Effectiveness of a Multicomponent Treatment for Fibromyalgia Based on Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM): A Pragmatic Randomized Controlled Trial

Abstract

A recent study (FIBROWALK has supported the effectiveness of a multicomponent treatment based on pain neuroscience education (PNE), exercise therapy (TE), cognitive behavioral therapy (CBT), and mindfulness in patients with fibromyalgia. The aim of the present RCT was: (a) to analyze the effectiveness of a 12-week multicomponent treatment (nature activity therapy for fibromyalgia, NAT-FM) based on the same therapeutic components described above plus nature exposure to maximize improvements in functional impairment (primary outcome), as well as pain, fatigue, anxiety-depression, physical functioning, positive and negative affect, self-esteem, and perceived stress (secondary outcomes), and kinesiophobia, pain catastrophizing thoughts, personal perceived competence, and cognitive emotion regulation (process variables) compared with treatment as usual (TAU); (b) to preliminarily assess the effects of the nature-based activities included (yoga, Nordic walking, nature photography, and Shinrin Yoku); and (c) to examine whether the positive effects of TAU + NAT-FM on primary and secondary outcomes at post-treatment were mediated through baseline to six-week changes in process variables. A total of 169 FM patients were randomized into two study arms: TAU + NAT-FM vs. TAU alone. Data were collected at baseline, at six-week of treatment, at post-treatment, and throughout treatment by ecological momentary assessment (EMA). Using an intention to treat (ITT) approach, linear mixed-effects models and mediational models through path analyses were computed. Overall, TAU + NAT-FM was significantly more effective than TAU at posttreatment for the primary and secondary outcomes evaluated, as well as for the process variables. Moderate-to-large effect sizes were achieved at six-weeks for functional impairment, anxiety, kinesiophobia, perceived competence, and positive reappraisal. The number needed to treat (NNT) was 3 (95%CI = 1.6–3.2). The nature activities yielded an improvement in affective valence, arousal, dominance, fatigue, pain, stress, and self-efficacy. Kinesiophobia and perceived competence were the mediators that could explain a significant part of the improvements obtained with TAU + NAT-FM treatment. TAU + NAT-FM is an effective co-adjuvant multicomponent treatment for improving FM-related symptoms.

Effect of Multi-Modal Therapies for Kinesiophobia Caused by Musculoskeletal Disorders: A Systematic Review and Meta-Analysis

“…High-quality evidence reported that a long-lasting multi-modal program was superior to the exercise program in reducing disability, fear-avoidance beliefs and pain, and enhancing the quality of life of patients with different kinds of pain [ 15 ]. The effects were clinically tangible and lasted for at least one year after the intervention ended [ 15 , 20 , 22 ].…”

“…Therefore, not only the rehabilitation at the physical level but also the rehabilitation at the psychological level should be paid attention to [ 17 , 18 , 19 , 20 ]. At the same time, as mentioned above, kinesiophobia could be acquired through many different ways (e.g., personal experience, social learning) [ 11 ], therapies combined multi-modal from both psychological and physical perspectives had become increasingly popular [ 15 , 21 , 22 ]. However, at present, only a few studies focus on the advantage of multi-modal therapies over uni-modal therapies, and most of the studies on the rehabilitation of musculoskeletal disorders were limited to specific musculoskeletal disorders.…”

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

“…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.…”

Efectos de un programa de telerrehabilitación basado en ejercicio terapéutico aeróbico en pacientes con fibromialgia durante la pandemia de la COVID-19

“…En este sentido, la combinación de esta intervención con educación al paciente podría lograr mayores reducciones en la kinesiofobia y el catastrofismo ante el dolor de estos pacientes. Se ha sugerido que la educación al paciente podría ejercer un efecto positivo sobre estas variables a través de la reestructuración de cogniciones y creencias acerca del dolor y el movimiento, que podrían liderar cambios en el funcionamiento del SNC (Casey et al, 2020;Lee et al, 2018;Serrat et al, 2020). Sin embargo, el objetivo de este estudio fue analizar los efectos de un programa de telerrehabilitación basado en ejercicio terapéutico aeróbico de manera aislada.…”