Cargando…

Non-Invasive Transcutaneous Vagus Nerve Stimulation for the Treatment of Fibromyalgia Symptoms: A Study Protocol

Stimulation of the vagus nerve, a parasympathetic nerve that controls the neuro-digestive, vascular, and immune systems, induces pain relief, particularly in clinical conditions such as headache and rheumatoid arthritis. Transmission through vagal afferents towards the nucleus of the solitary tract...

Descripción completa

Detalles Bibliográficos
Autores principales: Molero-Chamizo, Andrés, Nitsche, Michael A., Bolz, Armin, Andújar Barroso, Rafael Tomás, Alameda Bailén, José R., García Palomeque, Jesús Carlos, Rivera-Urbina, Guadalupe Nathzidy
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8774206/
https://www.ncbi.nlm.nih.gov/pubmed/35053839
http://dx.doi.org/10.3390/brainsci12010095
_version_ 1784636281479757824
author Molero-Chamizo, Andrés
Nitsche, Michael A.
Bolz, Armin
Andújar Barroso, Rafael Tomás
Alameda Bailén, José R.
García Palomeque, Jesús Carlos
Rivera-Urbina, Guadalupe Nathzidy
author_facet Molero-Chamizo, Andrés
Nitsche, Michael A.
Bolz, Armin
Andújar Barroso, Rafael Tomás
Alameda Bailén, José R.
García Palomeque, Jesús Carlos
Rivera-Urbina, Guadalupe Nathzidy
author_sort Molero-Chamizo, Andrés
collection PubMed
description Stimulation of the vagus nerve, a parasympathetic nerve that controls the neuro-digestive, vascular, and immune systems, induces pain relief, particularly in clinical conditions such as headache and rheumatoid arthritis. Transmission through vagal afferents towards the nucleus of the solitary tract (NST), the central relay nucleus of the vagus nerve, has been proposed as the main physiological mechanism that reduces pain intensity after vagal stimulation. Chronic pain symptoms of fibromyalgia patients might benefit from stimulation of the vagus nerve via normalization of altered autonomic and immune systems causing their respective symptoms. However, multi-session non-invasive vagal stimulation effects on fibromyalgia have not been evaluated in randomized clinical trials. We propose a parallel group, sham-controlled, randomized study to modulate the sympathetic–vagal balance and pain intensity in fibromyalgia patients by application of non-invasive transcutaneous vagus nerve stimulation (tVNS) over the vagal auricular and cervical branches. We will recruit 136 fibromyalgia patients with chronic moderate to high pain intensity. The primary outcome measure will be pain intensity, and secondary measures will be fatigue, health-related quality of life, sleep disorders, and depression. Heart rate variability and pro-inflammatory cytokine levels will be obtained as secondary physiological measures. We hypothesize that multiple tVNS sessions (five per week, for 4 weeks) will reduce pain intensity and improve quality of life as a result of normalization of the vagal control of nociception and immune–autonomic functions. Since both vagal branches project to the NST, we do not predict significantly different results between the two stimulation protocols.
format Online
Article
Text
id pubmed-8774206
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-87742062022-01-21 Non-Invasive Transcutaneous Vagus Nerve Stimulation for the Treatment of Fibromyalgia Symptoms: A Study Protocol Molero-Chamizo, Andrés Nitsche, Michael A. Bolz, Armin Andújar Barroso, Rafael Tomás Alameda Bailén, José R. García Palomeque, Jesús Carlos Rivera-Urbina, Guadalupe Nathzidy Brain Sci Study Protocol Stimulation of the vagus nerve, a parasympathetic nerve that controls the neuro-digestive, vascular, and immune systems, induces pain relief, particularly in clinical conditions such as headache and rheumatoid arthritis. Transmission through vagal afferents towards the nucleus of the solitary tract (NST), the central relay nucleus of the vagus nerve, has been proposed as the main physiological mechanism that reduces pain intensity after vagal stimulation. Chronic pain symptoms of fibromyalgia patients might benefit from stimulation of the vagus nerve via normalization of altered autonomic and immune systems causing their respective symptoms. However, multi-session non-invasive vagal stimulation effects on fibromyalgia have not been evaluated in randomized clinical trials. We propose a parallel group, sham-controlled, randomized study to modulate the sympathetic–vagal balance and pain intensity in fibromyalgia patients by application of non-invasive transcutaneous vagus nerve stimulation (tVNS) over the vagal auricular and cervical branches. We will recruit 136 fibromyalgia patients with chronic moderate to high pain intensity. The primary outcome measure will be pain intensity, and secondary measures will be fatigue, health-related quality of life, sleep disorders, and depression. Heart rate variability and pro-inflammatory cytokine levels will be obtained as secondary physiological measures. We hypothesize that multiple tVNS sessions (five per week, for 4 weeks) will reduce pain intensity and improve quality of life as a result of normalization of the vagal control of nociception and immune–autonomic functions. Since both vagal branches project to the NST, we do not predict significantly different results between the two stimulation protocols. MDPI 2022-01-12 /pmc/articles/PMC8774206/ /pubmed/35053839 http://dx.doi.org/10.3390/brainsci12010095 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Study Protocol
Molero-Chamizo, Andrés
Nitsche, Michael A.
Bolz, Armin
Andújar Barroso, Rafael Tomás
Alameda Bailén, José R.
García Palomeque, Jesús Carlos
Rivera-Urbina, Guadalupe Nathzidy
Non-Invasive Transcutaneous Vagus Nerve Stimulation for the Treatment of Fibromyalgia Symptoms: A Study Protocol
title Non-Invasive Transcutaneous Vagus Nerve Stimulation for the Treatment of Fibromyalgia Symptoms: A Study Protocol
title_full Non-Invasive Transcutaneous Vagus Nerve Stimulation for the Treatment of Fibromyalgia Symptoms: A Study Protocol
title_fullStr Non-Invasive Transcutaneous Vagus Nerve Stimulation for the Treatment of Fibromyalgia Symptoms: A Study Protocol
title_full_unstemmed Non-Invasive Transcutaneous Vagus Nerve Stimulation for the Treatment of Fibromyalgia Symptoms: A Study Protocol
title_short Non-Invasive Transcutaneous Vagus Nerve Stimulation for the Treatment of Fibromyalgia Symptoms: A Study Protocol
title_sort non-invasive transcutaneous vagus nerve stimulation for the treatment of fibromyalgia symptoms: a study protocol
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8774206/
https://www.ncbi.nlm.nih.gov/pubmed/35053839
http://dx.doi.org/10.3390/brainsci12010095
work_keys_str_mv AT molerochamizoandres noninvasivetranscutaneousvagusnervestimulationforthetreatmentoffibromyalgiasymptomsastudyprotocol
AT nitschemichaela noninvasivetranscutaneousvagusnervestimulationforthetreatmentoffibromyalgiasymptomsastudyprotocol
AT bolzarmin noninvasivetranscutaneousvagusnervestimulationforthetreatmentoffibromyalgiasymptomsastudyprotocol
AT andujarbarrosorafaeltomas noninvasivetranscutaneousvagusnervestimulationforthetreatmentoffibromyalgiasymptomsastudyprotocol
AT alamedabailenjoser noninvasivetranscutaneousvagusnervestimulationforthetreatmentoffibromyalgiasymptomsastudyprotocol
AT garciapalomequejesuscarlos noninvasivetranscutaneousvagusnervestimulationforthetreatmentoffibromyalgiasymptomsastudyprotocol
AT riveraurbinaguadalupenathzidy noninvasivetranscutaneousvagusnervestimulationforthetreatmentoffibromyalgiasymptomsastudyprotocol