Neuromodulation complementary to physiotherapy in fibromyalgia and its electroencephalographic correlates: a randomized clinical trial protocol
DOI:
https://doi.org/10.33448/rsd-v9i9.6799Keywords:
Fibromyalgia; Transcranial direct current stimulation; Exercise therapy; Pain; Anxiety; DepressionAbstract
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.
References
Beck, A. T., Epstein, N., Brown, G., & Steer, R. A. (1988). An inventory for measuring clinical anxiety: psychometric properties. Journal of Consulting and Clinical Psychology, 56(6), 893-897.
Beck, A. T., Steer, R. A., & Carbin, M. G. (1988). Psychometric properties of the Beck Depression Inventory: Twenty-five years of evaluation. Clinical Psychology Review, 8(1), 77-100.
Bell, I. R., Lewis, D. A., Lewis, S. E., Schwartz, G. E., Brooks, A. J., Scott, A., & Baldwin, C. M. (2004). EEG alpha sensitization in individualized homeopathic treatment of fibromyalgia. International Journal of Neuroscience, 114(9), 1195-1220.
Boonstra, T. W., Nikolin, S., Meisener, A. C., Martin, D. M., & Loo, C. K. (2016). Change in mean frequency of resting-state electroencephalography after transcranial direct current stimulation. Frontiers in Human Neuroscience, 10, 1-13.
Cruccu, G., Garcia‐Larrea, L., Hansson, P., Keindl, M., Lefaucheur, J. P., Paulus, W., ... & Attal, N. (2016). EAN guidelines on central neurostimulation therapy in chronic pain conditions. European Journal of Neurology, 23(10), 1489-1499.
Cummiford, C. M., Nascimento, T. D., Foerster, B. R., Clauw, D. J., Zubieta, J. K., Harris, R. E., & Da Silva, A. F. (2016). Changes in resting state functional connectivity after repetitive transcranial direct current stimulation applied to motor cortex in fibromyalgia patients. Arthritis Research & Therapy, 18(1), 1-12.
Dos Santos Sabbag, L. M., Dourado, M. P., Júnior, P. Y., Novo, N. F., Kaziyama, H. H. S., Miyazaki, M. H., & Battistella, L. R. (2000). Estudo ergométrico evolutivo de portadoras de fibromialgia primária em programa de treinamento cardiovascular supervisionado. Acta Fisiátrica, 7(1), 29-34.
Duquette, M., Roy, M., Lepore, F., Peretz, I., & Rainville, P. (2007). Cerebral mechanisms involved in the interaction between pain and emotion. Revue Neurologique, 163(2), 169-179.
Fagerlund, A. J., Hansen, O. A., & Aslaksen, P. M. (2015). Transcranial direct current stimulation as a treatment for patients with fibromyalgia: a randomized controlled trial. Pain, 156(1), 62-71.
Foerster, B. R., Nascimento, T. D., DeBoer, M., Bender, M. A., Rice, I. C., Truong, D. Q., ... & DaSilva, A. F. (2015). Excitatory and inhibitory brain metabolites as targets and predictors of effective motor cortex tDCS therapy in fibromyalgia. Arthritis & Rheumatology (Hoboken, NJ), 67(2), 576.
Folstein, M. F., Folstein, S. E., & McHugh, P. R. (1975). “Mini-mental state”: a practical method for grading the cognitive state of patients for the clinician. Journal of Psychiatric Rresearch, 12(3), 189-198.
Goldenberg, D. L. (1999). Fibromyalgia syndrome a decade later: what have we learned?. Archives of Internal Medicine, 159(8), 777-785.
Goldenberg, D. L., Bradley, L. A., Arnold, L. M., Glass, J. M., & Clauw, D. J. (2008). Understanding fibromyalgia and its related disorders. Primary Care Companion to The Journal of Clinical Psychiatry, 10(2), 133-144.
González-Roldán, A. M., Cifre, I., Sitges, C., & Montoya, P. (2016). Altered dynamic of EEG oscillations in fibromyalgia patients at rest. Pain Medicine, 17(6), 1058-1068.
