Neuromodulation complementary to physiotherapy in fibromyalgia and its electroencephalographic correlates: a randomized clinical trial protocol

Detalhes bibliográficos
Autor(a) principal: Melo, Géssika Araújo de
Data de Publicação: 2020
Outros Autores: Oliveira, Eliane Araújo de, Andrade, Suellen Mary Marinho dos Santos, Torro, Nelso
Tipo de documento: Artigo
Idioma: por
Título da fonte: Research, Society and Development
Texto Completo: https://rsdjournal.org/index.php/rsd/article/view/6799
Resumo: The objective of the present research is to present a protocol for a randomized, placebo-controlled triple-blind clinical trial, which will evaluate the effects of neuromodulation with transcranial direct current stimulation (tDCS) associated with physiotherapy treatment in fibromyalgia and its electroencephalographic correlates. The volunteers will be women diagnosed with fibromyalgia for at least three months, aged between 40 and 55 years. Participants will be randomly assigned to three groups: Group 1, with anodic stimulation in the left motor cortex and cathodic stimulation in the right supraorbital region; Group 2, with anodic stimulation in the left dorsolateral prefrontal cortex and cathodic stimulation in the right supraorbital region; and Group 3, with simulated type stimulation (sham). All groups will be accompanied by physiotherapy treatment. The primary outcomes will be the variations in pain, anxiety and depression levels, resulting from neuromodulation, as assessed by the Visual Analogue Scale and Beck's Anxiety and Depression Inventories, respectively. The secondary outcome will be the evaluation of the cortical electrical activity as registered by a 32-channel electroencephalogram. In data analysis, a mixed ANOVA will be used, with 3 groups of participants versus 2 moments of evaluation, with a level of significance of p<0.05. For pair comparisons, post hoc test with Bonferroni-Sidak correction will be used. Considering that fibromyalgia is a multifactorial disease, not very responsive to drugs and other conventional treatments, it is important to analyze the potential therapeutic effect of neuromodulation, in addition to the physiotherapeutic treatment, in individuals with fibromyalgia.
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spelling Neuromodulation complementary to physiotherapy in fibromyalgia and its electroencephalographic correlates: a randomized clinical trial protocolNeuromodulación complementaria a la fisioterapia en la fibromialgia y sus correlatos electroencefalográficos: un protocolo para un ensayo clínico aleatorizadoNeuromodulação complementar à fisioterapia na fibromialgia e seus correlatos eletroencefalográficos: um protocolo para ensaio clínico randomizadoFibromialgiaEstimulação transcraniana por corrente contínuaTerapia por exercícioDorAnsiedadeDepressãoFibromialgiaEstimulación transcraneal de corriente continuaTerapia de ejercicioDolorAnsiedadDepresiónFibromyalgiaTranscranial direct current stimulationExercise therapyPainAnxietyDepressionThe objective of the present research is to present a protocol for a randomized, placebo-controlled triple-blind clinical trial, which will evaluate the effects of neuromodulation with transcranial direct current stimulation (tDCS) associated with physiotherapy treatment in fibromyalgia and its electroencephalographic correlates. The volunteers will be women diagnosed with fibromyalgia for at least three months, aged between 40 and 55 years. Participants will be randomly assigned to three groups: Group 1, with anodic stimulation in the left motor cortex and cathodic stimulation in the right supraorbital region; Group 2, with anodic stimulation in the left dorsolateral prefrontal cortex and cathodic stimulation in the right supraorbital region; and Group 3, with simulated type stimulation (sham). All groups will be accompanied by physiotherapy treatment. The primary outcomes will be the variations in pain, anxiety and depression levels, resulting from neuromodulation, as assessed by the Visual Analogue Scale and Beck's Anxiety and Depression Inventories, respectively. The secondary outcome will be the evaluation of the cortical electrical activity as registered by a 32-channel electroencephalogram. In data analysis, a mixed ANOVA will be used, with 3 groups of participants versus 2 moments of evaluation, with a level of significance of p<0.05. For pair comparisons, post hoc test with Bonferroni-Sidak correction will be used. Considering that fibromyalgia is a multifactorial disease, not very responsive to drugs and other conventional treatments, it is important to analyze the potential therapeutic effect of neuromodulation, in addition to the physiotherapeutic treatment, in individuals with fibromyalgia.El objetivo de la presente investigación es presentar un protocolo para un ensayo clínico aleatorizado, triple ciego controlado con placebo, que evaluará los efectos de la neuromodulación con estimulación transcraneal de corriente continua (tDCS) asociada con el tratamiento de fisioterapia en la fibromialgia y sus correlatos electroencefalográficos. Las voluntarias serán mujeres diagnosticadas con fibromialgia durante al menos tres