Chronic Back PainCURANCT07529392
Percutaneous Auricular Vagus Nerve Stimulation With Conventional Rehabilitation Training in Chronic Back Pain Patients
A study testing Percutaneous auricular vagus nerve stimulation (pVNS) in people with Chronic Back Pain, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Chronic Back Pain
- What is being tested?
- Percutaneous auricular vagus nerve stimulation (pVNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteAustria
- Study dates
- 27 Nov 2025to 15 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Richard Crevenna, Univ.-Prof. Dr. MBA, MSc, MSc contact
Timothy Hasenöhrl, PD Dr. MSc, BSc contact
Austria1 site, 1 recruiting
- Recruiting
BVAEB Rehazentrum Engelsbad
Baden, Lower Austria, 2500
Alexander Fellmann Bauer, Prim. Dr., +43/050405-81090, alexander.fellmann-bauer@bvaeb.at
Peter Machacek, Dr., peter.machacek@bvaeb.at
About this study
Official 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
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:
Read more
- 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
- Being tested
- Percutaneous auricular vagus nerve stimulation (pVNS), Standard of care
- Keywords
- Percutaneous Auricular Vagus Nerve Stimulation, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous auricular vagus nerve stimulation (pVNS)Device
Personalized pain treatment through percutaneous auricular vagus nerve stimulation (pVNS) in addition to standard rehabilitation.
Standard of careOther
Standard of care rehabilitation training, in the course of the in-patient rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to End of Treatment (3 weeks)
Secondary outcomes (6)
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline to End of Treatment (3 weeks) and Follow-Up (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start27 Nov 2025
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Back PainStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Crevenna, Medical University of Vienna
- Investigators
- Richard Crevenna, Univ.-Prof. Dr. MBA, MSc, MSc, Principal investigator, Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529392
- Sponsor's protocol ID
- GS3-EK-3/271-2025
- Acronym
- CURA
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study data are analyzed pseudonymously for the entire population, not at the individual level.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07529392
- Acronym / sponsor ID
- CURA / GS3-EK-3/271-2025
- Conditions
- Chronic Back Pain
- Keywords
- Percutaneous Auricular Vagus Nerve Stimulation, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 27 Nov 2025 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous auricular vagus nerve stimulation combined with standard-of-care rehabilitation | Experimental | Device: Percutaneous auricular vagus nerve stimulation (pVNS), Other: Standard of careIn 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. |
| Standard-of-care rehabilitation | Active comparator | Other: Standard of careThe patients in this group will receive standard treatment and training at the rehabilitation center where the study is taking place. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (25 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous auricular vagus nerve stimulation (pVNS)Personalized pain treatment through percutaneous auricular vagus nerve stimulation (pVNS) in addition to standard rehabilitation. | Device | Percutaneous auricular vagus nerve stimulation combined with standard-of-care rehabilitation |
| Standard of careStandard of care rehabilitation training, in the course of the in-patient rehabilitation | Other | Percutaneous auricular vagus nerve stimulation combined with standard-of-care rehabilitation, Standard-of-care rehabilitation |
Primary outcome
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).
6 secondary outcomes
VIVO® Perception & Usability Questionnaire
Time frame: End of Treatment (3 weeks)
Oswestry Disability Index (ODI)
Time frame: Baseline to follow-up (3 months)
painDETECT
Time frame: Baseline to End of Treatment (3 weeks) and follow-up (3 months)
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Time frame: Baseline to End of Treatment (3 weeks) and follow-up (3 months)
Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
Time frame: Baseline to End of Treatment (3 weeks) and follow-up (3 months)
Socioeconomic Data
Time frame: Baseline to End of Treatment (3 weeks) and Follow-Up (3 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No. The study data are analyzed pseudonymously for the entire population, not at the individual level.
Related trials for Chronic Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
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Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard Crevenna, Univ.-Prof. Dr. MBA, MSc, MSc contact
Timothy Hasenöhrl, PD Dr. MSc, BSc contact
Richard Crevenna, Univ.-Prof. Dr. MBA, MSc, MSc principal investigator
Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous auricular vagus nerve stimulation (pVNS) in people with Chronic Back Pain, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard Crevenna, Univ.-Prof. Dr. MBA, MSc, MSc (+43/1 40400-43330, richard.crevenna@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (ODI) (time frame: Baseline to End of Treatment (3 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.