Immune-inflammatory effects of the multicomponent intervention FIBROWALK in outdoor and online formats for patients with fibromyalgia.

The multicomponent intervention FIBROWALK integrates pain science education (PSE), therapeutic exercise, cognitive behavioral therapy (CBT), and mindfulness training for treating fibromyalgia (FM). This study investigated the effects of the FIBROWALK in online (FIBRO-On) and outdoor (FIBRO-Out) formats compared to treatment-as-usual (TAU) on core clinical variables along with serum immune-inflammatory biomarkers and brain-derived neurotrophic factor (BDNF). Furthermore, the predictive value of these biomarkers on clinical response to FIBROWALK was also evaluated. 120 participants were randomly divided into three groups: TAU, TAU + FIBRO-On or TAU + FIBRO-Out. Clinical and blood assessments were conducted pre-post treatment. Both FIBRO-Out and FIBRO-On showed effectiveness (vs TAU) by improving functional impairment and kinesiophobia. Individuals allocated to FIBRO-Out (vs TAU) additionally showed decreases in pain, fatigue, depressive symptoms, and serum IL-6 and IL-10 levels along with IL-6/IL-4 ratio; patients allocated to FIBRO-On only showed a less stepped increase in IL-6 compared to TAU. An exaggerated pro-inflammatory profile along with higher levels of BDNF at baseline predicted greater clinical improvements in both active treatment arms. Our results suggest that FIBROWALK -in online and outdoor formats- is effective in individuals with FM and has significant immune regulatory effects in FM patients, while immune-inflammatory pathways and BDNF levels may in part predict its clinical effectiveness. Trial registration number NCT05377567 (clinicaltrials.gov).