Treatment of comorbid migraine and temporomandibular disorders: A factorial, double-blind, randomized, placebo-controlled study

Detalhes bibliográficos
Autor(a) principal: Gonçalves, Daniela A.G. [UNESP]
Data de Publicação: 2013
Outros Autores: Camparis, Cinara M. [UNESP], Speciali, José G., Castanharo, Sabrina M. [UNESP], Ujikawa, Liliana T., Lipton, Richard B., Bigal, Marcelo E.
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UNESP
Texto Completo: http://dx.doi.org/10.11607/jop.1096
http://hdl.handle.net/11449/227481
Resumo: Aims: To investigate the effectiveness of single and concomitant treatment of migraine and temporomandibular disorders (TMD) in women with the comorbidity. Methods: Eligible female patients met International Classification of Headache Disorders, second edition (ICHD-2) criteria for migraine with or without aura and the Research Diagnostic Criteria for myofascial TMD (Grade ll or lll). After a run-in period (30 days), women with both migraine and TMD were enrolled into a four-arm, double-blind, placebocontrolled, factorial study testing the separate and joint effects of a migraine treatment (propranolol 90 mg) and a TMD treatment (stabilization splint [SS]) in four groups of patients. The four treatment groups were propranolol and SS (n = 22); propranolol placebo and SS (n = 23); propranolol and non-occlusal splint (NOS) (n = 23); and propranolol placebo and NOS (n = 21). The primary endpoint for migraine was change in headache days from baseline to the third month, and the secondary endpoint was change in days with at least moderate headache in the same period. The TMD endpoints included pain threshold and mandibular vertical range of motion. Data were analyzed using analysis of variance (ANOVA, Dunn's post-hoc test) or Kruskal-Wallis test. Results: For the primary endpoint, in intention-to-treat (ITT) analyses (n = 94), propranolol and SS were associated with a nonsignificant reduction in the number of headache days, relative to all other groups. For per-protocol (PP) Completer analyses (n = 89), differences in the number of headache days reached significance (P < .05). The propranolol and SS group was significantly superior to the other groups on all other headache endpoints and in disability, in both ITT and PP analyses. No significant differences among groups were seen for the TMD parameters. Conclusion: In women with TMD and migraine, migraine significantly improved only when both conditions were treated. The best treatment choice for TMD pain in women with migraine is yet to be defined.
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spelling Treatment of comorbid migraine and temporomandibular disorders: A factorial, double-blind, randomized, placebo-controlled studyClinical trialMigraineOcclusal splintPropranololTemporomandibular disordersAims: To investigate the effectiveness of single and concomitant treatment of migraine and temporomandibular disorders (TMD) in women with the comorbidity. Methods: Eligible female patients met International Classification of Headache Disorders, second edition (ICHD-2) criteria for migraine with or without aura and the Research Diagnostic Criteria for myofascial TMD (Grade ll or lll). After a run-in period (30 days), women with both migraine and TMD were enrolled into a four-arm, double-blind, placebocontrolled, factorial study testing the separate and joint effects of a migraine treatment (propranolol 90 mg) and a TMD treatment (stabilization splint [SS]) in four groups of patients. The four treatment groups were propranolol and SS (n = 22); propranolol placebo and SS (n = 23); propranolol and non-occlusal splint (NOS) (n = 23); and propranolol placebo and NOS (n = 21). The primary endpoint for migraine was change in headache days from baseline to the third month, and the secondary endpoint was change in days with at least moderate headache in the same period. The TMD endpoints included pain threshold and mandibular vertical range of motion. Data were analyzed using analysis of variance (ANOVA, Dunn's post-hoc test) or Kruskal-Wallis test. Results: For the primary endpoint, in intention-to-treat (ITT) analyses (n = 94), propranolol and SS were associated with a nonsignificant reduction in the number of headache days, relative to all other groups. For per-protocol (PP) Completer analyses (n = 89), differences in the number of headache days reached significance (P < .05). The propranolol and SS group was significantly superior to the other groups on all other headache endpoints and in disability, in both ITT and PP analyses. No significant differences among groups were seen for the TMD parameters. Conclusion: In women with TMD and migraine, migraine significantly improved only when both conditions were treated. The best treatment choice for TMD pain in women with migraine is yet to be defined.Department of Dental Materials and Prosthodontics UNESP-Univ Estadual Paulista Campus AraraquaraDepartment of Neurology School of Medicine University of São Paulo Ribeirao PretoMontefiore Headache Center Albert Einstein College of MedicineLabrys Biologics IncDepartment of Dental Materials and Prosthodontics UNESP-Univ Estadual Paulista Campus AraraquaraUniversidade Estadual Paulista (UNESP)Universidade de São Paulo (USP)Albert Einstein College of MedicineIncGonçalves, Daniela A.G. [UNESP]Camparis, Cinara M. [UNESP]Speciali, José G.Castanharo, Sabrina M. [UNESP]Ujikawa, Liliana T.Lipton, Richard B.Bigal, Marcelo E.2022-04-29T07:13:26Z2022-04-29T07:13:26Z2013-01-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article325-335http://dx.doi.org/10.11607/jop.1096Journal of Oral and Facial Pain and Headache, v. 27, n. 4, p. 325-335, 2013.2333-03762333-0384http://hdl.handle.net/11449/22748110.11607/jop.10962-s2.0-84892697740Scopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengJournal of Oral and Facial Pain and Headacheinfo:eu-repo/semantics/openAccess2022-04-29T07:13:26Zoai:repositorio.unesp.br:11449/227481Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462022-04-29T07:13:26Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false
dc.title.none.fl_str_mv Treatment of comorbid migraine and temporomandibular disorders: A factorial, double-blind, randomized, placebo-controlled study
title Treatment of comorbid migraine and temporomandibular disorders: A factorial, double-blind, randomized, placebo-controlled study
spellingShingle Treatment of comorbid migraine and temporomandibular disorders: A factorial, double-blind, randomized, placebo-controlled study
Gonçalves, Daniela A.G. [UNESP]
Clinical trial
Migraine
Occlusal splint
Propranolol
Temporomandibular disorders
title_short Treatment of comorbid migraine and temporomandibular disorders: A factorial, double-blind, randomized, placebo-controlled study
title_full Treatment of comorbid migraine and temporomandibular disorders: A factorial, double-blind, randomized, placebo-controlled study
title_fullStr Treatment of comorbid migraine and temporomandibular disorders: A factorial, double-blind, randomized, placebo-controlled study
title_full_unstemmed Treatment of comorbid migraine and temporomandibular disorders: A factorial, double-blind, randomized, placebo-controlled study
title_sort Treatment of comorbid migraine and temporomandibular disorders: A factorial, double-blind, randomized, placebo-controlled study
author Gonçalves, Daniela A.G. [UNESP]
author_facet Gonçalves, Daniela A.G. [UNESP]
Camparis, Cinara M. [UNESP]
Speciali, José G.
