Effectiveness of a Multicomponent Treatment based on Pain Neuroscience Education, Therapeutic Exercise, Cognitive Behavioural Therapy, and Mindfulness in Patients with Fibromyalgia (FIBROWALK study) : A Randomized Controlled Trial
Serrat, Mayte (Hospital Universitari Vall d'Hebron)
Sanabria-Mazo, Juan P.. (Parc Sanitari Sant Joan de Déu)
Almirall, Míriam (Hospital Universitari Vall d'Hebron)
Musté, Marta (Hospital Universitari Vall d'Hebron)
Feliu-Soler, Albert (Institut de Recerca Sant Joan de Déu)
Méndez Ulrich, Jorge Luis (Universitat Autònoma de Barcelona. Research Group on Stress and Health)
Sanz Ruiz, Antoni (Universitat Autònoma de Barcelona. Research Group on Stress and Health)
Luciano, Juan V. (Institut de Recerca Sant Joan de Déu)

Date:	2021
Abstract:	Methods. A randomised controlled trial (RCT) was carried out to evaluate the effectiveness of a 12-week multicomponent treatment based on pain neuroscience education, therapeutic exercise, cognitive behavioural therapy and mindfulness, in addition to treatment as usual (TAU), compared to TAU only in patients with fibromyalgia (FM). The multicomponent treatment (2h weekly sessions) was delivered in groups of 20 participants. TAU was mainly based on pharmacotherapy. We collected data on functional impairment (the Revised Fibromyalgia Impact Questionnaire [FIQR], as primary outcome), pain, fatigue, kinesiophobia, physical function, anxiety, and depressive symptoms (secondary outcomes) at baseline, at 12 weeks and, for the multicomponent group only, at 6 and 9 months. An intention to treat approach was used to analyse between-group differences. We also analysed baseline differences between responders (> 20% FIQR reduction) and non-responders and computed the number needed to treat (NNT). Results. A total of 272 patients with FM were randomly assigned to either the multicomponent treatment (n = 135) or TAU (n = 137). Significant between-group differences (p < . 001) with a large effect size (Cohen's d > . 80) were found for functional impairment, pain, kinesiophobia, and physical function, whilst differences with a moderate size effect (Cohen's d > 0. 50 and < 0. 80) were found for fatigue, anxiety, and depressive symptoms. Non-responders scored higher on depressive symptoms than responders at baseline. The number needed to treat was 2 (95% CI 1. 7 - 2. 3). Conclusions. Our results indicate that, when compared to TAU, the multicomponent treatment was effective for improving FM-related symptoms. Nevertheless, we must temper our findings in light of some methodological limitations in the study design. Impact statement. This is the first RCT showing positive effects on a wide range of clinical outcomes of a multicomponent treatment that integrates pain neuroscience education for patients with fibromyalgia. This work reports promising results and it might be the first step towards a paradigm shift in the management of fibromyalgia.
Rights:	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.
Language:	Anglès
Document:	Article ; recerca ; Versió de l'autor
Subject:	Fibromyalgia ; Multicomponent treatment ; Pain neuroscience education ; Therapeutic exercise ; Cognitive behavioural therapy ; Mindfulness ; Randomized controlled trial
Published in:	, 2021

DOI: 10.31234/osf.io/kj8sp
DOI: 10.1093/ptj/pzab200
PMID: 34499174

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > GIES (Grup de Recerca en Estrès i Salut)
Articles > Research articles
Articles > Published articles