Efficacy of the FIBROWALK Multicomponent Program Moved to a Virtual Setting for Patients with Fibromyalgia during the COVID-19 Pandemic : A Proof-of-Concept RCT Performed Alongside the State of Alarm in Spain
Serrat, Mayte (Escoles Universitàries Gimbernat i Tomàs Cerdà)
Coll-Omaña, Mireia (Universitat de Vic)
Albajes, Klara (Universitat Autònoma de Barcelona. Departament de Psicologia Bàsica, Evolutiva i de l'Educació)
Solé, Sílvia (Universitat de Lleida. Facultat d'Infermeria i Fisioteràpia)
Almirall, Míriam (Hospital Universitari Vall d'Hebron)
Luciano, Juan V (Universitat Autònoma de Barcelona. Departament de Psicologia Clínica i de la Salut)
Feliu-Soler, Albert (Universitat Autònoma de Barcelona. Departament de Psicologia Clínica i de la Salut)

Fecha:	2021
Resumen:	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.
Nota:	Ajuts: J.V.L. had a "Miguel Servet" research contract from the ISCIII (CPII19/00003) when the study was conducted. A.F.-S. and J.V.L. acknowledge the funding from the Serra Húnter program (UAB-LE-8015 and UAB-LE-120014, respectively). The funding bodies did not have any role in the analysis and interpretation of data, in the writing of the manuscript, or in the decision to submit the paper for publication.
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Fibromyalgia ; Multicomponent treatment ; Pain neuroscience education ; Therapeutic exercise ; Cognitive behavioral therapy ; Mindfulness ; Randomized controlled trial ; COVID-19 ; Online treatment ; Teletherapy
Publicado en:	International journal of environmental research and public health, Vol. 18 (september 2021) , ISSN 1660-4601

DOI: 10.3390/ijerph181910300
PMID: 34639600

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