The therapeutic action of aVNS in pain treatment is based on the masking of pain by the electrical stimulation pulses, the activation of inhibiting pain control systems, and the release of neurotransmitters, such as endorphins. Pairing VNS stimulation with exercise and physiotherapy has yielded beneficial results in stroke patients as well as in smaller studies with back pain patients, already in short periods of time (2-4 weeks).
The current study is intended to evaluate the performance of percutaneous auricular Vagus Nerve Stimulation (pVNS) in combination with Standard-of-Care (SoC) in a 3-week in-patient rehabilitation setting, in patients with chronic musculoskeletal/myofascial back pain. This will be a prospective, open, randomized, controlled pilot study to evaluate pVNS using the VIVO® wearable medical device for personalized pain treatment, in terms of feasibility, efficacy, and safety in combination with rehabilitation training. Patients will be randomized into one of the following treatment groups:
* Group A: VIVO® (pVNS) + SoC (treatment group) * Group B: SoC (control/comparator group) Patients will remain on treatment for 3 weeks. This is comparable to other studies performed earlier, which showed safe and effective use of pVNS in chronic pain patients. The additional follow-up period of 3 weeks (optional 3 months and 6 months) allows to evaluate sustainable effects of treatment and late time effects, as previously shown in other studies.
Patients in the treatment group (VIVO® + SoC) will receive personalized aVNS therapy in combination with SoC. Personalization of VIVO® treatment is performed based on the individual perception level of the stimulation at the ear with regards to the stimulation amplitude (in Group A). Amplitude is adjusted (range 0-5 V) to reach a distinct but comfortable tingling sensation to reach activation of Aβ-fibers of the auricular vagus nerve but not Aδ-fibers producing a sensation of pain. Not only the Investigator is able to adjust the amplitude at the trial visit (via VIVO® Pen) but also the patient is able to adjust the amplitude according to his/her perception.
Patients will be randomized in this pilot study to receive either aVNS with the VIVO® system in addition to SoC vs. SoC alone as comparator group. Estimates of performance endpoints will thus be contrasted between aVNS and an established treatment option in this indication and controlled for regression to the mean and other forms of sampling bias.
All concomitant medication and therapies will be thoroughly documented and taken into account in the final analysis.
Male or female aged ≥30 and ≤65 years
Indication: chronic myofascial/musculoskeletal back pain
normal function of spinal nerves
Intractable pain for more than 6 months
Organic back pain (trauma, fracture, tumor, infection, severe degenerative spine, documented high-grade spinal stenosis, rheumatologic conditions)
Indication for back surgery
Radicular pain
Back surgery within the last 6 months
Parallel
Percutaneous auricular vagus nerve stimulation (pVNS)
DevicePersonalized pain treatment through percutaneous auricular vagus nerve stimulation (pVNS) in addition to standard rehabilitation.
Standard of care
Other interventionStandard of care rehabilitation training, in the course of the in-patient rehabilitation
Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) is a self-administered, 10-item questionnaire used to measure permanent functional disability in patients with low back pain. It assesses functional limitations in daily activities like pain intensity, personal hygiene, lifting, walking, sleeping, and social life, scoring from 0 (minimum, no pain-related disability) to 100 (maximum, highest possible pain-related disability).
VIVO® Perception & Usability Questionnaire
The VIVO® Perception \& Usability Questionnare is a qualitative questionnaire to evaluate user acceptance, where only some questions include numerical (quantitative) ratings from 1-5 to assess usability, with 1 being the least satisfying user experience and 5 the best user experience. Each question will be analyzed separately.
Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) is a self-administered, 10-item questionnaire used to measure permanent functional disability in patients with low back pain. It assesses functional limitations in daily activities like pain intensity, personal hygiene, lifting, walking, sleeping, and social life, scoring from 0 (minimum, no pain-related disability) to 100 (maximum, highest possible pain-related disability).
painDETECT
The painDETECT questionnaire (PD-Q) is a screening tool used to identify neuropathic pain components, with a total score ranging from to 38. A score of indicates a \>90% likelihood of neuropathic pain, 13-18 suggests a possible or transitional neuropathic component, and suggests a lower likelihood, often indicating nociceptive pain.
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
The EuroQol 5-Dimension 5-Level (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 (1 to 5). The results for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The higher the score the worse the outcome. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of subjective health perception. the higher the VAS the better the patients subjective health rating (0-100).
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