Chronic Low-back PainAuriModNCT04753528
Personalized Auricular Vagus Nerve Stimulation in Intractable Chronic Low Back Pain
A study testing AuriMod CT01_A, AuriMod CT01_B and AuriMod CT01_C in people with Chronic Low-back Pain, run by Aurimod GmbH at 2 sites in 2 countries.
Trial summary
One in five people in the general adult population suffer from chronic pain, a figure that is higher than heart disease, cancer, and diabetes combined. A majority of these patients is suffering from chronic back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- AuriMod CT01_A, AuriMod CT01_B and AuriMod CT01_C
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Apr 2021to 25 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 to 65 years at screening
- Patient has an understanding of the study and its procedures, agrees to its provisions, and gives written informed consent prior to any study-related procedures
- Chronic back pain with or without leg pain (CBLP) persisting for at least 3 months
- A minimum of 70 (out of 180) points on the Computer User Self-Efficacy Scale at the screening visit
- Patient is constant with respect to pain treatment during the screening phase
- A daily average VAS >= 4 on at least half of the days in the screening phase
- Compliance with the daily status reporting requirements as demonstrated by having valid required data entries for all days. It is acceptable if data of one day is missing in the screening phase
Who cannot join
- Patients with age under 18
- Hemophilia
- Infection, eczema, or psoriasis at application site
- Numbed and desensitized skin at the application site
- Florid malignant diseases
- Mental and physical impairments that represent a source of risk for handling the device
Show all 20Show fewer
- The presence of a cardiac pacemaker, defibrillator, cochlear implant, or other active implantable device
- Vagal hypersensitivity
- Indication for back surgery
- High-grade spinal stenosis
- Patients with other active implants
- Patients with autonomic disorders
- Patients with diabetes type I or II
- Patients taking Beta-Blockers
- Patients taking drugs carrying the potential risk of arrhythmia (tricyclic medications, Alzheimer drugs, etc.)
- Clinically significant hip or knee arthritis
- Allergy against rescue medication used during the study
- History of Vagus Nerve Stimulation
- Pregnant or nursing female patients
- Patients with arrhythmia, bradycardia, other rhythm disorders or any other clinically significant cardiac anomalies detected during ECG at screening
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Personalized Auricular Vagus Nerve Stimulation in Patients With Intractable Chronic Low Back Pain: A Randomized Controlled Pilot Study
One in five people in the general adult population suffer from chronic pain, a figure that is higher than heart disease, cancer, and diabetes combined. A majority of these patients is suffering from chronic back pain. Conventional treatment options offer only a partial response, with many people continuing to suffer severe chronic pain, despite receiving several treatments.
Non-pharmacological treatments by neuromodulation represent a promising treatment modality for these patients. For instance, spinal cord stimulation blocks pain signals travelling to the brain, but requires implantation near the spine with significant clinical risks. Vagus nerve stimulation (VNS) is another neuromodulation modality proposed to alleviate chronic pain. Conventional VNS devices are implanted under the skin on the chest and the electrodes are wired to the left vagus nerve in the neck. However, aside from implantation risks, VNS is often associated with side effects such as swallowing difficulties, due to unwanted stimulation of motoric vagus nerve branches in the neck.
Read more
Percutaneous auricular VNS (pVNS) is an emerging technology for stimulation of the auricular branch of the vagus nerve in the pinna of the ear. Specific electrical impulses are applied via three miniature needle electrodes located in the auricle near sensory vagus nerve fibers. Scientific data show that pVNS modulates brain circuits involved in autonomic control and pain processing. pVNS has shown positive effects in chronic low-back pain patients, in a sustainable way with a low side-effect profile. However, the optimal settings of stimulation with regards to personalization remain to be elucidated.
The present prospective, open, randomized, controlled pilot study aims at evaluating the performance of pVNS treatment, using a small wearable stimulation device (AuriMod CT01), comparing personalized and non-personalized stimulation paradigms in patients with chronic low-back pain. Patients will be randomized in one of the following treatment groups (1) Group A: Stimulation with personalized stimulation parameters and amplitude, (2) Group B: Stimulation with personalized stimulation amplitude, (3) Group C: Stimulation without personalization (comparator group).
Patients will be treated for 8 weeks. Patients will receive standardized pain medication including rescue medication in parallel. An additional follow-up period of 12 weeks allows to evaluate sustainable and late-time effects of treatment. Patients will use a therapy management system to monitor outcome.
- Conditions
- Chronic Low-back Pain
- Being tested
- AuriMod CT01_A, AuriMod CT01_B, AuriMod CT01_C
- Keywords
- Vagus Nerve Stimulation, Personalization, Therapy Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AuriMod CT01_ADevice
AuriMod CT01 is a wearable medical device for personalised pain treatment through auricular vagus nerve stimulation. AuriMod CT01 is a battery-operated electrical stimulation device, to be placed behind the ear on the neck. AuriMod CT01 connects to three needle electrodes, which are placed in vagally innervated regions of the auricle. It emits electrical signals with a personalized set of stimulation parameters and adjustable amplitude.
