Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia: Study protocol of a randomized, controlled trial (On&Out study).
Por:
Serrat M, Ferrés S, Auer W, Almirall M, Lluch E, D'Amico F, Maes M, Lorente S, Navarrete J, Montero J, Neblett R, Nijs J, Borràs X, Luciano JV and Feliu A
Publicada:
10 nov 2022
Ahead of Print:
10 nov 2022
Resumen:
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).
Filiaciones:
Serrat M:
Unitat d'Expertesa en Síndromes de Sensibilització Central, Servei de Reumatologia, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain
Escoles Universitàries Gimbernat, Autonomous University of Barcelona, Barcelona, Spain
Ferrés S:
Escoles Universitàries Gimbernat, Autonomous University of Barcelona, Barcelona, Spain
Department of Basic, Developmental and Educational Psychology, Faculty of Psychology, Autonomous University of Barcelona, Barcelona, Spain
Auer W:
Department of Basic, Developmental and Educational Psychology, Faculty of Psychology, Autonomous University of Barcelona, Barcelona, Spain
Almirall M:
Unitat d'Expertesa en Síndromes de Sensibilització Central, Servei de Reumatologia, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain
Lluch E:
Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Valencia, Spain
Physiotherapy in Motion, Multi-Specialty Research Group (PTinMOTION), Department of Physiotherapy, University of Valencia, Valencia, Spain
Pain in Motion International Research Group, Brussels, Belgium
D'Amico F:
Care Policy and Evaluation Centre (CPEC), London School of Economics and Political Science (LSE), London, United Kingdom
Maes M:
Department of Psychiatry, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
Lorente S:
Department of Psychobiology and Methodology of Health Science, Autonomous University of Barcelona, Barcelona, Spain
Pediatric Area, PNP, Hospital de Terrassa, Consorci Sanitari de Terrassa, Terrassa, Spain
Navarrete J:
Department of Basic, Developmental and Educational Psychology, Faculty of Psychology, Autonomous University of Barcelona, Barcelona, Spain
Psychological Research in Fibromyalgia and Chronic Pain (AGORA Research Group), Parc Sanitari Sant Joan de Déu, Barcelona, Spain
Montero J:
Psychological Research in Fibromyalgia and Chronic Pain (AGORA Research Group), Parc Sanitari Sant Joan de Déu, Barcelona, Spain
Warneford Hospital, Department of Psychiatry, University of Oxford, Oxford, United Kingdom
Neblett R:
PRIDE Research Foundation, Dallas, TX, United States
Nijs J:
Pain in Motion International Research Group, Brussels, Belgium
Pain in Motion Research Group (PAIN), Department of Physiotherapy, Human Physiology, and Anatomy, Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium
Department of Health and Rehabilitation, Unit of Physiotherapy, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
Borràs X:
Department of Basic, Developmental and Educational Psychology, Faculty of Psychology, Autonomous University of Barcelona, Barcelona, Spain
Psychological Research in Fibromyalgia and Chronic Pain (AGORA Research Group), Parc Sanitari Sant Joan de Déu, Barcelona, Spain
Luciano JV:
Psychological Research in Fibromyalgia and Chronic Pain (AGORA Research Group), Parc Sanitari Sant Joan de Déu, Barcelona, Spain
Department of Clinical and Health Psychology, Faculty of Psychology, Autonomous University of Barcelona, Barcelona, Spain
Feliu A:
Psychological Research in Fibromyalgia and Chronic Pain (AGORA Research Group), Parc Sanitari Sant Joan de Déu, Barcelona, Spain
Department of Clinical and Health Psychology, Faculty of Psychology, Autonomous University of Barcelona, Barcelona, Spain
gold, Green Published, Green Accepted
|