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.

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.