RESUMO
INTRODUCTION: The role of photobiomodulation (PBM) therapy for oral tissue damage induced by cancer treatment is currently unclear, and there is low-quality to moderate-quality evidence supporting the use of this approach for treating xerostomia and/or hyposalivation. Consequently, patients with head and neck cancer increasingly turn to basic oral hygiene to alleviate salivary gland dysfunction, and their adherence can be improved by mobile health (mHealth) education. The primary objective of this study will be to analyse the effects of different doses of PBM therapy (7.5 J/cm2 vs 3 J/cm2) plus mHealth education on quality of life (QoL), oral health, salivary secretion and salivary gland ultrasound assessment at postintervention and at the 6-month follow-up in patients with head and neck cancer after radiotherapy compared with those in control group. METHODS AND ANALYSIS: A prospective, three-arm, randomised, placebo-controlled, double-blinded study will be conducted among patients with head and neck cancer suffering from chronic xerostomia. A total of 20 patients per arm will be included and randomly assigned to receive 7.5 J/cm2 of PBM, 3 J/cm2 of PBM or placebo therapy. PBM therapy will be applied during 24 sessions at 22 points extra and intraorally two times per week for 3 months, combined with a mobile application (https://www.laxer.es). The assessments will be recorded at the beginning of the study, at postintervention and at the 6-month follow-up. The primary outcomes will be QoL, oral health, salivary secretion and salivary gland ultrasound. The pain pressure threshold, functional performance, mood and sleep quality will be secondary indicators. ETHICS AND DISSEMINATION: This study received ethics approval from the Andalusian Biomedical Research Ethics Portal (2402-N-21 CEIM/CEI Provincial de Granada) according to the Declaration of Helsinki for Biomedical Research. The results of this study will be presented at national and international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT05106608.
Assuntos
Neoplasias de Cabeça e Pescoço , Terapia com Luz de Baixa Intensidade , Xerostomia , Humanos , Qualidade de Vida , Estudos Prospectivos , Educação em Saúde , Xerostomia/etiologia , Xerostomia/terapia , Neoplasias de Cabeça e Pescoço/radioterapia , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Rheumatoid arthritis (RA) is the most common inflammatory rheumatic disease. RA symptoms make the disease disabling and strongly impact the quality of life of patients. Among the available forms of treatment, balneotherapy seems to be one of the most common forms of nonpharmacological treatment for rheumatic disease. The aim was to explore the effectiveness of balneotherapy for improving the quality of life of patients with RA. METHODS: Pubmed, Scopus, Web of Science and The Cochrane library were searched for randomized or clinical controlled trials published in English or Spanish until May 2021. Risk of bias of included articles were assessed using the Cochrane tool. A total 535 records were retrieved, and seven met the inclusion criteria. All the included studies showed statistically significant improvements in the quality of life of patients who received balneotherapy treatment despite differences in treatment administration. Sessions should be approximately 20 min long and use natural mineral waters enriched with elements, or mud, at a water temperature between 35-38 °C. CONCLUSIONS: Balneotherapy benefits the quality of life of people with RA. The obtained results show positive effects for both mineral bathing and immersion in sand or mud on the quality of life of people who suffer from RA.