Evaluation of the effects of osteopathic manipulative treatment associated with transcranial direct current stimulation in chronic nonspecific low back pain. A protocol for a randomised controlled trial
Danilo Armbrust , Carlos Luques Fonseca , Arislander Jonathan Lopes Dumont , Andrei Machado Viegas da Trindade , Hugo Pasin Neto , Claudia Santos Oliveira
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Abstract
Objective
This study aimed to investigate the effects of osteopathic manipulative treatment (OMT) combined with transcranial direct current stimulation (tDCS) in individuals with chronic nonspecific low back pain (CNSLBP).
Methods
This will be a randomized controlled clinical trial of three groups with blinded evaluators and participants. The study will be conducted at the at the Rehabilitation Center of the Irmandade da Santa Casa de Misericórdia de São Paulo, São Paulo, Brazil.
Participants
72 participants of both sexes, with CNSLBP.
Intervention
Participants will be randomly allocated into three groups, with 24 participants per group (Group 1: active tDCS + active OMT; Group 2: placebo tDCS + placebo OMT; Group 3: placebo tDCS + active OMT). Assessments will be conducted before and after the intervention protocol and 1 month after the end of the entire process. For tDCS, 10 sessions of 20 minutes over 2 weeks (5 sessions per week). OMT will be performed by an osteopath, with two consultations, one per week, before the first and sixth sessions of tDCS.
Main outcome measures
The primary outcome will be the visual analog pain scale, and the Roland Morris disability and EuroQol-5D quality of life questionnaires will be used as secondary.
Analysis
The statistical analysis will be calculated using linear mixed models and based on intention-to-treat. The level of significance will be set at α = 5%.
期刊介绍：
The International Journal of Osteopathic Medicine is a peer-reviewed journal that provides for the publication of high quality research articles and review papers that are as broad as the many disciplines that influence and underpin the principles and practice of osteopathic medicine. Particular emphasis is given to basic science research, clinical epidemiology and health social science in relation to osteopathy and neuromusculoskeletal medicine.
The Editorial Board encourages submission of articles based on both quantitative and qualitative research designs. The Editorial Board also aims to provide a forum for discourse and debate on any aspect of osteopathy and neuromusculoskeletal medicine with the aim of critically evaluating existing practices in regard to the diagnosis, treatment and management of patients with neuromusculoskeletal disorders and somatic dysfunction. All manuscripts submitted to the IJOM are subject to a blinded review process. The categories currently available for publication include reports of original research, review papers, commentaries and articles related to clinical practice, including case reports. Further details can be found in the IJOM Instructions for Authors. Manuscripts are accepted for publication with the understanding that no substantial part has been, or will be published elsewhere.
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