Effectiveness of a Multicomponent Treatment Based on Pain Neuroscience Education, Therapeutic Exercise, Cognitive Behavioral Therapy, and Mindfulness in Patients With Fibromyalgia (FIBROWALK Study): A Randomized Controlled Trial

Abstract

Objective. The purpose of this study was to evaluate the effectiveness of a 12-week multicomponent treatment based on pain neuroscience education, therapeutic exercise, cognitive behavioral therapy, and mindfulness—in addition to treatment as usual—compared to treatment as usual only in patients with fibromyalgia (FM). Methods. This randomized controlled trial involved a total of 272 patients who were randomly assigned to either multicomponent treatment (n = 135) or treatment as usual (n = 137). The multicomponent treatment (2-hour weekly sessions) was delivered in groups of 20 participants. Treatment as usual was mainly based on pharmacological treatment according to the predominant symptoms. Data on functional impairment using the Revised Fibromyalgia Impact Questionnaire (FIQR) as the primary outcome were collected as were data for 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 analyze between-group differences. Baseline differences between responders (>20% FIQR reduction) and nonresponders also were analyzed, and the number needed to treat was computed. Results. At posttreatment, significant between-group differences with a large effect size (Cohen d > 0.80) in favor of the multicomponent treatment were found in functional impairment, pain, kinesiophobia, and physical function, whereas differences with a moderate size effect (Cohen d > 0.50 and < 0.80) were found in fatigue, anxiety, and depressive symptoms. Nonresponders scored higher on depressive symptoms than responders at baseline. The number needed to treat was 2 (95% CI = 1.7–2.3). Conclusions. Compared with usual care, there was evidence of short-term (up to 3 months) positive effects of the multicomponent treatment for fibromyalgia. Some methodological shortcomings (eg, absence of follow-up in the control group and monitoring of treatment adherence, potential research allegiance) preclude robust conclusions regarding the proposed multicomponent program.

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.…”

“…It consists of 21 items answered on a 0-10 numerical scale and is divided into three dimensions: physical dysfunction (score ranges from 0 to 30), overall impact (score ranges from 0 to 20), and intensity of symptoms (scores from 0 to 50), with higher scores indicating greater functional impairment of FM. The FIQR might be considered the gold standard instrument for assessing multidimensional function/health-related quality of life (FIQR total score) and has been used in several RCTs as a main outcome for assessing the clinical impact of non-pharmacological interventions (e.g., 13,40,41). The Spanish version shows excellent internal consistency (Cronbach's α = 0.91) [50]; in our sample, the α was 0.94.…”

“…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.…”