Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
NCT ID:
NCT04753528
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04753528
Study Brief:
Protocol Section:
NCT04753528