meses, con edades comprendidas entre 40 y 55 años. Los participantes se dividirán aleatoriamente en tres grupos: Grupo 1, con estimulación anódica en la corteza motora izquierda y estimulación catódica en la región supraorbital derecha; Grupo 2, con estimulación anódica en la corteza prefrontal dorsolateral izquierda y estimulación catódica en la región supraorbitaria derecha; y Grupo 3, con estimulación simulada (placebo). Todos los grupos estarán acompañados de un tratamiento de fisioterapia. Los resultados primarios serán variaciones en los niveles de dolor, ansiedad y depresión resultantes de la neuromodulación, evaluados por los Inventarios de Escala Visual Analógica y de Ansiedad y Depresión de Beck, respectivamente. El resultado secundario será la evaluación de la actividad eléctrica cortical registrada por el electroencefalograma de 32 canales. En el análisis de datos, se utilizará un ANOVA mixto, con 3 grupos de participantes versus 2 momentos de evaluación, con un nivel de significancia de p <0.05. Para las comparaciones entre pares, se utilizará la prueba post hoc con corrección de Bonferroni-Sidak. Teniendo en cuenta que la fibromialgia es una enfermedad multifactorial, que no responde muy bien a los medicamentos y otros tratamientos convencionales, es importante analizar el posible efecto terapéutico de la neuromodulación, además del tratamiento fisioterapéutico, en individuos con fibromialgia.O objetivo da presente pesquisa é apresentar um protocolo para um ensaio clínico randomizado, controlado por placebo, triplo-cego, que avaliará os efeitos da neuromodulação com a estimulação transcraniana por corrente direta (tDCS) associada ao tratamento fisioterapêutico na fibromyalgia e seus correlatos eletroencefalográficos. As voluntárias serão mulheres diagnosticadas com fibromialgia há pelo menos três meses, com idades entre 40 e 55 anos. As participantes serão divididas aleatoriamente em três grupos: Grupo 1, com estimulação anódica no córtex motor esquerdo e estimulação catódica na região supraorbital direita; Grupo 2, com estimulação anódica no córtex prefrontal dorsolateral esquerdo e estimulação catódica na região supraorbital direita; e Grupo 3, com estimulação do tipo simulada (placebo). Todos os grupos serão acompanhados por tratamento fisioterapêutico. Os desfechos primários serão as variações nos níveis de dor, ansiedade e depressão, resultantes da neuromodulação, avaliadas pela Escala Visual Analógica e Inventários de Ansiedade e Depressão de Beck, respectivamente. O resultado secundário será a avaliação da atividade elétrica cortical registrada pelo eletroencefalograma de 32 canais. Na análise dos dados, será utilizada uma ANOVA mista, com 3 grupos de participantes versus 2 momentos de avaliação, com nível de significância de p <0,05. Para comparações de pares, será utilizado o teste post hoc com correção de Bonferroni-Sidak. Considerando que a fibromialgia é uma doença multifatorial, pouco responsiva a medicamentos e outros tratamentos convencionais, é importante analisar o potencial efeito terapêutico da neuromodulação, além do tratamento fisioterapêutico, em indivíduos com fibromialgia.Research, Society and Development2020-08-18info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://rsdjournal.org/index.php/rsd/article/view/679910.33448/rsd-v9i9.6799Research, Society and Development; Vol. 9 No. 9; e292996799Research, Society and Development; Vol. 9 Núm. 9; e292996799Research, Society and Development; v. 9 n. 9; e2929967992525-3409reponame:Research, Society and Developmentinstname:Universidade Federal de Itajubá (UNIFEI)instacron:UNIFEIporhttps://rsdjournal.org/index.php/rsd/article/view/6799/6443Copyright (c) 2020 Géssika Araújo de Melo, Eliane Araújo de Oliveira, Suellen Mary Marinho dos Santos Andrade, Nelso Torrohttp://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessMelo, Géssika Araújo deOliveira, Eliane Araújo deAndrade, Suellen Mary Marinho dos SantosTorro, Nelso2020-09-18T01:42:11Zoai:ojs.pkp.sfu.ca:article/6799Revistahttps://rsdjournal.org/index.php/rsd/indexPUBhttps://rsdjournal.org/index.php/rsd/oairsd.articles@gmail.com2525-34092525-3409opendoar:2024-01-17T09:29:47.078071Research, Society and Development - Universidade Federal de Itajubá (UNIFEI)false
dc.title.none.fl_str_mv Neuromodulation complementary to physiotherapy in fibromyalgia and its electroencephalographic correlates: a randomized clinical trial protocol
Neuromodulación complementaria a la fisioterapia en la fibromialgia y sus correlatos electroencefalográficos: un protocolo para un ensayo clínico aleatorizado
Neuromodulação complementar à fisioterapia na fibromialgia e seus correlatos eletroencefalográficos: um protocolo para ensaio clínico randomizado
title Neuromodulation complementary to physiotherapy in fibromyalgia and its electroencephalographic correlates: a randomized clinical trial protocol
spellingShingle Neuromodulation complementary to physiotherapy in fibromyalgia and its electroencephalographic correlates: a randomized clinical trial protocol
Melo, Géssika Araújo de
Fibromialgia
Estimulação transcraniana por corrente contínua
Terapia por exercício
Dor
Ansiedade
Depressão
Fibromialgia
