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.

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

doi:10.3390/ijerph181910300

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.

Highlights

Fibromyalgia (FM) is a chronic syndrome, of unknown etiology, characterized by widespread musculoskeletal pain and multiple concomitant symptoms, including fatigue and sleep disturbances, with an estimated prevalence of between 0.2 and 6.6% worldwide [1], and of 2.45% in Spain [2].FM frequently coexists with psychological distress, anxiety, depression and other comorbid conditions such as chronic fatigue syndrome [1,3,4]
Regarding therapy components proved to be effective in FM, Pain Neuroscience Education (PNE) [18,19,20,21,22,23,24,25,26,27,28] is aimed at changing patients’ pain beliefs, emphasizing how overprotective behaviors can modulate pain experience [29,30,31], and it has been found to be effective for reducing pain disability, catastrophizing, avoidance behaviors and physical inactivity in patients with FM [32]
The virtual FIBROWALK program arose as a necessity to provide health support for patients with FM when the COVID-19 pandemic broke out, and comprised weekly videos on PNE, home-based therapeutic exercise, Cognitive Behavioral Therapy (CBT) and mindfulness training

Summary

Introduction

FM frequently coexists with psychological distress, anxiety, depression and other comorbid conditions such as chronic fatigue syndrome [1,3,4]. The function of the descending nociceptive inhibitory pathway [6,7] is known to be altered by cognitive biases—such as maladaptive thoughts—along with emotional and behavioral factors, which, in turn, further potentiate the pain experience [8,9]. Cognitive Behavioral Therapy (CBT) and therapeutic exercise are core pillars of intervention in FM [33,34,35], and combining both has been seen to be effective at treating several FM symptoms [36,37,38] (e.g., relieving pain, fatigue, depression, and improving psychological well-being and physical functioning [12,33]). The FIBROWALK program is an evidence-based multicomponent strategy based on the combination of the aforementioned therapeutic components with positive results in two recent RCTs in FM [40,41]

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