months)
Depression, Anxiety and Stress Scale - 21 Items (DASS-21)	The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Final scores are between 0-42, the higher the scores the more severe are the emotional states.	Baseline to End of Treatment (3 weeks) and follow-up (3 months)
Socioeconomic Data	Qualitative questionnaire to evaluate change in weight, familial status, workability, mobility (physical exercise), smoking, alcohol consumption and caffeine intake.	Baseline to End of Treatment (3 weeks) and Follow-Up (3 months)

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Richard Crevenna, Univ.-Prof. Dr. MBA, MSc, MSc, Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Austria

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): March 15, 2027

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; Percutaneous Auricular Vagus Nerve Stimulation
• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: GS3-EK-3/271-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study data are analyzed pseudonymously for the entire population, not at the individual level.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No