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

Autor: Serrat M, Juan Pablo Sanabria Mazo, Almirall M, Musté M, Feliu-Soler A, Méndez-Ulrich JL, Sanz A, Luciano JV
Rok vydání: 2021
Předmět:
Zdroj: PHYS THER
r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
instname
ISSN: 0031-9023
Popis: 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.
Databáze: OpenAIRE