经颅直流电刺激联合整骨疗法治疗慢性非特异性腰痛的疗效评价。随机对照试验的方案

IF 1.1 4区 医学 Q2 MEDICINE, GENERAL & INTERNAL International Journal of Osteopathic Medicine Pub Date : 2023-06-25 DOI:10.1016/j.ijosm.2023.100679
Danilo Armbrust , Carlos Luques Fonseca , Arislander Jonathan Lopes Dumont , Andrei Machado Viegas da Trindade , Hugo Pasin Neto , Claudia Santos Oliveira
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引用次数: 0

摘要

目的探讨骨科手法治疗(OMT)联合经颅直流电刺激(tDCS)治疗慢性非特异性腰痛(CNSLBP)的疗效。方法本研究为随机对照临床试验,分为三组,采用盲法评估者和参与者。这项研究将在巴西圣保罗圣保罗之家Misericórdia康复中心进行。参与者:72名男性和女性,患有CNSLBP。参与者将被随机分为三组,每组24名参与者(第一组:活跃tDCS +活跃OMT;第二组:安慰剂tDCS +安慰剂OMT;第三组:安慰剂tDCS +主动OMT)。评估将在干预方案前后以及整个过程结束后1个月进行。对于tDCS,每2周进行10次,每次20分钟(每周5次)。OMT将由整骨医生进行,每周一次,两次会诊,在第一次和第六次tDCS之前。主要观察指标:主要观察指标为视觉模拟疼痛量表,次要观察指标为Roland Morris残疾和EuroQol-5D生活质量问卷。分析统计分析将使用线性混合模型并基于意向治疗进行计算。显著性水平设为α = 5%。
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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

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%.

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来源期刊
CiteScore
2.20
自引率
36.80%
发文量
42
审稿时长
3 months
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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