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

NCT07529392 | Recruiting

• 1 other identifier: GS3-EK-3/271-2025
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Back Pain

Keywords

Percutaneous Auricular Vagus Nerve Stimulation; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• VIVO® Perception & Usability Questionnaire

  End of Treatment (3 weeks)

• Oswestry Disability Index (ODI)

  Baseline to follow-up (3 months)

• painDETECT

  Baseline to End of Treatment (3 weeks) and follow-up (3 months)

• EuroQol 5-Dimension 5-Level (EQ-5D-5L)

  Baseline to End of Treatment (3 weeks) and follow-up (3 months)

• Depression, Anxiety and Stress Scale - 21 Items (DASS-21)

  Baseline to End of Treatment (3 weeks) and follow-up (3 months)

Study Arms (2)

Percutaneous auricular vagus nerve stimulation combined with standard-of-care rehabilitation

EXPERIMENTAL

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); Other: Standard of care

Standard-of-care rehabilitation

ACTIVE COMPARATOR

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

Interventions

Percutaneous auricular vagus nerve stimulation (pVNS) DEVICE

Personalized pain treatment through percutaneous auricular vagus nerve stimulation (pVNS) in addition to standard rehabilitation.

Percutaneous auricular vagus nerve stimulation combined with standard-of-care rehabilitation

Standard of care OTHER

Standard of care rehabilitation training, in the course of the in-patient rehabilitation

Percutaneous auricular vagus nerve stimulation combined with standard-of-care rehabilitation; Standard-of-care rehabilitation

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

BVAEB Rehazentrum Engelsbad

Baden, Lower Austria, 2500, Austria

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Richard Crevenna, Univ.-Prof. Dr. MBA, MSc, MSc

  Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Austria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Crevenna, Univ.-Prof. Dr. MBA, MSc, MSc

CONTACT

+43/1 40400-43330; richard.crevenna@meduniwien.ac.at

Timothy Hasenöhrl, PD Dr. MSc, BSc

CONTACT

timothy.hasenoehrl@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Physical Medicine, Rehabilitation and Occupational Medicine

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 14, 2026
• Study Start: November 27, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): March 15, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)