cost-utility and immuno-inflammatory effects of the fibrowalk in patients with fibromyalgia (the on&out study)

Conditions: Fibromyalgia

Summary: the present project will evaluate through a randomised controlled clinical trial with 6-month follow-up, the efficacy and cost-utility (6-month time horizon) of the multicomponent fibrowalk programme in an online (i.e., fibro-on) and outdoor (i.e., fibro-out) adjunctive to usual care (hc) format, as compared to hc. in order to determine the mechanisms of action of the clinical effects of the interventions studied 6 months after the start of treatment, pre-post changes will be evaluated in various psychological variables considered to be mediators from a theoretical point of view, as well as in immuno-inflammatory markers with evidence of alteration in fm and/or potentially modifiable by the interventions proposed (i.e. il-6, cxcl8, il-17a, il-4, il-10, high-sensitivity c-reactive protein). in the field of personalised treatment in chronic pain, the design of the present study with 3 treatment branches will also make it possible to establish whether certain patient profiles or baseline psychobiological characteristics can predict the short- and medium-term clinical response to the treatments studied.

introduction: the on\&out study is aimed at assessing the efficacy, cost-utility and immuno-inflammatory underpinnings of the fibrowalk multicomponent intervention conducted in two different settings: online (fibro-on) or outdoors (fibro-out). both interventions have proved to be efficacious in the short-term but there is no study assessing their comparative efficacy nor their long-term effects. this study will also evaluate the cost-utility (6-month time-horizon) and the effects in blood biomarkers level of both interventions for the first time. the objectives of this 6-month, randomized, controlled trial (rct) are (i) to examine the efficacy and cost-utility of adding fibro-on or fibro-out to treatment-as-usual (tau) for individuals with fibromyalgia; (ii) to identify pre-post differences in levels in blood biomarkers in the three study arms and (iii) to analyze the role of some psychological process variables as mediators of 6-month clinical outcomes. methods and analysis: participants will be 225 individuals with fibromyalgia recruited at vall d'hebron institute of research (barcelona, spain), randomly allocated to one of the three study arms: tau vs tau+fibro-on vs tau+fibro-out. a comprehensive assessment to collect functional impact, pain, fatigue, depressive-anxiety symptoms, physical function, kinesiophobia, pain catastrophism, quality of life, costs, and psychological process variables will be conducted pre-intervention, at half of the intervention (6 weeks, post-intervention (12 weeks), and at 6-month follow-up. changes in immuno-inflammatory biomarkers (i.e. il-6, cxcl8, il-17a, il-4, il-10, and high-sensitivity c reactive protein) and brain-derived neurotrophic factor will be evaluated in 50% of the sample at pre- and post-treatment. linear mixed-effects models using restricted maximum likelihood, mediational models and a full economic evaluation applying bootstrapping techniques, acceptability curves and sensitivity analyses will be computed.

Eligibility criteria:
inclusion criteria: 1. patients of both sexes, between 18 and 65 years of age. 2. diagnosis of fibromyalgia according to the acr 2010/2011 criteria. 3. understanding spanish. exclusion criteria: 1. psychological treatment (within the last year) or current. 2. comorbid presence of severe mental disorder (e.g. schizophrenia) or other terminal clinical conditions or scheduled treatments that may interrupt study follow-up. 3. inability to complete the weekly sessions/modules of the programme on a regular basis. 4. being in litigation with the health system with the aim of obtaining a permanent leave of absence.

Keywords: fibromyalgia cost-utility multicomponent treatment randomized controlled trial biomarkers