Estimulación transcraneal de corriente continua
Terapia de ejercicio
Dolor
Ansiedad
Depresión
Fibromyalgia
Transcranial direct current stimulation
Exercise therapy
Pain
Anxiety
Depression
title_short Neuromodulation complementary to physiotherapy in fibromyalgia and its electroencephalographic correlates: a randomized clinical trial protocol
title_full Neuromodulation complementary to physiotherapy in fibromyalgia and its electroencephalographic correlates: a randomized clinical trial protocol
title_fullStr Neuromodulation complementary to physiotherapy in fibromyalgia and its electroencephalographic correlates: a randomized clinical trial protocol
title_full_unstemmed Neuromodulation complementary to physiotherapy in fibromyalgia and its electroencephalographic correlates: a randomized clinical trial protocol
title_sort Neuromodulation complementary to physiotherapy in fibromyalgia and its electroencephalographic correlates: a randomized clinical trial protocol
author Melo, Géssika Araújo de
author_facet Melo, Géssika Araújo de
Oliveira, Eliane Araújo de
Andrade, Suellen Mary Marinho dos Santos
Torro, Nelso
author_role author
author2 Oliveira, Eliane Araújo de
Andrade, Suellen Mary Marinho dos Santos
Torro, Nelso
author2_role author
author
author
dc.contributor.author.fl_str_mv Melo, Géssika Araújo de
Oliveira, Eliane Araújo de
Andrade, Suellen Mary Marinho dos Santos
Torro, Nelso
dc.subject.por.fl_str_mv Fibromialgia
Estimulação transcraniana por corrente contínua
Terapia por exercício
Dor
Ansiedade
Depressão
Fibromialgia
Estimulación transcraneal de corriente continua
Terapia de ejercicio
Dolor
Ansiedad
Depresión
Fibromyalgia
Transcranial direct current stimulation
Exercise therapy
Pain
Anxiety
Depression
topic Fibromialgia
Estimulação transcraniana por corrente contínua
Terapia por exercício
Dor
Ansiedade
Depressão
Fibromialgia
Estimulación transcraneal de corriente continua
Terapia de ejercicio
Dolor
Ansiedad
Depresión
Fibromyalgia
Transcranial direct current stimulation
Exercise therapy
Pain
Anxiety
Depression
description The objective of the present research is to present a protocol for a randomized, placebo-controlled triple-blind clinical trial, which will evaluate the effects of neuromodulation with transcranial direct current stimulation (tDCS) associated with physiotherapy treatment in fibromyalgia and its electroencephalographic correlates. The volunteers will be women diagnosed with fibromyalgia for at least three months, aged between 40 and 55 years. Participants will be randomly assigned to three groups: Group 1, with anodic stimulation in the left motor cortex and cathodic stimulation in the right supraorbital region; Group 2, with anodic stimulation in the left dorsolateral prefrontal cortex and cathodic stimulation in the right supraorbital region; and Group 3, with simulated type stimulation (sham). All groups will be accompanied by physiotherapy treatment. The primary outcomes will be the variations in pain, anxiety and depression levels, resulting from neuromodulation, as assessed by the Visual Analogue Scale and Beck's Anxiety and Depression Inventories, respectively. The secondary outcome will be the evaluation of the cortical electrical activity as registered by a 32-channel electroencephalogram. In data analysis, a mixed ANOVA will be used, with 3 groups of participants versus 2 moments of evaluation, with a level of significance of p<0.05. For pair comparisons, post hoc test with Bonferroni-Sidak correction will be used. Considering that fibromyalgia is a multifactorial disease, not very responsive to drugs and other conventional treatments, it is important to analyze the potential therapeutic effect of neuromodulation, in addition to the physiotherapeutic treatment, in individuals with fibromyalgia.
publishDate 2020
dc.date.none.fl_str_mv 2020-08-18
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://rsdjournal.org/index.php/rsd/article/view/6799
10.33448/rsd-v9i9.6799
url https://rsdjournal.org/index.php/rsd/article/view/6799
identifier_str_mv 10.33448/rsd-v9i9.6799
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://rsdjournal.org/index.php/rsd/article/view/6799/6443
dc.rights.driver.fl_str_mv http://creativecommons.org/licenses/by/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv http://creativecommons.org/licenses/by/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Research, Society and Development
publisher.none.fl_str_mv Research, Society and Development
dc.source.none.fl_str_mv Research, Society and Development; Vol. 9 No. 9; e292996799
Research, Society and Development; Vol. 9 Núm. 9; e292996799
Research, Society and Development; v. 9 n. 9; e292996799
2525-3409
reponame:Research, Society and Development
instname:Universidade Federal de Itajubá (UNIFEI)
instacron:UNIFEI
instname_str Universidade Federal de Itajubá (UNIFEI)
instacron_str UNIFEI
institution UNIFEI
reponame_str Research, Society and Development
collection Research, Society and Development
repository.name.fl_str_mv Research, Society and Development - Universidade Federal de Itajubá (UNIFEI)
repository.mail.fl_str_mv rsd.articles@gmail.com
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