Castanharo, Sabrina M. [UNESP]
Ujikawa, Liliana T.
Lipton, Richard B.
Bigal, Marcelo E.
author_role author
author2 Camparis, Cinara M. [UNESP]
Speciali, José G.
Castanharo, Sabrina M. [UNESP]
Ujikawa, Liliana T.
Lipton, Richard B.
Bigal, Marcelo E.
author2_role author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universidade Estadual Paulista (UNESP)
Universidade de São Paulo (USP)
Albert Einstein College of Medicine
Inc
dc.contributor.author.fl_str_mv Gonçalves, Daniela A.G. [UNESP]
Camparis, Cinara M. [UNESP]
Speciali, José G.
Castanharo, Sabrina M. [UNESP]
Ujikawa, Liliana T.
Lipton, Richard B.
Bigal, Marcelo E.
dc.subject.por.fl_str_mv Clinical trial
Migraine
Occlusal splint
Propranolol
Temporomandibular disorders
topic Clinical trial
Migraine
Occlusal splint
Propranolol
Temporomandibular disorders
description Aims: To investigate the effectiveness of single and concomitant treatment of migraine and temporomandibular disorders (TMD) in women with the comorbidity. Methods: Eligible female patients met International Classification of Headache Disorders, second edition (ICHD-2) criteria for migraine with or without aura and the Research Diagnostic Criteria for myofascial TMD (Grade ll or lll). After a run-in period (30 days), women with both migraine and TMD were enrolled into a four-arm, double-blind, placebocontrolled, factorial study testing the separate and joint effects of a migraine treatment (propranolol 90 mg) and a TMD treatment (stabilization splint [SS]) in four groups of patients. The four treatment groups were propranolol and SS (n = 22); propranolol placebo and SS (n = 23); propranolol and non-occlusal splint (NOS) (n = 23); and propranolol placebo and NOS (n = 21). The primary endpoint for migraine was change in headache days from baseline to the third month, and the secondary endpoint was change in days with at least moderate headache in the same period. The TMD endpoints included pain threshold and mandibular vertical range of motion. Data were analyzed using analysis of variance (ANOVA, Dunn's post-hoc test) or Kruskal-Wallis test. Results: For the primary endpoint, in intention-to-treat (ITT) analyses (n = 94), propranolol and SS were associated with a nonsignificant reduction in the number of headache days, relative to all other groups. For per-protocol (PP) Completer analyses (n = 89), differences in the number of headache days reached significance (P < .05). The propranolol and SS group was significantly superior to the other groups on all other headache endpoints and in disability, in both ITT and PP analyses. No significant differences among groups were seen for the TMD parameters. Conclusion: In women with TMD and migraine, migraine significantly improved only when both conditions were treated. The best treatment choice for TMD pain in women with migraine is yet to be defined.
publishDate 2013
dc.date.none.fl_str_mv 2013-01-01
2022-04-29T07:13:26Z
2022-04-29T07:13:26Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://dx.doi.org/10.11607/jop.1096
Journal of Oral and Facial Pain and Headache, v. 27, n. 4, p. 325-335, 2013.
2333-0376
2333-0384
http://hdl.handle.net/11449/227481
10.11607/jop.1096
2-s2.0-84892697740
url http://dx.doi.org/10.11607/jop.1096
http://hdl.handle.net/11449/227481
identifier_str_mv Journal of Oral and Facial Pain and Headache, v. 27, n. 4, p. 325-335, 2013.
2333-0376
2333-0384
10.11607/jop.1096
2-s2.0-84892697740
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Journal of Oral and Facial Pain and Headache
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 325-335
dc.source.none.fl_str_mv Scopus
reponame:Repositório Institucional da UNESP
instname:Universidade Estadual Paulista (UNESP)
instacron:UNESP
instname_str Universidade Estadual Paulista (UNESP)
instacron_str UNESP
institution UNESP
reponame_str Repositório Institucional da UNESP
collection Repositório Institucional da UNESP
repository.name.fl_str_mv Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)
repository.mail.fl_str_mv
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