Author:
Serrat Mayte,Ferrés Sònia,Auer William,Almirall Míriam,Lluch Enrique,D’Amico Francesco,Maes Michael,Lorente Sonia,Navarrete Jaime,Montero-Marín Jesús,Neblett Randy,Nijs Jo,Borràs Xavier,Luciano Juan V.,Feliu-Soler Albert
Abstract
Introduction: The On&Out study is aimed at assessing the effectiveness, cost-utility and physiological 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 effectiveness nor their long-term effects. For the first time, this study will also evaluate the cost-utility (6-month time-horizon) and the effects on immune-inflammatory biomarkers and Brain-Derived Neurotrophic Factor (BDNF) levels of both interventions. The objectives of this 6-month, randomized, controlled trial (RCT) are 1) to examine the effectiveness and cost-utility of adding FIBRO-On or FIBRO-Out to Treatment-As-Usual (TAU) for individuals with fibromyalgia (FM); 2) to identify pre–post differences in blood biomarker levels in the three study arms and 3) to analyze the role of process variables as mediators of 6-month follow-up clinical outcomes.Methods and analysis: Participants will be 225 individuals with FM recruited at Vall d’Hebron University Hospital (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 impairment, pain, fatigue, depressive and anxiety symptoms, perceived stress, central sensitization, physical function, sleep quality, perceived cognitive dysfunction, kinesiophobia, pain catastrophizing, psychological inflexibility in pain and pain knowledge will be conducted pre-intervention, at 6 weeks, post-intervention (12 weeks), and at 6-month follow-up. Changes in immune-inflammatory biomarkers [i.e., IL-6, CXCL8, IL-17A, IL-4, IL-10, and high-sensitivity C-reactive protein (hs-CRP)] and Brain-Derived Neurotrophic Factor will be evaluated in 40 participants in each treatment arm (total n = 120) at pre- and post-treatment. Quality of life and direct and indirect costs will be evaluated at baseline and at 6-month follow-up. Linear mixed-effects regression models using restricted maximum likelihood, mediational models and a full economic evaluation applying bootstrapping techniques, acceptability curves and sensitivity analyses will be computed.Ethics and dissemination: This study has been approved by the Ethics Committee of the Vall d’Hebron Institute of Research. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media and various community engagement activities. Trial registration number NCT05377567 (clinicaltrials.gov).
Funder
Ministerio de Ciencia e Innovación
Subject
Physiology (medical),Physiology
Reference137 articles.
1. Brain glial activation in fibromyalgia - a multi-site positron emission tomography investigation;Albrecht;Brain Behav. Immun.,2019
2. The Spanish version of the SF-36 health survey (the SF-36 health questionnaire): An instrument for measuring clinical results;Alonso;Med. Clin.,1995
3. How much is needed? Comparison of the effectiveness of different pain education dosages in patients with fibromyalgia;Amer-Cuenca;Pain Med.,2020
4. Immune-inflammatory pathways and clinical changes in fibromyalgia patients treated with mindfulness-based stress reduction (MBSR): A randomized, controlled clinical trial;Andrés-Rodríguez;Brain Behav. Immun.,2019
5. Financial, occupational, and personal consequences of disability in patients with chronic fatigue syndrome and fibromyalgia compared to other fatiguing conditions;Assefi;J. Rheumatol.,2003
Cited by
1 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献