BMJ open · 2018
Photomodulation in the treatment of chronic pain in patients with temporomandibular disorder: protocol for cost-effectiveness analysis.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Sobral Ana Paula Taboada, Godoy Camila Leal H de, Fernandes Kristianne P Santos, Bussadori Sandra Kalil, Ferrari Raquel Agnelli Mesquita, Horliana Anna Carolina Ratto Tempestini, Monken Sonia F, Motta Lara J
Аннотация
INTRODUCTION: Epidemiological data show that the signs and symptoms of temporomandibular disorder (TMD) start becoming apparent from 6 years of age, and during adolescence these signs and symptoms are similar to those of adults. The present study aims to estimate the direct costs for treatment of chronic muscle pain with photobiomodulation therapy, occlusal splint and placebo in patients with TMD; to evaluate the effectiveness of photobiomodulation therapy and occlusal splint for treatment of muscle pain in patients with TMD; to analyse the cost-effectiveness of the two proposed treatments for pain; and to describe and compare the results of the analyses of these treatments.
METHODS AND ANALYSIS: This is a prospective trial of clinical and economic analyses that will include 135 patientswith TMD aged between 15 years and 25 years, randomly assigned to a treatment group: G1 (photobiomodulation), G2 (occlusal splint) and G3 (placebo). The analyses will be based on the cost of each treatment during the 12-month period. The outcome of the analysis of effectiveness will be pain, measured periodically by means of clinical examination of Research Diagnostic Criteria for Temporomandibular Disorders. The cost-effectiveness ratio will be calculated using, as end points, pain and the ratio of the differences in costs between the groups studied. The evaluation of the impact of the treatment on quality of life will be determined by applying the adapted EuroQol-5D.
ETHICS AND DISSEMINATION: This protocol has been ethically approved by the local medical ethical committee, protocol number 2.014.339. Results will be submitted to international peer-reviewed journals and presented at international conferences.
TRIAL REGISTRATION NUMBER: NCT03096301.
METHODS AND ANALYSIS: This is a prospective trial of clinical and economic analyses that will include 135 patientswith TMD aged between 15 years and 25 years, randomly assigned to a treatment group: G1 (photobiomodulation), G2 (occlusal splint) and G3 (placebo). The analyses will be based on the cost of each treatment during the 12-month period. The outcome of the analysis of effectiveness will be pain, measured periodically by means of clinical examination of Research Diagnostic Criteria for Temporomandibular Disorders. The cost-effectiveness ratio will be calculated using, as end points, pain and the ratio of the differences in costs between the groups studied. The evaluation of the impact of the treatment on quality of life will be determined by applying the adapted EuroQol-5D.
ETHICS AND DISSEMINATION: This protocol has been ethically approved by the local medical ethical committee, protocol number 2.014.339. Results will be submitted to international peer-reviewed journals and presented at international conferences.
TRIAL REGISTRATION NUMBER: NCT03096301.