SENECA - Smart Therapies for Chronic Pain (SENECA)

实验性的：Standard-of-Care + VIVO 2nd GEN

Standard-of-Care 4-week multimodal pain therapy for chronic pain patients (this includes specifically: physio group therapy, water therapy, strength training, Nordic walking, massages, thermos therapy, lectures and trainings, psychotherapy, local electrotherapy) will be combined with the VIVO 2nd GEN wearable medical device for personalized pain treatment through percutaneous auricular vagus nerve stimulation (paVNS).

设备：VIVO 2nd GEN

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®.

其他名称：

• 耳部迷走神经刺激
• percutaneous auricular vagus nerve stimulation

其他：Standard-of-Care Multimodal Pain Therapy

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

其他：Standard-of-Care (SoC)

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).

其他：Standard-of-Care Multimodal Pain Therapy

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

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

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).

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).

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'.

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.

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).

Socioeconomic Data Questionnaire

Patients report socioeconomic data like work status (working, full time/part time, sick leave, retired, etc.)

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.

Safety Endpoints

• Adverse Events (AEs)
• Device Deficiencies (DDs)
• Serious Adverse Events (SAEs)