AuriMod CT01_BDevice
AuriMod CT01 with a fixed set of stimulation parameters and adjustable stimulation amplitude.
AuriMod CT01_CDevice
AuriMod CT01 with a fixed set of stimulation parameters and amplitude.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Personalized stimulation parameters and amplitude Receives: Device: AuriMod CT01_A |
| Group B | Experimental | Personalized stimulation amplitude Receives: Device: AuriMod CT01_B |
| Group C | Active comparator | Non-personalized stimulation Receives: Device: AuriMod CT01_C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average VAS
Change from baseline to End of Treatment (EoT) in average Visual Analogue Scale (VAS; scale 0-10, steps 0.1, 0...no pain, 10...worst pain) during the last 24 hours before the visit
Measured: 8 weeks
Secondary outcomes (17)
Max/Min VAS
Change from baseline to EoT in max/min VAS (scale 0-10, steps 0.1, 0...no pain, 10...worst pain)
Measured: 8 weeks
Average/Max/Min VAS (follow-up; scale 0-10, steps 0.1, 0...no pain, 10...worst pain)
Change from baseline to End of Follow-Up in average/max/min VAS
Measured: 20 weeks
Normalized average/max/min VAS (scale 0-10, steps 0.1, 0...no pain, 10...worst pain)
Baseline-adjusted area under the max/min/average VAS from baseline to EoT
Measured: 8 weeks
VAS (follow-up; scale 0-10, steps 0.1, 0...no pain, 10...worst pain)
VAS during follow-up
Measured: 12 weeks
Medication use
Pain and rescue medication consumption during treatment and follow-up phase
Measured: 20 weeks
Heart Rate
Change in heart rate over therapy and follow-up
Measured: 20 weeks
Heart Rate Variability
Change in heart rate variability over therapy and follow-up
Measured: 20 weeks
Blood Pressure
Change in blood pressure over therapy and follow-up
Measured: 20 weeks
Patient motility
Change in daily step count over therapy and follow-up
Measured: 20 weeks
painDETECT
painDETECT questionnaire over treatment and follow-up
Measured: 20 weeks
EQ-5D-5L
EQ-5D-5L questionnaire over treatment and follow-up
Measured: 20 weeks
HADS
Hospital Anxiety and Depression Score (HADS) over treatment and follow-up
Measured: 20 weeks
Sleep quality
Sleep quality (5-item questionnaire) over treatment and follow-up
Measured: 20 weeks
Wellbeing
Subjective wellbeing (on a 3-point ordinal scale: good, medium, bad)
Measured: 20 weeks
Perception Scale
AuriMod CT01 Perception Scale evaluating the quality of stimulation perception in a 10-item questionnaire at EoT
Measured: 8 weeks
Usability Scale
AuriMod CT01 Usability scoring using the System Usability Scale (10-item scale from 10-50, 10...worst usability, 50...best usability) at EoT
Measured: 8 weeks
Socioeconomic data
Socioeconomic data change over treatment and follow-up
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start13 Apr 2021
- Primary completion25 Oct 2022
- Study completion25 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurimod GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Klinikum Klagenfurt am Wörthersee, La Tour Hospital
- Responsible party
- Sponsor
- Investigators
- Rudolf Likar, Univ.-Prof. Dr., Principal investigator, Abteilung für Anästhesiologie und Intensivmedizin, Klinikum Klagenfurt am Wörthersee, Feschingstrasse 11, 9020 Klagenfurt am Wörthersee, AustriaChristophe Perruchoud, PD Dr., Principal investigator, Clinique de la Douleur, Hopital de La Tour, Avenue Jacob-Daniel Maillard 3, 1217 Meyrin, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753528
- Sponsor's protocol ID
- AT-MF-000000433-CIV-001
- Acronym
- AuriMod
- Status last verified
- Jan 2023
- First submitted
- 27 Jan 2021
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Auricular Vagus Nerve Stimulation in Patients With Intractable Chronic Low Back Pain: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT04753528
- Acronym / sponsor ID
- AuriMod / AT-MF-000000433-CIV-001
- Conditions
- Chronic Low-back Pain
- Keywords
- Vagus Nerve Stimulation, Personalization, Therapy Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Aurimod GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Klinikum Klagenfurt am Wörthersee, La Tour Hospital
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 15 Feb 2021 (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.
One in five people in the general adult population suffer from chronic pain, a figure that is higher than heart disease, cancer, and diabetes combined. A majority of these patients is suffering from chronic back pain. Conventional treatment options offer only a partial response, with many people continuing to suffer severe chronic pain, despite receiving several treatments.
Non-pharmacological treatments by neuromodulation represent a promising treatment modality for these patients. For instance, spinal cord stimulation blocks pain signals travelling to the brain, but requires implantation near the spine with significant clinical risks. Vagus nerve stimulation (VNS) is another neuromodulation modality proposed to alleviate chronic pain. Conventional VNS devices are implanted under the skin on the chest and the electrodes are wired to the left vagus nerve in the neck. However, aside from implantation risks, VNS is often associated with side effects such as swallowing difficulties, due to unwanted stimulation of motoric vagus nerve branches in the neck.
