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NCT Number: NCT04753528

Personalized Auricular Vagus Nerve Stimulation in Intractable Chronic Low Back Pain

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.

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Key information

Conditions

Chronic Low-back Pain

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Klagenfurt am Wörthersee, Klagenfurt, Carinthia, Austria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

AuriMod CT01_A

Device

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_B

Device

AuriMod CT01 with a fixed set of stimulation parameters and adjustable stimulation amplitude.

AuriMod CT01_C

Device

AuriMod CT01 with a fixed set of stimulation parameters and amplitude.

Primary outcomes

  1. 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

Secondary outcomes

  1. Max/Min VAS

    Time frame: 8 weeks

    Change from baseline to EoT in max/min VAS (scale 0-10, steps 0.1, 0...no pain, 10...worst pain)

  2. Average/Max/Min VAS (follow-up; scale 0-10, steps 0.1, 0...no pain, 10...worst pain)

    Time frame: 20 weeks

    Change from baseline to End of Follow-Up in average/max/min VAS

  3. Normalized average/max/min VAS (scale 0-10, steps 0.1, 0...no pain, 10...worst pain)

    Time frame: 8 weeks

    Baseline-adjusted area under the max/min/average VAS from baseline to EoT

  4. VAS (follow-up; scale 0-10, steps 0.1, 0...no pain, 10...worst pain)

    Time frame: 12 weeks

    VAS during follow-up

  5. Medication use

    Time frame: 20 weeks

    Pain and rescue medication consumption during treatment and follow-up phase

  6. Heart Rate

    Time frame: 20 weeks

    Change in heart rate over therapy and follow-up

  7. Heart Rate Variability

    Time frame: 20 weeks

    Change in heart rate variability over therapy and follow-up

  8. Blood Pressure

    Time frame: 20 weeks

    Change in blood pressure over therapy and follow-up

  9. Patient motility

    Time frame: 20 weeks

    Change in daily step count over therapy and follow-up

  10. painDETECT

    Time frame: 20 weeks

    painDETECT questionnaire over treatment and follow-up

  11. EQ-5D-5L

    Time frame: 20 weeks

    EQ-5D-5L questionnaire over treatment and follow-up

  12. HADS

    Time frame: 20 weeks

    Hospital Anxiety and Depression Score (HADS) over treatment and follow-up

  13. Sleep quality

    Time frame: 20 weeks

    Sleep quality (5-item questionnaire) over treatment and follow-up

  14. Wellbeing

    Time frame: 20 weeks

    Subjective wellbeing (on a 3-point ordinal scale: good, medium, bad)

  15. Perception Scale

    Time frame: 8 weeks

    AuriMod CT01 Perception Scale evaluating the quality of stimulation perception in a 10-item questionnaire at EoT

  16. Usability Scale

    Time frame: 8 weeks

    AuriMod CT01 Usability scoring using the System Usability Scale (10-item scale from 10-50, 10...worst usability, 50...best usability) at EoT

  17. Socioeconomic data

    Time frame: 20 weeks

    Socioeconomic data change over treatment and follow-up

Other outcomes

  1. Safety Outcome 1

    Time frame: 8 weeks

    Incidence of Adverse Events (AEs) and Device Deficiencies (DDs) observed until EoT

  2. Safety Outcome 2

    Time frame: 20 weeks

    Incidence of Serious Adverse Events (SAEs) and related AEs observed until end of follow-up

Sponsors and collaborators

Lead sponsor

Aurimod GmbH

Industry

Collaborators

  • Klinikum Klagenfurt am Wörthersee
  • La Tour Hospital

Registry information

Official study title

Personalized Auricular Vagus Nerve Stimulation in Patients With Intractable Chronic Low Back Pain: A Randomized Controlled Pilot Study

Acronym: AuriMod

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2021
Registry last updated
Feb 1, 2023

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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