Häkkinen, A., Häkkinen, K., Hannonen, P., & Alen, M. (2001). Strength training induced adaptations in neuromuscular function of premenopausal women with fibromyalgia: comparison with healthy women. Annals of the rheumatic diseases, 60(1), 21-26.
Hargrove, J. B., Bennett, R. M., Simons, D. G., Smith, S. J., Nagpal, S., & Deering, D. E. (2010). Quantitative electroencephalographic abnormalities in fibromyalgia patients. Clinical EEG and Neuroscience, 41(3), 132-139.
Hassan, M. A., Fraser, M., Conway, B. A., Allan, D. B., & Vuckovic, A. (2015). The mechanism of neurofeedback training for treatment of central neuropathic pain in paraplegia: a pilot study. BMC Neurology, 15(1), 200.
Häuser, W. (2016). Fibromyalgia syndrome: Basic knowledge, diagnosis and treatment. Medizinische Monatsschrift fur Pharmazeuten, 39(12), 504-511.
Helfenstein, M. Jr., M. H., Goldenfum, M. A., & Siena, C. A. F. (2012). Fibromialgia: aspectos clínicos e ocupacionais. Revista da Associação Médica Brasileira, 58(3), 358-365.
Heymann, R. E., Paiva, E. D. S., Helfenstein, M. Jr., Pollak, D. F., Martinez, J. E., Provenza, J. R., ... & Lage, L. V. (2010). Consenso brasileiro do tratamento da fibromialgia. Revista Brasileira de Reumatologia, 50(1), 56-66.
Hou, W. H., Wang, T. Y., & Kang, J. H. (2016). The effects of add-on non-invasive brain stimulation in fibromyalgia: a meta-analysis and meta-regression of randomized controlled trials. Rheumatology, 55(8), 1507-1517.
Johns, M. W. (1991). A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep, 14(6), 540-545.
Kopf, A., & Patel, N. B. (2010). Guia para o Tratamento da dor em contextos de poucos recursos. Washington: International Association for the Study of Pain (IASP), 1-418.
Linn, B. S., Linn, M. W., & Gurel, L. E. E. (1968). Cumulative illness rating scale. Journal of the American Geriatrics Society, 16(5), 622-626.
Mendonca, M. E., Simis, M., Grecco, L. C., Battistella, L. R., Baptista, A. F., & Fregni, F. (2016). Transcranial direct current stimulation combined with aerobic exercise to optimize analgesic responses in fibromyalgia: A randomized placebo-controlled clinical trial. Frontiers in Human Neuroscience, 10, 1-12.
Pereira, A. S., Shitsuka, D. M., Parreira, F. J., & Shitsuka, R. (2018). Metodologia da pesquisa científica. . [e-book]. Santa Maria. Ed. UAB/NTE/UFSM.
Silva, A. F., Zortea, M., Carvalho, S., Leite, J., da Silva Torres, I. L., Fregni, F., & Caumo, W. (2017). Anodal transcranial direct current stimulation over the left dorsolateral prefrontal cortex modulates attention and pain in fibromyalgia: randomized clinical trial. Scientific Reports, 7, 1-11.
Song, M., Shin, Y., & Yun, K. (2014). Beta-frequency EEG activity increased during transcranial direct current stimulation. Neuroreport, 25(18), 1433-1436.
Tiemann, L., Schulz, E., Winkelmann, A., Ronel, J., Henningsen, P., & Ploner, M. (2012). Behavioral and neuronal investigations of hypervigilance in patients with fibromyalgia syndrome. PloS One, 7(4), 1-8.
Winkler, I., Haufe, S., & Tangermann, M. (2011). Automatic classification of artifactual ICA-components for artifact removal in EEG signals. Behavioral and Brain Functions, 7(1), 1-15.
Zhu, C. E., Yu, B., Zhang, W., Chen, W. H., Qi, Q., & Miao, Y. (2017). Effectiveness and safety of transcranial direct current stimulation in fibromyalgia: A systematic review and meta-analysis. Journal of Rehabilitation Medicine, 49(1), 2-9.
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Copyright (c) 2020 Géssika Araújo de Melo, Eliane Araújo de Oliveira, Suellen Mary Marinho dos Santos Andrade, Nelso Torro
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