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 with treatment as usual only in patients with fibromyalgia.

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 as the primary outcome were collected as were data for pain, fatigue, kinesiophobia, physical function, anxiety, and depressive symptoms (secondary outcomes) at baseline, 12 weeks, and, for the multicomponent group only, 6 and 9 months. An intention-to-treat approach was used to analyze between-group differences. Baseline differences between responders (>20% Revised Fibromyalgia Impact Questionnaire 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).

Conclusion: 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.

Impact: Despite some methodological shortcomings in the design of this study, the multicomponent therapy FIBROWALK can be considered a novel and effective treatment for patients with fibromyalgia. Physical therapists should detect patients with clinically relevant depression levels prior to treatment because depression can buffer treatment effects.

Lay summary: Fibromyalgia is prevalent and can be expensive to treat. This multicomponent treatment could significantly improve the core symptoms of fibromyalgia compared with usual treatment.

Trial registration: ClinicalTrials.gov NCT04284566.

Keywords: Cognitive Behavioral Therapy; Fibromyalgia; Mindfulness; Multicomponent Treatment; Pain Neuroscience Education; Therapeutic Exercise.