Condition: Chronic Back Pain · Sponsor: Medical University of Vienna
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 treat…
This description comes directly from the study's public registry record.
Richard Crevenna, Univ.-Prof. Dr. MBA, MSc, MSc · +43/1 40400-43330 · richard.crevenna@meduniwien.ac.at
Timothy Hasenöhrl, PD Dr. MSc, BSc · timothy.hasenoehrl@meduniwien.ac.at
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| BVAEB Rehazentrum Engelsbad | Baden, Lower Austria, Austria | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07529392