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; Coll-Omaña, Mireia; Albajes, Klara; Solé, Sílvia; Almirall, Miriam; Luciano, Juan V.; Feliu-Soler, Albert

doi:10.3390/ijerph181910300

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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

^1,2,*

^3,†,

⁴,

⁵

^1,‡

^6,7,‡

and

Albert Feliu-Soler

^6,7,‡

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

Eodyne Systems, Methodology, Methods, Models and Outcomes of Health and Social Sciences (M3O) Research Group, University of Vic, 08500 Vic, Spain

⁴

Department of Basics, Developmental and Educational Psychology, Faculty of Psychology, Autonomous University of Barcelona, Bellaterra (Cerdanyola del Vallès), 08193 Barcelona, Spain

⁵

Faculty of Nursing and Physiotherapy, University of Lleida, 25198 Lleida, Spain

⁶

Psychological Research in Fibromyalgia and Chronic Pain (AGORA Research Group), Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, 08950 Barcelona, Spain

⁷

Department of Clinical and Health Psychology, Faculty of Psychology, Autonomous University of Barcelona, Bellaterra (Cerdanyola del Vallès), 08193 Barcelona, Spain

Author to whom correspondence should be addressed.

^†

Mayte Serrat and Mireia Coll-Omaña contributed equally to this article and should be considered co-first authors.

^‡

These authors share senior authorship.

Academic Editor: Li Hu

Int. J. Environ. Res. Public Health 2021, 18(19), 10300; https://doi.org/10.3390/ijerph181910300

Received: 2 August 2021 / Revised: 20 September 2021 / Accepted: 24 September 2021 / Published: 30 September 2021

(This article belongs to the Special Issue Clinical and Health Psychology in Chronic Pain Management)

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Abstract

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. View Full-Text

Keywords: fibromyalgia; multicomponent treatment; pain neuroscience education; therapeutic exercise; cognitive behavioral therapy; mindfulness; randomized controlled trial; COVID-19; online treatment; teletherapy

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Serrat, M.; Coll-Omaña, M.; Albajes, K.; Solé, S.; Almirall, M.; Luciano, J.V.; Feliu-Soler, A. 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. Int. J. Environ. Res. Public Health 2021, 18, 10300. https://doi.org/10.3390/ijerph181910300

AMA Style

Serrat M, Coll-Omaña M, Albajes K, Solé S, Almirall M, Luciano JV, Feliu-Soler A. 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. International Journal of Environmental Research and Public Health. 2021; 18(19):10300. https://doi.org/10.3390/ijerph181910300

Chicago/Turabian Style

Serrat, Mayte, Mireia Coll-Omaña, Klara Albajes, Sílvia Solé, Miriam Almirall, Juan V. Luciano, and Albert Feliu-Soler. 2021. "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" International Journal of Environmental Research and Public Health 18, no. 19: 10300. https://doi.org/10.3390/ijerph181910300

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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

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