Neuromodulation complementary to physiotherapy in fibromyalgia and its electroencephalographic correlates: a randomized clinical trial protocol
Autor(a) principal: | |
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Data de Publicação: | 2020 |
Outros Autores: | , , |
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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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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1797052738544074752 |