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

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.

Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia: Study protocol of a randomized, controlled trial (On&Out study)

“…There are also some potential limitations that should also be recognized in this RCT. One of the main risks of this project may be dropouts and non-adherence, which are expected to be higher than in previous studies that only evaluated the short-term efficacy of the interventions (Serrat et al, 2020;Serrat et al, 2021a;Serrat et al, 2021b;Serrat et al, 2022b). In this regard, since previous studies showed very high adherence to the programs (over 90%; Serrat et al, 2020;Serrat et al, 2022b), a dramatically high dropout in the present study is not expected; however, to limit the effect of these dropouts and lack of adherence in our results, we will conduct several sensitivity analyses (ITT, completers, per protocol analysis).…”

“…Furthermore, there is evidence that exercising outdoors (vs. indoors) may also promote directed attention and social interactions, which may positively influence future intention of maintaining an exercise routine (Rogerson et al, 2016). Regarding the possible effects of the intervention format of the FIBROWALK intervention was found to be beneficial in hospital, outdoors and virtual settings at short term with apparently larger effect sizes in the outdoor format when compared to indoor hospital or online settings (Serrat et al, 2020;Serrat et al, 2021a;Serrat et al, 2021b;Serrat et al, 2022b). However, no clinical trial with a parallel design has yet been conducted to evaluate potential differences in the short-and the long-term efficacy between these different formats or in therapeutic adherence.…”

A Mixed Comparison of Interventions for Kinesiophobia in Individuals With Musculoskeletal Pain: Systematic Review and Network Meta-Analysis

“…For example, there is no direct comparison between psychological intervention and externally used devices in the network geometry. Last but not least, the score of TSK is usually reported as a secondary outcome, resulting in publication bias to some extent (Bennell et al, 2020 ; Öztürk et al, 2021 ; Serrat et al, 2021 ).…”

Kinesiophobia, Physical Activity, Depression, Anxiety and Stress Levels in Post COVID-19 Individuals: A Cross-Sectional Study

“…10 As our results firstly showed higher kinesiophobia, anxiety and stress levels in post-COVID-19 individuals, while the pandemic continues to afflict both patients with chronic conditions and other individuals, a multicomponent program consisting of pain neuroscience education, psychological support and/or physical activity counselling should be recommend to people recovering from COVID-19. 10,[15][16][17] Most of the post-COVID-19 individuals (93.1%) and healthy individuals (85%) were not sufficiently physically active in the current study. Barğı et al reported an positive linear association between physical inactivity and sedentary lifestyle as the duration of the pandemic has lengthened.…”