Percutaneous auricular VNS (pVNS) is an emerging technology for stimulation of the auricular branch of the vagus nerve in the pinna of the ear. Specific electrical impulses are applied via three miniature needle electrodes located in the auricle near sensory vagus nerve fibers. Scientific data show that pVNS modulates brain circuits involved in autonomic control and pain processing. pVNS has shown positive effects in chronic low-back pain patients, in a sustainable way with a low side-effect profile. However, the optimal settings of stimulation with regards to personalization remain to be elucidated.
The present prospective, open, randomized, controlled pilot study aims at evaluating the performance of pVNS treatment, using a small wearable stimulation device (AuriMod CT01), comparing personalized and non-personalized stimulation paradigms in patients with chronic low-back pain. Patients will be randomized in one of the following treatment groups (1) Group A: Stimulation with personalized stimulation parameters and amplitude, (2) Group B: Stimulation with personalized stimulation amplitude, (3) Group C: Stimulation without personalization (comparator group).
Patients will be treated for 8 weeks. Patients will receive standardized pain medication including rescue medication in parallel. An additional follow-up period of 12 weeks allows to evaluate sustainable and late-time effects of treatment. Patients will use a therapy management system to monitor outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: AuriMod CT01_APersonalized stimulation parameters and amplitude |
| Group B | Experimental | Device: AuriMod CT01_BPersonalized stimulation amplitude |
| Group C | Active comparator | Device: AuriMod CT01_CNon-personalized stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female aged 18 to 65 years at screening
- Patient has an understanding of the study and its procedures, agrees to its provisions, and gives written informed consent prior to any study-related procedures
- Chronic back pain with or without leg pain (CBLP) persisting for at least 3 months
- A minimum of 70 (out of 180) points on the Computer User Self-Efficacy Scale at the screening visit
- Patient is constant with respect to pain treatment during the screening phase
Key exclusion criteria (20 listed)
- Patients with age under 18
- Hemophilia
- Infection, eczema, or psoriasis at application site
- Numbed and desensitized skin at the application site
- Florid malignant diseases
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 |
|---|---|---|
| AuriMod CT01_AAuriMod CT01 is a wearable medical device for personalised pain treatment through auricular vagus nerve stimulation. AuriMod CT01 is a battery-operated electrical stimulation device, to be placed behind the ear on the neck. AuriMod CT01 connects to three needle electrodes, which are placed in vagally innervated regions of the auricle. It emits electrical signals with a personalized set of stimulation parameters and adjustable amplitude. | Device | Group A |
| AuriMod CT01_BAuriMod CT01 with a fixed set of stimulation parameters and adjustable stimulation amplitude. | Device | Group B |
| AuriMod CT01_CAuriMod CT01 with a fixed set of stimulation parameters and amplitude. | Device | Group C |
Primary outcome
Average VAS
Time frame: 8 weeks
Change from baseline to End of Treatment (EoT) in average Visual Analogue Scale (VAS; scale 0-10, steps 0.1, 0...no pain, 10...worst pain) during the last 24 hours before the visit
17 secondary outcomes
Max/Min VAS
Time frame: 8 weeks
Average/Max/Min VAS (follow-up; scale 0-10, steps 0.1, 0...no pain, 10...worst pain)
Time frame: 20 weeks
Normalized average/max/min VAS (scale 0-10, steps 0.1, 0...no pain, 10...worst pain)
Time frame: 8 weeks
VAS (follow-up; scale 0-10, steps 0.1, 0...no pain, 10...worst pain)
Time frame: 12 weeks
Medication use
Time frame: 20 weeks
Heart Rate
Time frame: 20 weeks
Heart Rate Variability
Time frame: 20 weeks
Blood Pressure
Time frame: 20 weeks
Patient motility
Time frame: 20 weeks
painDETECT
Time frame: 20 weeks
EQ-5D-5L
Time frame: 20 weeks
HADS
Time frame: 20 weeks
Sleep quality
Time frame: 20 weeks
Wellbeing
Time frame: 20 weeks
Perception Scale
Time frame: 8 weeks
Usability Scale
Time frame: 8 weeks
Socioeconomic data
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Rudolf Likar, Univ.-Prof. Dr. principal investigator
Abteilung für Anästhesiologie und Intensivmedizin, Klinikum Klagenfurt am Wörthersee, Feschingstrasse 11, 9020 Klagenfurt am Wörthersee, Austria
Christophe Perruchoud, PD Dr. principal investigator
Clinique de la Douleur, Hopital de La Tour, Avenue Jacob-Daniel Maillard 3, 1217 Meyrin, Switzerland
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AuriMod CT01_A, AuriMod CT01_B and AuriMod CT01_C in people with Chronic Low-back Pain, run by Aurimod GmbH at 2 sites in 2 countries.
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 7 inclusion and 20 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: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average VAS (time frame: 8 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 1 Feb 2023.