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.

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 Training, in addition to Treatment As Usual (TAU), compared with TAU only in patients with Fibromyalgia (FM). Data were collected on the Revised Fibromyalgia Impact Questionnaire (FIQR) (primary outcome), and pain, fatigue, kinesiophobia, physical function, anxiety, and depressive symptoms (secondary outcomes) at baseline, at 12 weeks and, for the multicomponent group only, at six and nine months. An intention to treat (ITT) approach was used to analyse between-group differences. The effect size (Cohen's d) was reported for each pairwise comparison. Differences in baseline variables between responders (> 20% FIQR reduction) and non-responders were compared using the Student's t-test (quantitative variables) and χ²-test (categorical variables). Results. A total of 272 patients with FM were randomly assigned to either the multicomponent group (n = 135), who received the multicomponent treatment plus TAU or the TAU group (n = 137), who received TAU alone. Significant differences (p < .001) with a large effect size (Cohen’s d > 0.80) between the multicomponent group and TAU group were found for functional impact, 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. For all the baseline variables the non-responders showed a low effect size for depressive symptoms (Cohen’s d < 0.50). The number needed to treat (NNT) was 2 (95%CI 1.7 - 2.3).Conclusions. These results indicate that, when compared with TAU, this multicomponent treatment leads to beneficial effects in improving FM-related symptoms.Impact statement. ●This is the first study showing the beneficial effects of a multicomponent treatment that specifically integrates PNE in patients with Fibromyalgia.●This work provides new and useful information to promote a paradigm shift in the management of both FM and chronic pain.

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

“…The results of the present RCT show that the FIBROWALK intervention was efficacious (with small-to-moderate effect sizes) in reducing impairment, depression and anxiety symptoms and in improving physical functioning compared to TAU. Our results are consistent with previous research on the efficacy of online treatments for FM [ 61 , 62 , 63 ] and extend the already reported positive effects of FIBROWALK conducted in hospital [ 41 ] and outdoor [ 40 ] settings to virtual environments. It is worth noting that benefits associated with FIBROWALK administered in a virtual format were observed despite the extreme social circumstances happening when the RCT was carried out.…”

“…Further research of this treatment in primary care settings as well as in non-pandemic contexts might contribute to addressing these challenges. The online adaptation of the program was carried out as a result of the unexpected situation caused by the COVID-19 outbreak; this sudden program format adaptation—along with the variable IT knowledge of participants—may have contributed to increasing the dropout rate, which was higher than in previous RCTs using face-to-face FIBROWALK (38.7% vs. 23% [ 41 ]). However, it is also known that attrition rates are highly variable (4% to 54%) in online interventions for patients with chronic pain [ 80 ], so our results fell within the expected range.…”

“…Each video sent provided detailed guidelines explaining how to perform different home-based aerobic exercises (such as walking down the hallway at home); education in the neuroscience of pain (based on the book “Explain Pain” by David Butler, Lorimer Moseley and Arte Sunyata and the educational recommendations of the Pain in Motion team led by Jo Nijs); and CBT based on the analysis of basic psychological processes and aimed at decreasing anxiety and depressive symptoms, at reducing pain catastrophizing and at changing inadequate emotional regulation strategies. For greater detail on the FIBROWALK contents, see the study by Serrat et al [ 41 ]. A brief questionnaire (with 5 to 10 items) aimed at verifying if participants were actually involved in FIBROWALK virtual treatment was sent by email every week.…”

“…Furthermore, mindfulness training [ 39 ] has also been found to be an efficacious and cost-effective treatment for improving functional impairment, anxiety, depression, and quality of life in patients with FM [ 13 , 37 ]. 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 ].…”

“…The FIBROWALK program has proved to be an effective treatment for FM patients but, up to now, was only validated in hospital [ 41 ] and outdoor settings [ 40 ]. Given the need for moving effective treatments to the emerging field of telemedicine to continue providing support to patients with FM during the COVID-19 lockdown, the FIBROWALK program was adapted into a home-based virtual-format therapy.…”