Status:
COMPLETED
Personalized Auricular Vagus Nerve Stimulation in Intractable Chronic Low Back Pain
Lead Sponsor:
Aurimod GmbH
Collaborating Sponsors:
Klinikum Klagenfurt am Wörthersee
La Tour Hospital
Conditions:
Chronic Low-back Pain
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2022
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04753528
Start Date
April 13 2021
End Date
October 25 2022
Last Update
February 1 2023
Active Locations (2)
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1
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Carinthia, Austria, 9020
2
Hopital de La Tour
Geneva, Switzerland, 1217