This will be a randomized controlled prospective pilot study: The feasibility and usability of VIVO 2nd GEN therapy + Standard-of-Care (SoC) vs. Standard-of-Care alone will be evaluated. At baseline, after informed consent and evaluation of inclusion and exclusion criteria, evaluation of pain on Numerical and qualitative pain rating scales, quality of life (EQ-5D-5L questionnaire), mental health (HADS questionnaire), and the effect of back pain on function and daily activities (ODI questionnaire) will be performed. After that, all patients will start their multimodal treatment plan. The control group will only receive SoC multimodal therapy training (this includes specifically: physio group therapy, water therapy, strength training, Nordic walking, massages, thermos therapy, lectures and trainings, psychotherapy, local electrotherapy). The treatment group will additionally receive pVNS as add-on therapy. Within this study the next generation device VIVO 2nd GEN will be used within a pVNS proofed indication. The study documentation in both groups will be supported by a digital diary App (VIVO® Pal) and an online dashboard for physicians/therapists (Therapy Management System - TMS), allowing for pseudonymized data entries and management. Patients will remain on treatment for 4 weeks. All patients will be evaluated using questionnaires (Numerical and qualitative pain rating scales, EQ-5D-5L, HADS, ODI) at baseline, weekly during treatment for 4 weeks, by end of treatment and at 4 weeks (optional 3 months and 6 months) follow-up (e.g., via telephone or the App, see below).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
VIVO 2nd GEN is a wearable medical device for personalized pain treatment through percutaneous auricular vagus nerve stimulation (pVNS). It is the next-generation device of the CE-marked pVNS device VIVO®, which is approved for chronic pain indications including chronic back pain. It is a battery-operated electrical stimulation device, to be placed behind the ear on the neck, and connects to three needle electrodes, which are placed in vagally innervated regions of the auricle. It emits electrical signals with a defined set of parameters, i.e., fixed pulse width, fixed frequency, fixed bursted stimulation, but with adjustable amplitude and fixed duty cycle. It is smaller and lighter than VIVO® and the stimulator is re-usable with single-use battery pack and needle electrodes. Stimulation parameters are equal to VIVO®.
The Standard-of-Care multimodal pain therapy includes specifically: physio group therapy, water therapy, strength training, Nordic walking, massages, thermos therapy, lectures and trainings, psychotherapy, local electrotherapy, medical evaluation
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Carinthia, Austria
Oswestry Disability Index (ODI)
Questionnaire for assessing functional status and quality-of-life impairment in patients with low back pain or spinal cord disease and injury. The ODI score ranges from 0 - 100%, with higher scores indicating a more severe disability
Time frame: Change from baseline to end of treatment (visit V5) at 4 weeks
Questionnaire: Patient evaluation of device perception and usability
Patient evaluation of perception and usability of the VIVO 2nd GEN investigational medical device and the VIVO® Pal smartphone app using questionnaires. Patients rate agreement with statements on ease of use, tolerability, wearing comfort of the investigational medical device (e.g. "The device was easy to use", "I quickly got used to the device") on scales from 1 (does not apply at all) to 5 (fully applies). Patients rate interference of the device with everyday activities separately for each of 9 activities as "unchanged", "more difficult" and "much more difficult". Patients rate agreement with statements on ease of use, functionality and optic impression of the accompanying smartphone app on scales from 1 (does not apply at all) to 5 (fully applies).
Time frame: Perception and usability of the VIVO 2nd GEN device is assessed at end of treatment (EoT) at 4 weeks. Perception and usability of the VIVO® Pal smartphone app is assessed at EoT at 4 weeks and at follow ups 4 weeks, 3 months and 6 months after EoT.
Questionnaire: Physicians' evaluation of device perception and usability
Physician's evaluation of satisfaction with therapy and usability of VIVO 2nd GEN device, VIVO® Pal (smartphone app) and therapy management system (web dashboard) using questionnaires. Physicians rate agreement with statements application and adjustment of the device (e.g. "After training, it was easy to correctly apply the device") on scales from 1 (does not apply at all) to 5 (fully applies). Physicians rate agreement with statements on ease of use, functionality and optic impression of the accompanying smartphone app and web dashboard on scales from 1 (does not apply at all) to 5 (fully applies).
Time frame: Perception and usability of the VIVO 2nd GEN device assessed at end of treatment (EoT) at 4 weeks. Perception and usability of the VIVO® Pal smartphone app and web dashboard at EoT at 4 weeks and at follow ups 4 weeks, 3 months and 6 months after EoT.
Health-related quality of life questionnaire (EQ-5D-5L)
Health-related quality of life is reported by patients using the EuroQOL 5 dimensions, 5 levels questionnaire. The 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. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. On the EQ VAS, patients rate their health on a vertical visual analogue scale where endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Time frame: Change from baseline to end-of-treatment at 4 weeks and to follow up at 4 weeks, 3 months, and 6 months after end-of-treatment.
Hospital Anxiety and Depression Scale (HADS)
The HADS serves as a self-report instrument to assess anxiety and depression, particularly in medical settings. It comprises 14 items, evenly split between two subscales: seven items assessing anxiety and seven evaluating depression. Each item focuses on emotional symptoms, such as feeling tense or cheerful, using a 4-point Likert scale ranging from 0 (not at all) to 3 (most of the time). Total scores range from 0 to 42, with higher scores indicating greater symptom severity.
Time frame: Change from baseline to end-of-treatment at 4 weeks and to follow up at 4 weeks, 3 months, and 6 months after end-of-treatment.
Numerical and qualitative pain rating scales
Numerical and qualitative pain rating scales are used to rate pain intensity and pain quality. Pain intensity is rated at the current moment, as well as worst pain and average pain during the previous four weeks on numerical rating scales (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain). Pain quality is evaluated by selecting between four categories.
Time frame: Change from baseline to end-of-treatment at 4 weeks and to follow up at 4 weeks, 3 months, and 6 months after end-of-treatment.
Smartphone-App Patient-Reported Outcomes
Within the VIVO Pal smartphone applications, patients are encouraged to enter additional patient reported outcomes on overall wellbeing, sleep, mobility, and pain. These items are rated on 5-point-scales ranging from "very bad" to "very good". Patients can also enter their medication throughout the study (in addition to concomitant medication querying by the investigator at in-patient and telemedical visit).
Time frame: Throughout the clinical investigation; from baseline to follow up (up to 6 months after end of treatment)
Socioeconomic Data Questionnaire
Patients report socioeconomic data like work status (working, full time/part time, sick leave, retired, etc.)
Time frame: Change from baseline to end-of-treatment at 4 weeks and to follow up at 4 weeks, 3 months, and 6 months after end-of-treatment.
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