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NCT Number: NCT07529392

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

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.

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Key information

Conditions

Chronic Back Pain

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BVAEB Rehazentrum Engelsbad

Baden, Lower Austria, 2500, Austria

Location status: Recruiting

Location contact

Alexander Fellmann Bauer, Prim. Dr.

CONTACT

[email protected]

+43/050405-81090

Peter Machacek, Dr.

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous auricular vagus nerve stimulation (pVNS)

Device

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

Standard of care

Other

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

Primary outcomes

  1. Oswestry Disability Index (ODI)

    Time frame: Baseline to End of Treatment (3 weeks)

    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).

Secondary outcomes

  1. VIVO® Perception & Usability Questionnaire

    Time frame: End of Treatment (3 weeks)

    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.

  2. Oswestry Disability Index (ODI)

    Time frame: Baseline to follow-up (3 months)

    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).

  3. painDETECT

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

    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.

  4. EuroQol 5-Dimension 5-Level (EQ-5D-5L)

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

    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).

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

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

    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.

  6. Socioeconomic Data

    Time frame: Baseline to End of Treatment (3 weeks) and Follow-Up (3 months)

    Qualitative questionnaire to evaluate change in weight, familial status, workability, mobility (physical exercise), smoking, alcohol consumption and caffeine intake.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+43/1 40400-43330

Timothy Hasenöhrl, PD Dr. MSc, BSc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Acronym: CURA

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 14, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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