Unitat d'Expertesa en Síndromes de Sensibilització Central, Servei de Reumatologia, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, 08035 Barcelona, Spain.
Escoles Universitàries Gimbernat, Autonomous University of Barcelona, Bellaterra (Cerdanyola del Vallès), 08193 Barcelona, Spain.
Int J Environ Res Public Health. 2021 Sep 30;18(19):10300. doi: 10.3390/ijerph181910300.
FIBROWALK is a multicomponent program including pain neuroscience education, therapeutic exercise, cognitive behavioral therapy and mindfulness training that has recently been found to be effective in patients with fibromyalgia (FM). This RCT started before the COVID-19 pandemic and was moved to a virtual format (i.e., online videos) when the lockdown was declared in Spain. This study is aimed to evaluate the efficacy of a virtual FIBROWALK compared to Treatment-As-Usual (TAU) in patients with FM during the first state of alarm in Spain. A total of 151 patients with FM were randomized into two study arms: FIBROWALK plus TAU vs. TAU alone. The primary outcome was functional impairment. Secondary outcomes were kinesiophobia, anxiety and depressive symptomatology, and physical functioning. Differences between groups at post-treatment assessment were analyzed using Intention-To-Treat (ITT) and completer approaches. Baseline differences between clinical responders and non-responders were also explored. Statistically significant improvements with small-to-moderate effect sizes were observed in FIBROWALK+TAU vs. TAU regarding functional impairment and most secondary outcomes. In our study, the NNT was 5, which was, albeit modestly, indicative of an efficacious intervention. The results of this proof-of-concept RCT preliminarily support the efficacy of virtual FIBROWALK in patients with FM during the Spanish COVID-19 lockdown.
FIBROWALK 是一个多组分方案，包括疼痛神经科学教育、治疗性运动、认知行为疗法和正念训练，最近已被证明对纤维肌痛 (FM) 患者有效。这项 RCT 在 COVID-19 大流行之前开始，并在西班牙宣布封锁时转为虚拟形式（即在线视频）。本研究旨在评估在西班牙第一次警戒状态期间，与常规治疗 (TAU) 相比，虚拟 FIBROWALK 在 FM 患者中的疗效。共有 151 名 FM 患者被随机分为两个研究组：FIBROWALK 加 TAU 与 TAU 单独治疗。主要结局是功能障碍。次要结局是运动恐惧症、焦虑和抑郁症状以及身体功能。使用意向治疗 (ITT) 和完成者方法分析治疗后评估时的组间差异。还探讨了临床反应者和非反应者之间的基线差异。与 TAU 相比，FIBROWALK+TAU 在功能障碍和大多数次要结局方面均观察到具有小到中等效应量的统计学显著改善。在我们的研究中，NNT 为 5，尽管适度，但表明干预措施有效。这项概念验证 RCT 的结果初步支持了在西班牙 COVID-19 封锁期间，虚拟 FIBROWALK 在 FM 患者中的疗效。
